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Recommendations for the Safe Prevention of the Primary Cesarean Delivery
Georgia has seen an increase in the number of C-sections: a more than threefold rise of the national average, which increased over the past decade from 9.3% in 2000 to 41.6.5% in 2015. However, awareness or concern about these increasing rates among society, (future) clients and health professionals is not universal till Ministry of Labour Health and Social Affairs issued a plan aimed to decrease CS rate But long before, in 2012, GOGA with partners conducted a study aimed to determine factors leading to in the country, and how clients and providers perceive this increase the increased number of C-sections
The study did not assess whether individual C-sections were medically indicated or not, and hence it did not seek to ascertain whether the observed increase was related to any increase in medical conditions predisposing to C-sections. Whilst there are no indications that such is the case, the study did look into determinants of C-sections in Georgia, in particular the demand and supply factors underlying those C-sections without an apparent medical need.
The claim of midwives and obstetricians/gynaecologists that one of the main reasons for the high CS rate is the increasing request by clients cannot be confirmed by the study. While the majority of pregnant women and a great number of those whose pregnancy resulted in a C-section do prefer a vaginal (‘normal’) delivery, it is true that quite a substantial number of women preferred a surgical delivery, or mentioned that the C-section took place at their own request, even if there was no medical indication. It was striking to note that 31% of women who underwent a C-section could not mention the reason why they had undergone surgery. It was even more striking that for more than two thirds of the women the decision on the C-section was taken during pregnancy; and for one third this decision was even taking during the first trimester of their pregnancy. Overall, the study findings illustrate a lack of information and a great deal of anxiety on the side of pregnant women about pregnancy and delivery, including fear for pain, which may trigger their preference for undergoing a C-section rather than have a normal delivery.
Perverse financial issues may well be a determinant of the high CS rate in Georgia, though this is hard to substantiate because of the sensitiveness of the issue. Respondents were hesitant to elaborate on this, and therefore only a few anecdotal remarks can be made. Some providers mentioned that they had performed C-section on demand because they felt pressured by the clients, and did not want to loose them as clients.
One of the findings worth investigating more in-depth is the area of pain control/management during a vaginal delivery and anaesthesia during a C-section. Regarding the latter, providers seem to prefer endotracheal anaesthesia instead of regional (spinal) anaesthesia which is recommended by the WHO. Some 70% of the C-section was performed with endotracheal anaesthesia, and among this group the largest part was found in the regions. This finding does indicate many gaps among the providers when it comes to modern methods of anaesthesia, including in skills, information, training, and confidence.
A lack of information on pain control methods during a vaginal delivery, and possibly access to such methods, may also be a determinant of demand for C-sections among women. The study did find that quite a number of pregnant women consider a C-section less painful than a vaginal delivery, and that fear of pain is a reasonable argument for having a C-section. Midwives stated that fear of pain has motivated quite some women to have a C-section, however that such practices could be curtailed by providing access to and information on pain control and management (such as the use of epidural anaesthesia) during delivery. Overall, increased access to pain control methods may positively influence a woman’s preference for a normal ‘vaginal’ delivery. On the other hand, such methods require specific skills/training, which may be the reason for their low use.
According to the midwives, the lack of information is a serious shortcoming in perinatal care. As midwives suggested, better-informed clients are significantly less stressed before or during childbirth thereby reducing the need for unnecessary medical interventions, hence the risks of bad maternal and/or neonatal outcomes. The antenatal period should be more than just a medical check-up, allowing women and their partners to prepare themselves for the delivery and their parenting role. Unfortunately the role of the midwife in the antennal period is limited or, as in most cases, practically non-existent. This has become the domain of the WCC’s and within these centres that of the Ob/Gyn. Midwives make a claim for better birth-preparedness of pregnant women. One way in which this could be achieved is through the concept of ‘Parents’ Schools’. Study findings demonstrate the interest of midwives to broadening their scope of work to include antenatal and postnatal care. To a certain extent, they are supported by some of the obstetricians/gynaecologists, who would see an enhanced role for the midwife. This group however is still a minority.
Almost all Ob/Gyn know that the C-section rate in Georgia has increased, though not all see this as a cause for great concern. Those who do, generally have a better understanding of the international recommendations, and also tend to work in MH/MUs with lower CS rates. According to the group of Obs/Gyns, the main reason for this trend is the increased demand of clients, leaving them with few options to refuse for fear of losing clients, income. In addition, some feel legally unprotected and they are therefore inclined to performing C-sections. National guidelines and medical protocols are absent, and common (evidence-based) standards are not well known. As the analysis of the delivery log shows, a majority of the breech presentations results in C-section and also a substantial amount of multiple foetuses are seen as medical indications for delivering in a surgical manner. Lastly, the call for national guidance also stretches out to rules and regulations on the management side. The study has shown that facilities that introduced measures to curb the trend of increased CS rate, fail to achieve their goals because such measures can’t be implemented in isolation.
