Evaluating the effectiveness of lateral postural management for breech presentation: study protocol for a randomized controlled trial (BRLT study).

BACKGROUND: Breech presentation is observed in 3-4% at term of pregnancy and is one of the leading causes of cesarean section. There is no established treatment for breech presentation before 36 weeks. A retrospective cohort study was conducted to demonstrate that the lateral position is effective for breech presentation. However, there are no randomized controlled trials evaluating lateral position management for breech presentation. Here, we described the methodology of a randomized controlled trial of a cephalic version for breech presentation in the third trimester by lateral postural management (BRLT study). METHODS: The BRLT study is an open-label, randomized controlled trial with two parallel groups allocated in a 1:1 ratio to examine the lateral position management for breech presentation, as compared with expectant management care. An academic hospital in Japan will enroll 200 patients diagnosed with a breech presentation by ultrasonography between 28 + 0 weeks and 30 + 0 weeks. Participants in the intervention group will be instructed to lie on their right sides for 15 min three times per day if the fetal back was on the left side or lie on their left sides if the fetal back was on the right side. The instruction will be given every 2 weeks after confirmation of fetal position, and the lateral position will be instructed until the cephalic version, and after the cephalic version, the reverse lateral position will be instructed until delivery. The primary outcome is cephalic presentation at term. The secondary outcomes are cesarean delivery, cephalic presentation 2, 4, and 6 weeks after the instruction, and at delivery, recurrent breech presentation after cephalic version, and adverse effects. DISCUSSION: This trial will answer whether the lateral positioning technique is effective in treating breech presentation and, depending on the results, may provide a very simple, less painful, and safe option for treating breech presentation before 36 weeks, and it may impact breech presentation treatment. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000043613. Registered on 15 March 2021 https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049800 .

Spontaneous cephalic version and risk factors for persistent breech presentation: a longitudinal retrospective cohort study.

AIMS: To address the rate of spontaneous version in breech presentation until term and explore the risk factors for persistent breech presentation diagnosed by the second-trimester ultrasound examination. METHODS: This is a retrospective cohort study of pregnant women with a singleton pregnancy who had their ultrasound examination conducted at the time of 22-26 weeks of gestation in the Guangzhou Women and Children's Medical Center. Cox regressions were applied to determine the strength of association between selected risk factors and persistent breech presentation. RESULTS: Among 25,313 pregnant women eligible for analysis, the prevalence of breech presentation was 36.8% (9,306/25,313) at 22-26 weeks of gestation, 4.2% (376/8,876) of which would remain in the breech presentation at the onset of labor (adjusted odds ratio [aOR], 0.39, 95% confidence interval [CI], 0.17-0.88). Multiparity (aOR, 0.39, 95% CI, 0.30-0.52) and longer gestational weeks at delivery (aOR, 0.50, 95% CI, 0.44-0.56) were associated with a lower risk of persistent breech presentation (PBP). Female fetus, lateral or fundal placenta, and known uterine malformation was each associated with an increased odd of 1.4 (aOR, 95% CI, 1.11-1.70), 2.4 (aOR, 95% CI,1.50-3.73), 3.1 (aOR, 95% CI, 1.71-5.53) and 8.7 (aOR, 95% CI, 3.84-19.84) times in the persistent breech presentation, respectively. CONCLUSION: The prevalence of the breech presentation was 36.8% between 22 and 26 weeks of gestation, and approximately 4% would have been in the persistent breech presentation until the onset of labor. Higher educational attainment, multiparity and longer gestational weeks at delivery were significantly decreasing the risk of persistent breech presentation. While the pregnant women with age >40 years, female fetus, lateral or fundal placenta and known uterine malformation were associated increased risk of persistent breech presentation.

Manipulative Reduction for Abnormal Uterine Inclination in Vaginal Delivery.

OBJECTIVE: To investigate the manipulative reduction in abnormal uterine inclination in vaginal delivery. METHODS: With the independently developed uterine inclination surveyor, 40 primiparas with abnormal uterine inclination were randomly divided into two groups: treatment group (Group A, 20 cases) and control group (Group B, 20 cases). The general condition of the primipara, the labor stages, the changes in uterine inclination after treatment, postpartum hemorrhage at 2 hours, and the general condition of fetuses were observed to study the therapeutic value of manual reduction in abnormal uterine inclination. RESULT: In the control group, one uterine inclination was not corrected with the change in labor process, and the pregnancy was terminated due to stagnation of the active phase. In the first stage of labor, the time spent in the treatment group (393.4 ± 31.3 mins) was significantly lower than that in the control group (440.7 ± 34.9 mins) (P = 0.001). Compared with the control group (49.8 ± 6.5 mins), the treatment group (42.6 ± 7.2 mins) also exhibited a significantly shortened second stage of labor (P = 0.02). Sixteen cases (16/20) in the treatment group returned to normal after manual reduction, and 9 cases (9/20) in the control group returned to normal with the progression of natural labor. Manual reduction could be used as an option to treat abnormal uterine inclination (P = 0.01). There was no significant difference in the third stage of labor (P = 0.2), 2-hour postpartum hemorrhage (P = 0.35), Apgar score (P = 0.64), or body weight (P = 0.76) between the two groups. CONCLUSION: Manual reduction in the treatment of abnormal uterine inclination has obvious effects, shortens the birth process, and is safe for the fetus.

External cephalic version of the non-cephalic presenting twin: a systematic review.

OBJECTIVE: Decreasing the primary cesarean delivery rate and associated maternal and fetal complications is a priority for obstetric care providers. External cephalic version (ECV) is a procedure recommended for women with singleton pregnancies where the fetus is malpresenting to avoid vaginal breech delivery, which is inherently riskier than cesarean delivery. However, little is known about this procedure in the context of twin gestations. Scheduled cesarean delivery is instead recommended for women with twin gestations where the presenting twin is not cephalic. Our aim is to evaluate the safety and efficacy of ECV in the setting of twin pregnancy where the presenting twin is not cephalic. We also present two patients with twin pregnancy at our institution that attempted ECV. DATA SOURCES: A systematic review of the following electronic databases was performed, searching from their inception until September 2019: Pubmed, Ovid, Scopus, and clinicaltrials.gov. STUDY ELIGIBILITY CRITERIA: All reported cases of ECV for a non-cephalic presenting twin were included. Studies were excluded if patients had contraindications to vaginal delivery and if they described ECV of the second twin only. Maternal demographics, procedure details, and outcomes data were collected. STUDY APPRAISAL AND SYNTHESIS METHODS: The primary outcome was a successful version of the presenting twin to the cephalic presentation following ECV. Statistical analysis involved calculating means, standard deviations, frequencies and percentages as appropriate. RESULTS: Two case reports and one case series, totaling 22 patients, met inclusion criteria. Two additional patients attempted ECV at our institution. One completed ECV (for a total of 23 patients) while the other did not. This patient consented for ECV as Twin A was noted to be breeched upon presentation to labor and delivery but after receiving regional anesthesia, twin A was cephalic. No randomized controlled trials were identified. All were dichorionic pregnancies. Successful ECV of twin A occurred in 57% (13/23) of women and 48% (11/23) had a successful vaginal delivery. The majority were performed using regional anesthesia and a uterine relaxant (20/23). No serious adverse events occurred in any of the reports. CONCLUSIONS: ECV is insufficiently studied in twin pregnancy. Based on very limited data, it appears feasible to turn the non-cephalic presenting twin. Additional randomized controlled trials are needed to further evaluate the safety and efficacy of this procedure for a non-cephalic presenting twin.

Risk factors and outcomes of abnormal bleeding after external cephalic version.

OBJECTIVES: To present the consequences of and risk factors for abnormal bleeding after ECV (external cephalic version). METHODS: We conducted a retrospective chart review at a single center in Japan. Abnormal bleeding was defined as vaginal bleeding and/or intrauterine hemorrhage. We descriptively assessed birth outcomes among women with abnormal bleeding, and investigated the risk factors using a logistic regression analysis. RESULTS: Of 477 women who received ECV, 39 (8.2%) showed abnormal bleeding, including 16 (3.4%) with intrauterine hemorrhage. Of the 16 women with intrauterine hemorrhage, 14 required emergency cesarean section; none experienced placental abruption, a low Apgar score at 5 min (<7), or low umbilical cord artery pH (<7.1). Among 23 women who had vaginal bleeding without intrauterine hemorrhage, four cases underwent emergency cesarean section and one case of vaginal delivery involved placental abruption. The risk of abnormal bleeding was higher in women with a maximum vertical pocket (MVP) of <40 mm in comparison to those with an MVP of >50 mm (adjusted odds ratio [OR]: 3.48, 95% confidence interval [CI]: 1.23-9.90), as was higher in women with unsuccessful ECV than in those with successful ECV (aOR: 4.54, 95% CI: 1.95-10.6). CONCLUSIONS: A certain number of women who underwent ECV had abnormal bleeding, including vaginal bleeding and/or intrauterine hemorrhage, many of them resulted in emergency cesarean section. Although all of cases with abnormal bleeding had good birth outcomes, one case of vaginal bleeding was accompanied by placental abruption. Small amniotic fluid volume and unsuccessful ECV are risk factors for abnormal bleeding.