Conclusions
The reasons for the high and increasing rate of C-sections in Georgia are multiple, and there are clear indications that the high rate is the result of the combined effects of:
(a) Women having little information about pregnancy and about the physiology of a natural delivery, and the associated fear for pain and for the possibility that something may go wrong.
(b) Service providers not having all the required technical knowledge and skills, not sufficiently adhering to professional standards and, in some cases, being sensitive to perverse financial incentives that easily make them resort to surgical interventions.
The exact weight of each of the above factors is not known for the time being. It would require more in-depth studies and / or different types of study (such as medical audits on management of pregnancy and delivery by medical professionals).
Some important conclusions however can be drawn in relation to the specific objectives that have guided the present study. Below an overview of the main conclusions organised around the 7 study objectives.
Objective 1: Trends in Caesarean section rates
- NCDC data illustrated that the rate of deliveries taking place through C-sections in Georgia increased from 9.3% in 2000 to 31.5% in 2010, which is more than threefold over a period of 10 years. The percentage of C-sections in the sample is higher than the national average of (32%). A slightly higher percentage of the C-sections are first deliveries (55%, against 45% repeat deliveries). In SLR the percentage CS is well below the averages nationally and in the sample (18%); this figure is higher in private facilities and JSC: 40% and 35% respectively.
- The rates vary greatly from one institution to the other, with some health facilities having C-section rates of well over 50%. Almost half of the C-sections are planned in advance, whereas the other 50% concerns emergency C-sections. This trend has not changed significantly over the past decade.
- The C-section rate in Societies with Limited Responsibility (previously public institutions) is much lower than that in private facilities and joint stock companies: 19.7% versus 32-33%.
- About 50% of all C-sections are planned in advance, that is before onset of labour. The other half involves emergency C-sections, which are decided upon after onset of labour. The distribution of planned versus emergency CS appears about equal (50%-50%) and relatively consistent over time.
- The percentage planned CS in case of a repeat delivery saw the highest increase over the past decade (compared to the other categories): from 20% in 2000 and 39% in 2010.
Objective 2: Regional/geographical variations in Caesarean section rates
- NCDC data show the wide variation in C-section rates in the country: in some regions the rate was 77%, whereas as low as 10% in other regions. Data from the delivery logs confirm these regional variations.
Objective 3: Obstetrical complications, reasons for Caesarean sections
- National data on deliveries do not state the reasons for the C-sections, making it impossible to distinguish which proportion of C-sections are conducted based on medical indications (and which type of medical indication).
- In none of the MHs the forceps is being used. Only nine vaginal deliveries were assisted through vacuum procedure. This figure is considered very low and may indicate lack of practical skills to perform this procedure. Correct implementation of forceps or vacuum assisted vaginal deliveries might have prevented surgical interventions.
- Cephalic presentations beyond 37 weeks (without stimulation): 24% of such cases ended in CS (604 of the 2477). C-sections in this category are more frequent among first deliveries.
- The group with the lowest risk of C-section (on average 2-3%) is: repeated vaginal delivery, with a single foetus and cephalic pregnancy (>37 weeks gestation without stimulation and spontaneous delivery). The findings in this study show a percentage of 15% in this subgroup, which suggests that a more than average percentage of C-sections in this subgroup was conducted without medical indication.
- Another group with a relative low risk of C-section (on average 14-15%) is: first vaginal delivery, with a single foetus and cephalic pregnancy (>37 weeks gestation without stimulation and spontaneous delivery). The main reasons for C-Section in this sub-group are complications during labour, such as dystocia or foetal distress. According to our study the percentage of C-Section in this sub-group is 32%, which suggests undue C-Sections, not justified by any medical indication.
- The percentage of stimulation in all groups of cephalic presentation > 37 weeks is significantly low (45 among first deliveries and 14 among repeat deliveries), which indicates that stimulation of delivery is not a common practice in Georgia.
- Almost all (one exception) of the 33 transversal presentations lead to C-section. The vast majority of the breech presentations (83%) resulted in C-section. This figure is even higher among breech presentations in case of a first delivery: 94%. In case of a breech presentation (repeat delivery) this figure is much lower with 67%.
- 66% of the multiple foetuses were delivered through C-section.
Objective 4: Comparison between pregnant women, those that underwent CS, and those who had a vaginal delivery
- The majority of the births are from mothers between 21 and 35 years of age (VD and CS). With increasing age, the number of C-section increases: from 30% in the under 20 year olds to 36% in the age group 21-35 years and 56% in the women over 36 years of age.
- A majority of the women in the study were not insured and had to pay for the delivery out of their own pockets. This percentage is the highest among pregnant women (72%); close to two thirds (65%) of the women who had a vaginal delivery and 57% of the women who underwent CS.
- A majority of the women (with VDs or C-section) deliver in private MHs, this trend is consistent among all the three age groups. Compared to women in the other two age groups, women over 36 years appear to prefer the private sector (private and JSC combined) for the delivery, whether for VD or CS. Among the women with CS there is also no major difference between the age groups in terms of type of facility, except for women over 36 years of age, where only one woman of that age group had a C-section in an SLR for the CS.
- Despite the fact that a vast majority of the women had visited a Women’s Consultation Centre during her pregnancy, the overall level of information and birth preparedness is low and appears insufficient. Of the pregnant women 60% claimed to be well prepared, though a significant number stated to be afraid of the pain during delivery and have limited information. Less than half of the women who had a vaginal delivery indicated that the information was sufficient; some 28% indicated that they had received little information; and 9% was not informed at all.
- Despite the fact that a majority of the women (all three groups) have visited the Women’s Consultation Centres, not all seem well prepared for the delivery. Almost all women who had a C-section could mention which type of anaesthesia was used. 70% of women with C-section received endotracheal anaesthesia instead of regional (spinal) anaesthesia, which is recommended by WHO. There are stark regional differences in the use of anaesthesia. In Tbilisi there is low endotracheal use, which in contrast in the regions is the preferred type of anaesthesia.
Objective 5: Providers’ perspective on C-sections
Midwives
- The average age of the midwives in the study was 45, the youngest 23 and the oldest included was 68 years old (who had 35 years of experience and had worked for 42 years at the same facility). On average, midwives included in the study had 19 years of experience as a midwife. A majority of the midwives (74%) had participated in trainings.
- The midwives were asked to respond to the questions on their actual and preferred role during different stages in the perinatal period. Only a few respondent midwives are involved in more than one stage of perinatal care. Many are working under the supervision of the Ob/Gyn, though quite a large number (38) indicate that they are trained and confident enough to work independently without supervision of the doctors. Less than 10% are currently involved in the antenatal period; though many (66%) do see a role for themselves in ANC. For a majority of the midwives their actual role during C-section is to receive a newborn, only a few (14 respondents) mentioned that they prepared pregnant women before the surgery. Midwives generally do not see an increased role for them in C-sections.
- Perception on C-section. A vast majority of the midwives (80%) see an increased trend in the number of C-section that is being performed at their MH/MU; most of them generally also know the reason why a C-section was performed. According to them, fear of pain during a ‘normal’ vaginal delivery is the main reason why the CS rate has increased. Some midwives had observed that in spite of efforts of Ob/Gyn to convince women on the possibility of delivering in a normal way, women still prefer CS. And although more than half of the respondents thought that many of the C-sections at their MH/MU could be avoided, only 21 explained how. Some of the midwives thought that unnecessary C-sections could be avoided in case of improved pain control methods and pain management; others saw the need to improve the level information among pregnant women. They were of the impression that many C-sections are being performed due to clients’ demand mainly because of a lack of information on pregnancy and delivery. Almost a third (30%) of the midwives stated that pressure from the husband/partner was one of the main reasons for C-section.
- The midwives were asked to indicate areas for improvement in perinatal care. Three main areas mentioned were: need to establish Parents’ Schools; implement new guidelines; increase awareness among the population on safe motherhood, delivery and C-sections.
Obstetricians/gynaecologists
- The average age of the Ob/Gyns was 49; the vast majority having more than 10 years of professional experience, with the oldest participant (75 yrs) practicing 50 yrs in the same MH/MU. A majority of the Ob/Gyn works in one health facility only; and about one third has never changed their workplace since they started practicing. A majority of the Ob/Gyn participated in trainings, predominantly trainings on contraception and family planning.