Patient opinion of analgesia during external cephalic version at term in singleton pregnancy.

To assess the opinion and the level of satisfaction of patients concerning analgesia during external cephalic version (ECV), we present the results of a survey of 120 women undergoing ECV at term during a randomised controlled trial (July 2012 to February 2013) comparing remifentanil and nitrous oxide. Overall, 110 (91.7%) women said they would repeat the procedure and 111 (92.5%) that they would recommend it to another pregnant woman, with no significant differences by type of analgesia. The administration and sense of comfort were rated better in the remifentanil group (p < .01). In conclusion, the use of analgesia during ECV is associated with a high rate of willingness among women to repeat the procedure and recommend it to other pregnant women.Impact statementWhat is already known on this subject? ECV is commonly a painful manoeuvre for the woman. This pain triggers maternal reactive abdominal muscle contraction and involuntary abdominal tensing, reducing the likelihood of successful version and causing some women to reject the technique.What do the results of this study add? The use of analgesia during ECV is associated with a high rate of willingness among women to repeat the procedure and recommend it to other pregnant women. The sense of comfort during ECV was also significantly better in the remifentanil group, probably because of its greater analgesic power and greater comfort during its administration.What are the implications of these findings for clinical practice and/or further research? ECV should be carried out under analgesia, when available, not only to decrease pain but also to encourage wider adoption of the technique and enable more women to benefit from it.

External Cephalic Version: Is it an Effective and Safe Procedure?

External cephalic version (ECV) is an effective procedure for reducing the number of cesarean sections. To date, there is no video publication showing the methodology of this procedure. The main objective is to show how to perform ECV with a specific protocol with tocolysis before the procedure and analgesia. Moreover, we describe and analyze the factors associated with successful ECV, and also compare to deliveries in the general pregnant population. A retrospective and descriptive analysis of ECV carried out at the Hospital Clinico Universitario Virgen de la Arrixaca in Murcia (Spain) between 1/1/2014 and 12/31/2018 was assessed. The latest data available of labor deliveries in the local center, which is the biggest maternity department in Spain, were from 2018. 320 patients were recruited and 3 pregnant women were lost during the study. ECV was carried out at 37±3 weeks gestation. ECV was successful in 82.5% (N=264). 19 complications were reported (5.9%): 8 vaginal bleeding (2.5%), 9 fetal bradycardia (2.8%), 1 preterm rupture of membranes (0.3%) and 1 cord prolapse (0.3%). A previous vaginal delivery increases the success rate of ECV ORadjusted=3.03 (1.62-5.68). Maternal Body Mass Index (BMI) affects the success of ECV ORadjusted=0.94 (0.89-0.99). Patients with BMI>40 kg/m2 have an ORadjusted=0.09 (0.009-0.89) compared with those with BMI <25 kg/m2. If ECV was successful, the cesarean delivery index is 22.2% (17.5-27.6%), the eutocic delivery index is 52.1% (46.1-58.1%) and the instrumented vaginal delivery index is 25.7% (20.7-31.2%). There are no differences in cesarean and eutocic delivery indexes after successful ECV. However, a successful ECV is associated with a 6.29% increase in the instrumented delivery rate (OR=1.63). ECV is an effective procedure to reduce the number of cesarean sections for breech presentations. Maternal BMI and previous vaginal delivery are associated with ECV success. Successful ECV does not modify the usual delivery pattern.

A randomised controlled trial to assess the feasibility of utilising virtual reality to facilitate analgesia during external cephalic version.

External cephalic version (ECV) is associated with a moderate degree of pain. Virtual reality (VR) is a technology that has shown promise in offering procedural analgesia. We undertook a clinical pilot to assess the viability of VR to reduce pain during ECV. In an open randomised controlled trial (RCT), we randomised 50 women to either VR or standard care each (25 per group). Women receiving VR were administered VR content (Skylights) via a headset. Pre- and post-procedural measures of pain, anxiety, device experience and vital signs were measured. There were no significant differences between groups (VR/no VR) in pain scores (60.68 vs 49.76; p = 0.2), ECV success rates (80% vs 76%; p = 0.7) or anxiety levels. The women receiving VR had a significantly higher anticipation of pain pre-procedurally (70.0 vs 50.0; p = 0.03). 20 (80%) of the VR women indicated that they would use VR again and 22 (88%) indicated they would recommend it to a friend having ECV. There were no significant differences between groups for side effects encountered or changes in vital signs. We have shown that using VR during ECV is feasible and appears safe. Our results inform the design of future RCTs.

Delivery outcomes in subsequent pregnancy following primary breech cesarean delivery: a retrospective cohort study.

Background: Women may be unaware of the potential impact on subsequent deliveries of the decision to undergo primary breech cesarean (PBC) delivery rather than attempt external cephalic version (ECV). We investigated cesarean delivery rates and adverse maternal outcomes in the subsequent delivery following management of breech presentation by ECV versus PBC.Methods: This retrospective study identified women who delivered subsequent to breech presentation managed by attempted ECV or PBC. We assessed cesarean delivery rates and adverse maternal outcomes including hemorrhage, placental complications, infection, and obstetric complications in the subsequent delivery following attempted ECV versus PBC.Results: We identified 307 women who had attempted ECV and 508 with PBC in the index breech pregnancy. Following attempted ECV, 47 (15.3%) women had cesarean delivery in the subsequent pregnancy versus 246 (48.4%) following PBC, adjusted OR 0.24, 95% CI 0.16-0.35 for subsequent cesarean delivery after attempted ECV in the index pregnancy. The frequency of composite adverse outcomes related to cesarean delivery was 30 (9.8%) following attempted ECV versus 104 (20.5%) after PBC, p < .0001. The frequency of composite severe adverse maternal outcome was similar following attempted ECV 25 (8.8%) versus PBC 59 (11.9%).Conclusions: The current study suggests that attempted external cephalic version was associated with a five-fold decrease risk to undergo cesarean in the subsequent delivery and a significantly decreased frequency of composite adverse outcomes related to cesarean delivery in the subsequent delivery.

Comparison of Nitroglycerin and Terbutaline for External Cephalic Version in Women Who Received Neuraxial Anesthesia: A Retrospective Analysis.

External cephalic version is a technique that decreases the need for cesarean delivery in patients with breech presentation. Several techniques exist to increase the success of external cephalic version; however, there are no studies comparing different tocolytics in patients who also received neuraxial anesthesia. We, therefore, performed a review of 198 patients who presented for external cephalic version and compared their success rates based on the tocolytic medication utilized. The external cephalic version success rate for patients who received terbutaline was significantly higher than for those who received nitroglycerin (N [%]: 57 [65.6] terbutaline group versus 40 [36.0] nitroglycerin group; P < .001).

The effect of transient fetal bradycardia and other heart rate changes during and after external cephalic version on perinatal outcomes.

OBJECTIVES: To evaluate the effect of transient fetal bradycardia and other heart rate changes during and after external cephalic version (ECV) on perinatal outcomes. To determine factors associated with a higher risk of occurrence of transient fetal bradycardia during and after ECV. STUDY DESIGN: Prospective study in 286 women after the 36th week of gestation with a fetus in breech presentation who have undergone an ECV attempt. The study analyses the incidence of transient fetal bradycardia during and immediately after ECV, the time interval to complete adjustment of fetal bradycardia, the factors associated with the occurrence of transient fetal bradycardia, cardiotocography (CTG) changes after ECV and perinatal outcomes. All the data were statistically analyzed. RESULTS: The ECV was successful in 51 % (146/286). Transient fetal bradycardia occurred during and after ECV in 81 cases (28.3 %). A successful version was a factor significantly associated with fetal bradycardia (54; 37.0 % versus 27; 19.3 %; p < 0.01). Clinically significant hypotension of the mother was accompanied by transient fetal bradycardia in 12 cases (4.2 %). After the successful ECV there was no significant difference in the percentage of vaginal deliveries between subgroups with and without transient fetal bradycardia (85.2 % versus 83.7 %; p = 1.00). Nor in occurrence of acute fetal distress during labor (18.5 % versus 15.6 %; p = 0.65). In cases of a successful ECV transient CTG changes after ECV had no effect on the incidence of acute fetal distress during labor (23.5 % versus 15.7 %; p = 0.49). CONCLUSIONS: Transient fetal bradycardia and other heart rate changes during and immediately after ECV was not associated with a higher incidence of acute fetal distress during labor and did not affect perinatal outcomes. Higher occurrence of transient bradycardia after ECV was associated only with successful ECV. Transient hypotension of the mother as one of the causes of transient fetal bradycardia during ECV should be considered.