- Perspective on role of the midwife: Ob/Gyns indicate that they are hindered in their work by the lack of protocols and national guidelines (which would give them not only information but also some protection). Also, use of the partogram in health facilities is not universal, some 12% of Ob/Gyns do not use it. Close to half of the Ob/Gyn would not trust midwives to fill the partogram because of limited skills, however about a similar percentage trusts midwives to perform Active Management of the Third Stage of Labour independently and keep some steps of the ‘warm chain’. A majority of the Ob/Gyn recognized that midwives have no a role in C-sections and 46 do also not see a role for them in this part of the work. Those who do see a role (64) mention for example preparing clients for the surgery, or receiving the newborn after the medical intervention. 77 thought that it is not possible to increase the participation of midwives in CS. On the questions regarding the role of the midwife in other aspects of perinatal care, the group was divided: half of the Ob/Gyn did not see a role for the midwife in the antenatal period, whereas the other half does encourage the involvement of midwives, for example in Parents’ Schools. According to some, it is important to increase the independence of midwives, under conditions of supervision and monitoring by the Ob/Gyn; about one fifth see a role for midwives in the postnatal period.
- Perspectives on C-sections: The obstetricians/gynaecologists generally do not think there has been a change over time in the type of conditions that are considered ‘obstetrical complications’, and in particular those that require C-sections. But 12% do think that there has been a change, but could not substantiate it.
- Almost all Ob/Gyn thought that the number of C-sections in Georgia had increased during the last 5 years. 63% attributed this increase mainly to the demand of clients. Only one respondent does not believe that the rate has increased. On the question regarding the knowledge on international recommendations of C-section rate, quite a number of respondents did not give a correct estimate. More than one third (37%) indicate that they know the recommended range, but do not concretise. 27% of the obstetricians/gynaecologists state that they do not know the international recommendation. Some 22% gave a correct answer (mentioning between 8% and 15%). 4% gave the wrong answer and another 4% was close to the right answer.
- 17% of the respondents did not know the CS rate in their own MH/MU. More than half mentioned percentages of 20% and beyond and some even mentioned figures up to 75%. On the follow-up question whether they considered the CS rate in their MH/MU a problem, interestingly quite a number of Ob/Gyn did not consider the CS rate a problem. On the other hand, some Ob/Gyn stated the high CS rate to be a problem, even when the rates in their own facilities were within the international recommendations. Overall, 60% considered the CS rate as a problem.
- The respondents were asked whether they would change anything in their MH/MU if they were in a position to make changes regarding perinatal/maternal health. One third would not make changes; however a majority would. Suggestions included: the establishment of Parents’ Schools; improve information to pregnant women; monitor the C-Section rate; raise awareness within the society on C-sections. Some 10% indicated the need to clarify medical indications (i.e. on whether or not conduct C-section in case of breech presentation and repeated C-Section), and some see the need to implement the guidelines on CS.
Objective 6: To obtain the clients’ perspectives on C-sections, including their current levels of information level and their attitudes, and the reasons why women themselves at times request for C-sections.
- It is striking to note that a relatively high number of women who underwent a C-section lacked information: among the women with C-section, 31% was not able to indicate the reason why they had the C-section. Only 40% of the women who underwent C-section reported to be satisfied with the information received. Of the remaining 60%, half had missed information and did not know what the C-section involved; and another 30% had received none, or just little information about the delivery. It is even more striking to report that those who report to be insufficiently informed it had been a planned C-section (67%).
- Of the group women who underwent a C-section, the level of being informed is the lowest in the regions as compared to women who delivered in Tbilisi. For a small majority of the women (58%), their main source of information had been their physician. Friends were the second largest source of information (21%), and the rest got their information through other channels. Only one woman mentioned the midwife as her source of information.
- Another striking finding is that 31% of the women who had undergone C-section could not state the reason for the surgical delivery. The reasons for the CS vary from medical conditions on the one hand (during pregnancy or during delivery) to other reasons such as fear of the delivery, and mostly fear for pain during the delivery. Some had opted for C-section because they had planned sterilization and hence could save on costs.
- Regarding their experience with the C-section, about half were happy with the decision because of the health problem. Some regret, and mention that if they would have had more information and are more prepared, they would have preferred a vaginal delivery. 13 women were happy at the beginning, but had changed their opinion after the delivery. Quite a few were happy with the surgery because it all finished quickly.
- A small majority of the women who underwent a C-section (59%) would like to have a vaginal delivery in case of a future pregnancy; the percentage opting for another C-section is relatively higher in the regions, as compared to those who delivered in Tbilisi. Of the pregnant women, the vast majority (81%) prefers a vaginal delivery. Of the remaining who preferred a C-section only 22% had a clear medical indication, 25% followed the doctor’s advice and 53% was going to have the C-section because of their own request.
- An overwhelming majority of the women were very satisfied with the services (all three subgroups), and rated them with a high number. Almost half of the women who underwent a C-section mentioned at this stage of the interview (the end) that they wished they had delivered vaginally.
Objective 7: To find out at which stage of pregnancy the decision as to the type of delivery is being taken (physiological delivery or C-section).
- In 69% of the cases, the decision to perform a C-section was taken during pregnancy; for the other 31% during labour.
- Of those who had taken the decision during pregnancy, roughly one third had taken the decision during the first and second trimester, and for the remainder the decision was taken during the third trimester. This suggests that there is no medical indication, since the most frequent indications for C-sections (i.e. dystocia or failure to progress in labour, breech presentation, foetal distress) can be diagnosed only in the late stage of pregnancy or during labour.
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Recommendations |
Grade of Recommendations |
First stage of labor |
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A prolonged latent phase (eg, greater than 20 hours in nulliparous women and greater than 14 hours in multiparous women) should not be an indication for cesarean delivery. |
1B |
Strong recommendation, moderate quality evidence |
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Slow but progressive labor in the first stage of labor should not be an indication for cesarean delivery. |
1B |
Strong recommendation, moderate quality evidence |
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Cervical dilation of 6 cm should be considered the threshold for the active phase of most women in labor. Thus, before 6 cm of dilation is achieved, standards of active phase progress should not be applied. |
1B |
Strong recommendation, moderate quality evidence |
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Cesarean delivery for active phase arrest in the first stage of labor should be reserved for women at or beyond 6 cm of dilation with ruptured membranes who fail to progress despite 4 hours of adequate uterine activity, or at least 6 hours of oxytocin administration with inadequate uterine activity and no cervical change. |
1B |
Strong recommendation, moderate quality evidence |
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Second stage of labor |
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A specific absolute maximum length of time spent in the second stage of labor beyond which all women should undergo operative delivery has not been identified. |
1C |
Strong recommendation, low quality evidence |
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Before diagnosing arrest of labor in the second stage, if the maternal and fetal conditions permit, allow for the following:
Longer durations may be appropriate on an individualized basis (eg, with the use of epidural analgesia or with fetal malposition) as long as progress is being documented. (1B) |
1B |
Strong recommendation, moderate quality evidence |
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Operative vaginal delivery in the second stage of labor by experienced and well trained physicians should be considered a safe, acceptable alternative to cesarean delivery. Training in, and ongoing maintenance of, practical skills related to operative vaginal delivery should be encouraged. |
1B |
Strong recommendation, moderate quality evidence |
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Manual rotation of the fetal occiput in the setting of fetal malposition in the second stage of labor is a reasonable intervention to consider before moving to operative vaginal delivery or cesarean delivery. In order to safely prevent cesarean deliveries in the setting of malposition, it is important to assess the fetal position in the second stage of labor, particularly in the setting of abnormal fetal descent. |
1B |
Strong recommendation, moderate quality evidence |
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Fetal heart rate monitoring |
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Amnioinfusion for repetitive variable fetal heart rate decelerations may safely reduce the rate of cesarean delivery. |
1A |
Strong recommendation, high quality evidence |
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Scalp stimulation can be used as a means of assessing fetal acid–base status when abnormal or indeterminate (formerly, nonreassuring) fetal heart patterns (eg, minimal variability) are present and is a safe alternative to cesarean delivery in this setting. |
1C |
Strong recommendation, low quality evidence |
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Induction of labor |
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Before 41 0/7 weeks of gestation, induction of labor generally should be performed based on maternal and fetal medical indications. Inductions at 41 0/7 weeks of gestation and beyond should be performed to reduce the risk of cesarean delivery and the risk of perinatal morbidity and mortality. |
1A |
Strong recommendation, high quality evidence |
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Cervical ripening methods should be used when labor is induced in women with an unfavorable cervix. |
1B |
Strong recommendation, moderate quality evidence |
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If the maternal and fetal status allow, cesarean deliveries for failed induction of labor in the latent phase can be avoided by allowing longer durations of the latent phase (up to 24 hours or longer) and requiring that oxytocin be administered for at least 12–18 hours after membrane rupture before deeming the induction a failure. |
1B |
Strong recommendation, moderate quality evidence |
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Fetal malpresentation |
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Fetal presentation should be assessed and documented beginning at 36 0/7 weeks of gestation to allow for external cephalic version to be offered. |
1C |
Strong recommendation, low quality evidence |