Maternal and perinatal outcomes in external cephalic version: prognostic factors for the success of the technique.

Background We aimed to analyze the success rate of external cephalic version (ECV) for breech presentations performed in our center between March 2011 and March 2016. We evaluated factors related to a successful ECV, delivery mode, complications and newborn status after ECV. Methods Analysis of assembled data of 327 consecutive ECVs in the third trimester was done. Results The total success rate was 56.6%. After a successful ECV, 85.9% of the fetuses were delivered vaginally. Logistic regression analysis of background factors leading to a successful ECV showed that tocolysis with ritodrine and anterior placenta were each significantly correlated with the rate of successful version. No severe complications were registered during the ECVs, and all babies had normal Apgar scores at delivery. Conclusion These findings suggest that attempting an ECV in breech presentations, once or even twice, seems to be an appropriate management given that a successful ECV decreases the rate of cesarean section in this group of patients and by doing so, it might also decrease the risk of cesarean sections in future pregnancies.

[Manual rotation in occiput posterior position: A systematic review in 2019]. / Rotation manuelle des variétés postérieures : état des lieux de la littérature en 2019.

OBJECTIVE: The aim of our study was to evaluate the safety and the benefits of manual rotation in the management of Occiput-posterior positions in 2019. METHODS: A systematic review of literature was performed using the MEDLINE and COCHRANE LIBRARY databases, in order to identify articles concerning maternal and neonatal outcomes after a manual rotation, through January 2019. Information on study characteristics (review, author, year of publication), population, objectives and main neonatal and maternal outcomes were extracted. RESULTS: A total of 51 articles were identified and 12 articles were selected for the systematic review. The rate of successful manual rotation were about 47 to 90%. There were more success if systematic manual rotation, multiparity, engagement, spontaneous labour and maternal age<35. The 2nd stage of labour was shorter after an attempt of manual rotation. The randomised controlled trials did not find any statistical difference concerning operative deliveries or neonatal and maternal outcomes. CONCLUSION: The manual rotation is an obstetrical manoeuvre which must be regulated and only practiced by trained operators. Currently, the state of science is not sufficient to recommend the manual rotation as a systematic practice in 2019.

Success rates of early versus late initiation of external cephalic version.

OBJECTIVE: To determine optimum timing of external cephalic version (ECV). METHODS: A retrospective cohort study was conducted at a tertiary hospital in Israel between February 1, 2016, and July 1, 2017. Healthy primiparous women with breech presentation were offered either early ECV (35-36 weeks; n=54) or late ECV (37-38 weeks; n=106). Group assignment was according to the patient's preference and physician availability. The primary outcome was the rate of cephalic presentation at delivery. Secondary outcomes included rate of cesarean delivery, presentation of fetus after the first and last ECVs, and serious fetal complications. RESULTS: The incidence of undergoing more than two ECV attempts was 18.5% in the early ECV group and 5.6% in the late ECV group (P=0.039). The incidence of cephalic presentation after the first ECV was 72.2% in the early ECV group versus 66.0% in the late ECV group (P=0.048). By contrast, no statistically significant between-group differences were found for presentation at delivery or rate of cesarean delivery. The other outcomes were also similar. CONCLUSION: Early initiation of ECV among primiparous women increased the chance of immediate cephalic presentation; however, it had no effect on presentation at delivery or cesarean delivery rate.

The role of manual rotation in avoiding and managing OVD.

Manual rotation (MR) is the most common technique used by accoucheurs who wish to correct malposition of the foetal head to either avoid or facilitate an operative vaginal delivery (OVD). MR can be performed using either a whole-hand or a digital approach. MR should be formally taught and trainees should be assessed for competence, and later, performance should ideally be tracked with statistical control charts. There is paucity of robust evidence evaluating MR relative to the other methods of rotational OVD: rotational forceps (RF) and rotational ventouse (RV). Furthermore, there is little evidence concerning long-term maternal outcomes of rotational OVD. A prospective randomised trial of MR versus either RF or RV is clearly needed, along with a core outcome set for OVD to facilitate comprehensive evaluation programmes that focus on aspects pertaining to women.

The outcomes and risk factors of fetal bradycardia associated with external cephalic version.

OBJECTIVE: The objective of this study is to assess the outcomes and risk factors of fetal bradycardia after external cephalic version (ECV). METHODS: We performed a retrospective study of women who underwent ECV after 35 weeks of gestation in 2010-2016. We assessed the birth outcomes, including umbilical cord artery pH, according to the duration of fetal bradycardia and the risk factors for bradycardia. RESULTS: Among 390 cases, 189 (48.5%) cases showed fetal bradycardia during or immediately after ECV. The duration of fetal bradycardia was <1 min (n = 82, 43.4%), <5 min (n = 168, 88.9%); and <10 min (n = 186, 98.4%). All cases showed a good prognosis. Fetal bradycardia lasting >10 min occurred in three cases; emergency cesarean section was performed in each case, with delivery after 12-4 min of bradycardia. Two of three cases showed low Apgar scores at 5 min, with an umbilical cord arterial pH of <7.1. Lower maternal BMI and a prolonged ECV procedure were significantly associated with bradycardia (p for trend: .016 and .015, respectively). CONCLUSIONS: Fetal bradycardia lasting >10 min after ECV was a risk factor for asphyxia. Thus, delivery should be completed within 10 min after bradycardia. A low maternal BMI and a prolonged ECV procedure were risk factors for bradycardia after ECV.

External cephalic version after previous cesarean section: A cohort study of 100 consecutive attempts.

OBJECTIVE: External cephalic version is commonly not performed in women with a previous cesarean section. Fear of uterine rupture and cesarean section in labor are prominent. The risks, however, of these are unclear. This study aims to document the safety and efficacy of external cephalic version in women with a prior cesarean section in a series of 100 consecutive attempts, and to perform a literature of the existing literature. STUDY DESIGN: This is a retrospective cohort study of prospectively collected data of external cephalic version attempts in women at term with a previous cesarean section, and a literature review of previously published series. External cephalic version was performed by one of 3 experienced operators, with salbutamol tocolysis if appropriate, using ultrasound to visualize the fetal heart and place of fetal parts. RESULTS: 100 women with a prior cesarean section underwent external cephalic version over a 16-year period in one institution. 68% had no previous vaginal delivery. The external cephalic version success rate was 50%, and 30 (63.8%) of these subsequently delivered vaginally. There were no cases of uterine rupture or other complications. A literature review of series containing a total of 549 cases revealed no cases of uterine rupture or perinatal death. CONCLUSIONS: External cephalic version in women with a prior cesarean section is safe but enables a vaginal birth in only about a third of women.

ACOG Committee Opinion No. 745: Mode of Term Singleton Breech Delivery.

There is a trend in the United States to perform cesarean delivery for term singleton fetuses in a breech presentation. The number of practitioners with the skills and experience to perform vaginal breech delivery has decreased. The decision regarding the mode of delivery should consider patient wishes and the experience of the health care provider. Obstetrician-gynecologists and other obstetric care providers should offer external cephalic version as an alternative to planned cesarean for a woman who has a term singleton breech fetus, desires a planned vaginal delivery of a vertex-presenting fetus, and has no contraindications. External cephalic version should be attempted only in settings in which cesarean delivery services are readily available. Planned vaginal delivery of a term singleton breech fetus may be reasonable under hospital-specific protocol guidelines for eligibility and labor management. If a vaginal breech delivery is planned, a detailed informed consent should be documented-including risks that perinatal or neonatal mortality or short-term serious neonatal morbidity may be higher than if a cesarean delivery is planned.

Association Between Attempted External Cephalic Version and Perinatal Morbidity and Mortality.