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Suspected fetal macrosomia |
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Cesarean delivery to avoid potential birth trauma should be limited to estimated fetal weights of at least 5,000 g in women without diabetes and at least 4,500 g in women with diabetes. The prevalence of birth weight of 5,000 g or more is rare, and patients should be counseled that estimates of fetal weight, particularly late in gestation, are imprecise. |
2C |
Weak recommendation, low quality evidence |
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Excessive maternal weight gain |
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Women should be counseled about the IOM maternal weight guidelines in an attempt to avoid excessive weight gain. |
1B |
Strong recommendation, moderate quality evidence |
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Twin gestations |
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Perinatal outcomes for twin gestations in which the first twin is in cephalic presentation are not improved by cesarean delivery. Thus, women with either cephalic/cephalic-presenting twins or cephalic/noncephalic presenting twins should be counseled to attempt vaginal delivery. |
1B |
Strong recommendation, moderate quality evidence |
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Other |
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Individuals, organizations, and governing bodies should work to ensure that research is conducted to provide a better knowledge base to guide decisions regarding cesarean delivery and to encourage policy changes that safely lower the rate of primary cesarean delivery. |
1C |
Strong recommendation, low quality evidence |
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PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids
A reA review by EMA’s safety committee (PRAC) has confirmed that 5-mg ulipristal acetate (Esmya and generic medicines) used for the treatment of symptoms of uterine fibroids can cause liver injury, including the need for liver transplantation. The PRAC has therPRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroidsePRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroidsfore recommended the revocation of the marketing authorisations of these medicines. The PRAC considered all the available evidence in its review, including reported cases of serious liver injury. Patient and healthcare professional representatives, including experts in gynaecology, were also consulted. Since it was not possible to identify which patients were most at risk or measures that could reduce the risk, the PRAC concluded that the risks of these medicines outweighed their benefits and that they should not be marketed in the EU. The use of 5-mg ulipristal acetate medicines for uterine fibroids had already been suspended as a precautionary measure while awaiting the outcome of this review. Ulipristal acetate is also authorised as a single-dose medicine for emergency contraception. This recommendation does not affect the single-dose ulipristal acetate emergency contraceptive (ellaOne and other trade names) and there is no concern about liver injury with these medicines. The PRAC recommendation will now be forwarded to EMA’s human medicines committee (CHMP), which will adopt the Agency’s opinion.view by EMA’s safety committee (PRAC) has confirmed that 5-mg ulipristal acetate (Esmya and generic medicines) used for the treatment of symptoms of uterine fibroids can cause liver injury, including the need for liver transplantation. The PRAC has therefore recommended the revocation of the marketing authorisations of these medicines. The PRAC considered all the available evidence in its review, including reported cases of serious liver injury. Patient and healthcare professional representatives, including experts in gynaecology, were also consulted. Since it was not possible to identify which patients were most at risk or measures that could reduce the risk, the PRAC concluded that the risks of these medicines outweighed their benefits and that they should not be marketed in the EU. The use of 5-mg ulipristal acetate medicines for uterine fibroids had already been suspended as a precautionary measure while awaiting the outcome of this review. Ulipristal acetate is also authorised as a single-dose medicine for emergency contraception. This recommendation does not affect the single-dose ulipristal acetate emergency contraceptive (ellaOne and other trade names) and there is no concern about liver injury with these medicines. The PRAC recommendation will now be forwarded to EMA’s human medicines committee (CHMP), which will adopt the Agency’s opinion.
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Guideline Update on Pelvic Organ Prolapse
Obstet Gynecol; ePub 2017 Nov; Tulikangas, et al
November 6, 2017
The American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) have issued updated clinical management guidelines that highlight recent systematic review evidence on the use of biologic and synthetic mesh grafts in the repair of anterior pelvic organ prolapse (POP). The joint document reviews information on the current understating of POP in women and outlines guidelines for diagnosis and management. Updated (Level A) recommendations include:
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Uterosacral and sacrospinous ligament suspension for apical POP with native tissue are equally effective surgical treatments of POP, with comparable anatomic, functional, and adverse outcomes.
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The use of synthetic mesh or biologic grafts in transvaginal repair of posterior vaginal wall prolapse does not improve outcomes.
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Compared with native tissue anterior repair, polypropylene mesh augmentation of anterior vaginal wall prolapse repair improved anatomic and some subjective outcomes but is associated with increased morbidity.
Citation:
Pelvic organ prolapse. Practice Bulletin No. 185. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2017;130:e234–50.
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Vaginal birth after cesarean delivery.
Practice Bulletin No. 184. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2017:130:e217–33.
Most women with 1 previous cesarean delivery with a low-transverse incision are candidates for and should be counseled about and offered trial of labor after cesarean delivery (TOLAC), a planned attempt to deliver vaginally after a previous cesarean delivery, regardless of the outcome. This according to new clinical management guidelines from the American College of Obstetricians and Gynecologists (ACOG) which help clinicians determine who is an appropriate candidate for TOLAC after assessing the likelihood of a vaginal birth after cesarean delivery (VBAC) as well as individual risks. Among the ACOG recommendations:
Level A:
- Most women with 1 previous cesarean delivery with a low-transverse incision are candidates for and should be counseled about and offered TOLAC.
- Misoprostol should not be used for cervical ripening or labor induction in patients at term who have had a cesarean delivery or major uterine surgery.
- Epidural analgesia for labor may be used as part of TOLAC.
Level B:
- Those at high risk of uterine rupture and those in whom vaginal delivery is otherwise contraindicated are not generally candidates for planned TOLAC.
- Given the overall data, it is reasonable to consider women with 2 previous low-transverse cesarean deliveries to be candidates for TOLAC and to counsel them based on the combination of other factors that affect their probability of achieving a successful VBAC.
- Women with 1 previous cesarean delivery with an unknown uterine scar type may be candidates for TOLAC, unless there is a high clinical suspicion of a previous classical uterine incision such as cesarean delivery performed at an extremely preterm gestation age.
- Women with 1 previous cesarean delivery with a low-transverse incision, who are otherwise appropriate candidates for twin vaginal delivery, are considered candidates for TOLAC.
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Professional standards: Interactions between obstetricians and gynecologists and other health professionals
The obstetrician and gynecologist should not only maintain clinical competence, but should also work collaboratively with other health professionals to reduce medical error, increase patients’ safety, minimize overuse of healthcare resources, and optimize the outcomes of care. ·
The obstetrician and gynecologist should:·
- Ensure that interactions with other health professionals are always respectful and considerate and recognize the skill sets of the other health professionals.
- Communicate truthfully and sensitively with all other health professionals with whom he/she interacts.
- Not discriminate when interacting with other health professionals on the grounds of age, race, color, ancestry, place of origin, political belief, religion, marital status, physical or mental disability, sex, sexual orientation or unrelated criminal convictions.
- Respect the personal boundaries of others including, but not limited to, refraining from making unwanted physical or emotional approaches, protecting personal information, and respecting individual workspace.
- Treat patients and families with respect and dignity in all discussions with other members of the healthcare team.
- Not criticize any other health professional in an untruthful, misleading or deceptive manner to patients or other health professionals or the general public
- Appropriately acknowledge contributions made by other health professionals to research projects and to other publications.
- Communicate and cooperate with other health professionals to the full extent necessary to serve the best interests of the patient.
- Maintain an open and professional relationship with other health professionals by: (1) clear communication, with due regard to privacy and confidentiality; and (2) cooperation, collaboration, and teamwork (to reduce medical error, increase patients’ safety, minimize overuse of resources and optimize the outcomes of care).
- Not engage in exploitative relationships with other health professionals for emotional, financial, research, educational or sexual purpose.
- Provide ethical and professional support to other health professionals.
- Report professional misconduct and insufficiently-skilled practice to the appropriate authorities, respecting the need to avoid unjustly discrediting the reputation of other health professionals. The doctor should also facilitate professional help and care for the other health professional if it is indicated.
- Act with scrupulous fairness when required to act as an expert commenting on the professional practice and behavior of another health professional.
- Advocate for the rights and security of each health professional to practice their profession within the law and with protection from interference or intimidation from any source.
- Not compel another health professional to act contrary to their moral conviction or religious belief, except as required by law
- Promote professional behavior and help to resolve disputes between health professionals.
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FIGO Criminilazation statement ( 2017)
Criminal Proceedings for Medical Errors in Obstetrics and Gynecology Background
1. “Criminalization of medical errors” refers here not only to formal criminal charges laid by government authorities but also to threats to bring criminal charges made by individuals or government authorities.
2. While exceedingly rare, there has been a perceived increase in criminalization of medical errors in many countries.
3. A crime is an act, or omission to fulfil a duty to act, that causes harm not only to another but that also harms or gravely offends the wider community, justifying punishment of the offender rather than simply compensation to an injured individual.