OBJECTIVE: To examine whether, with fetal malpresentation at term, perinatal morbidity and mortality differ between women who undergo an external cephalic version (ECV) attempt and those who do not and are expectantly managed. METHODS: We conducted a retrospective cohort study of women with nonanomalous singleton gestations in nonvertex presentation delivering at a tertiary care institution from 2006 to 2016. Women undergoing an ECV attempt at 37 weeks of gestation or greater were compared with those with nonvertex fetuses who did not undergo an ECV attempt and delivered at 37 weeks of gestation or greater. The primary outcome was a composite of perinatal morbidity and mortality including stillbirth, neonatal death within 72 hours, Apgar score less than 5 at 5 minutes, umbilical artery pH less than 7.0, base deficit 12 mmol/L or greater, or neonatal therapeutic hypothermia. Secondary outcomes were neonatal intensive care unit admission and neonatal anemia (hemoglobin value less than 13.5 g/dL). Bivariable and multivariable analyses were performed. RESULTS: Of the 4,117 women meeting eligibility criteria, 1,263 (30.7%) attempted ECV; 509 (40.3%) of these attempts resulted in successful versions. In bivariable analyses, women who underwent attempted ECV were more likely to be non-Hispanic white and multiparous and had lower mean body mass indexes. The composite perinatal morbidity and mortality outcome did not differ significantly between women who did and did not undergo attempted ECV (2.9% vs 2.5%, P=.46). The frequencies of neonatal intensive care unit admission (3.6% vs 3.3%, P=.53) and neonatal anemia (1.6% vs 1.2%, P=.36) were also similar. There continued to be no association between ECV attempt and composite perinatal morbidity and mortality outcome after adjustment for potential confounders (adjusted odds ratio 1.02, 95% CI 0.66-1.60). CONCLUSION: Compared with expectant management, an ECV attempt at term is not associated with increased perinatal morbidity or mortality.

The impact of manual rotation of the occiput posterior position on spontaneous vaginal delivery rate: study protocol for a randomized clinical trial (RMOS).

BACKGROUND: The frequency of posterior presentations (occiput of the fetus towards the sacrum of the mother) in labor is approximately 20% and, of this, 5% remain posterior until the end of labor. These posterior presentations are associated with higher rates of cesarean section and instrumental delivery. Manual rotation of a posterior position in order to rotate the fetus to an anterior position has been proposed in order to reduce the rate of instrumental fetal delivery. No randomized study has compared the efficacy of this procedure to expectant management. We therefore propose a monocentric, interventional, randomized, prospective study to show the superiority of vaginal delivery rates using the manual rotation of the posterior position at full dilation over expectant management. METHODS: Ultrasound imaging of the presentation will be performed at full dilation on all the singleton pregnancies for which a clinical suspicion of a posterior position was raised at more than 37 weeks' gestation (WG). In the event of an ultrasound confirming a posterior position, the patient will be randomized into an experimental group (manual rotation) or a control group (expectative management with no rotation). For a power of 90% and the hypothesis that vaginal deliveries will increase by 20%, (10% of patients lost to follow-up) 238 patients will need to be included in the study. The primary endpoint will be the rate of spontaneous vaginal deliveries (expected rate without rotation: 60%). The secondary endpoints will be the rate of fetal extractions (cesarean or instrumental) and the maternal and fetal morbidity and mortality rates. The intent-to-treat study will be conducted over 24 months. Recruitment started in February 2017. To achieve the primary objective, we will perform a test comparing the number of spontaneous vaginal deliveries in the two groups using Pearson's chi-squared test (provided that the conditions for using this test are satisfactory in terms of numbers). In the event that this test cannot be performed, we will use Fisher's exact test. DISCUSSION: Given that the efficacy of manual rotation has not been proven with a high level of evidence, the practice of this technique is not systematically recommended by scholarly societies and is, therefore, rarely performed by obstetric gynecologists. If our hypothesis regarding the superiority of manual rotation is confirmed, our study will help change delivery practices in cases of posterior fetal position. An increase in the rates of vaginal delivery will help decrease the short- and long-term rates of morbidity and mortality following cesarean section. Manual rotation is a simple and effective method with a success rate of almost 90%. Several preliminary studies have shown that manual rotation is associated with reduced rates for fetal extraction and maternal complications: Shaffer has shown that the cesarean section rate is lower in patients for whom a manual rotation is performed successfully (2%) with a 9% rate of cesarean sections when manual rotation is performed versus 41% when it is not performed. Le Ray has shown that manual rotation significantly reduces vaginal delivery rates via fetal extraction (23.2% vs 38.7%, p < 0.01). However, manual rotation is not systematically performed due to the absence of proof of its efficacy in retrospective studies and quasi-experimental before/after studies. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT03009435 . Registered on 30 December 2016.