4. Criminalization requires two conditions to be met: (a) a harmful act or omission constituting a gross deviation from a legally required standard of care, often displayed in a pattern of conduct; and (b) a culpable state of mind, showing that the harmful act or omission was undertaken purposely to cause harm, knowing that it might cause harm, or recklessly regarding whether it would risk causing harm. The legally required standard of care must take into account limits on resources that are beyond the control of the obstetrician-gynecologist.
5. Adverse outcomes occur not uncommonly in obstetrics and gynecology, despite focused and sustained adherence to processes to ensure patient safety and quality of care. An adverse outcome, no matter how severe, does not in itself justify the conclusion that negligence has occurred, because the vast majority of adverse outcomes do not result from deviations from a standard of care, but from current scientific and clinical limitations of obstetric and gynecologic practice. The burden of proof therefore is on the individual or governmental authority that claims that an alleged medical error should be liable to punishment under criminal law.
6. Unjustified criminalization of medical errors, such as through charges of manslaughter, criminal negligence causing death or serious bodily harm, or assault, causes disproportionate harm to obstetrician-gynecologists’ reputations and self-confidence, and to patients and societies dependent on access to their professional services.
Ethical Framework
1. The obstetrician-gynecologist has the professional responsibility to adhere to processes designed to ensure patient safety and quality of care.
2. Leaders in obstetrics and gynecology have the professional responsibility to create an organizational culture of professionalism that provides oversight of processes of patient safety and quality of care. 3. The ethical principle of justice precludes criminal proceedings or threats of criminal proceedings when there is no prima facie evidence that the criteria for a crime have been met. 4. The ethical principle of justice precludes issue of an arrest warrant, arrest itself, or confiscation of travel documents, when there is no prima facie evidence that the criteria for a crime have been met.
Recommendations
1. Obstetrician-gynecologists and leaders in the specialty should observe the wellrecognized, internationally accepted professional responsibility to enhance patient safety and quality of care, in order to minimize medical errors.
2. Obstetrician-gynecologists and their professional associations (where they exist) should advocate for reform of criminal law to prevent prosecutorial abuses when adverse outcomes occur.
3. To achieve this reform, obstetrician-gynecologists and their professional associations (where they exist) should advocate for the creation of mandatory pre-trial review of criminal charges alleging medical error, conducted by government–supported independent peer-review committees, whose reports would be available to parties in related criminal proceedings. This pre-trial review must involve the obstetrician-gynecologist concerned.
4. Obstetrician-gynecologists and their professional associations (where they exist) should advocate for the legal prohibition of issue of an arrest warrant, arrest itself, confiscation of travel documents, or other measures when there is no prima facie evidence that the criteria for an alleged crime have been met.
5. Obstetrician-gynecolgists and their professional associations (where they exist) should support obstetrician-gynecologists to bring civil proceedings, such as for malicious prosecution or defamation, against individuals or governmental authorities that bring or threaten to bring charges when they are groundless, i.e., there is no prima facie evidence that the criteria for an alleged crime have been met. Because of the serious consequences for the individual obstetriciangynecologist and the medical profession, timely and fair compensation should be awarded.
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Resolution on ‘Conscientious Objection’
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ACOG Committee Opinion No. 774 Summary: Opportunistic Salpingectomy as a Strategy for Epithelial Ovarian Cancer Prevention
Recommendations and Conclusions
Opportunistic salpingectomy is the removal of the fallopian tubes for the primary prevention of ovarian cancer in a woman already undergoing pelvic surgery for another indication. Based on the current understanding of ovarian carcinogenesis and the safety of salpingectomy, the American College of Obstetricians and Gynecologists supports the following recommendations and conclusions:
- Salpingectomy at the time of hysterectomy or as a means of tubal sterilization appears to be safe and does not increase the risk of complications such as blood transfusions, readmissions, and postoperative complications, infections, or fever compared with hysterectomy alone or tubal ligation.
- Ovarian function does not appear to be affected by salpingectomy at the time of hysterectomy based on surrogate serum markers or response to in vitro fertilization.
- The surgeon and patient should discuss the potential benefits of the removal of the fallopian tubes during a hysterectomy in women at population risk of ovarian cancer who are not having an oophorectomy.
- Counseling women who are undergoing routine pelvic surgery about the risks and benefits of salpingectomy should include an informed consent discussion about the role of oophorectomy and bilateral salpingo-oophorectomy.
- Although data are limited, postpartum salpingectomy and salpingectomy at time of cesarean delivery appear feasible and safe.
- The risks and benefits of salpingectomy should be discussed with patients who desire permanent sterilization.
- Plans to perform an opportunistic salpingectomy should not alter the intended route of hysterectomy.