Translation and validation of the French version of the ObsQoR-10 questionnaire for the evaluation of recovery after delivery: the ObsQoR-10-French.

Background: The Obstetric Quality of Recovery-10 (ObsQoR-10) is a validated tool for assessing the quality of postpartum recovery. This study aimed to validate the French version of the ObsQoR-10 scale (ObsQoR-10-French). Methods: After translating the ObsQoR-10 into French, we conducted a psychometric validation involving internal consistency, convergent validity, construct validity, reliability, responsiveness, scaling properties, acceptability, and feasibility. French women who underwent either a vaginal delivery (spontaneous or induced labour), or an emergency or elective Caesarean section (C-section) were prospectively included. They completed the ObsQoR-10-French before delivery and at 24 h (H24) and 48 h (H48) after delivery. Results: Of the 500 women included, 431 (86%) completed the questionnaire at all three timepoints. A total of 352 women (82%) underwent vaginal delivery (with 228 [53%] experiencing spontaneous labour and 124 [29%] had labour induced), whereas 53 (12%) women underwent an emergency C-section and 26 (6%) an elective C-section. The ObsQoR-10-French demonstrated excellent internal consistency with a Cronbach's coefficient of 0.81, 95% confidence interval 0.78-0.84 at H24. The tool was correlated with an 11-item global health score (P<0.001). Of the list of hypotheses for evaluating the construct validity, 81% were confirmed (negative associations between ObsQoR-10-French and length of labour, hospital stay, the need for a C-section, and the emergency level of the C-section). The Cohen effect size at H24 was 0.58. The intra-class coefficient was 0.90, 95% confidence interval 0.86-0.93 at H24. Conclusion: The ObsQoR-10-French is a valid and reliable psychometric questionnaire, capable of assessing the quality of postpartum recovery in French-speaking populations. Clinical trial registration: NCT04489602.

Physicians' perceptions of the daily use of a handheld ultrasound device in the labor room.

OBJECTIVE: The objective of our study was to describe the perception of physicians who use a handheld ultrasound (US) device in an intensive perinatal care unit. METHODS: We conducted a prospective observational study in the labor ward of an intensive perinatal care unit between November 2021 and May 2022. Obstetrics & Gynecology residents in rotation in our department during this time were recruited as participants in this study. All the participants were provided with a handheld US device Vscan Air™ (GE Healthcare, Zipf, Austria) to use during their normal days and nights practice in labor ward. At the end of their 6 months rotation, participants completed an anonymous surveys about their perceptions of the handheld US device. The survey included questions about the ease of use in clinical situations, the amount of time of initial diagnosis, performances of the device, feasibility to use, and patient's satisfaction with the use of the device. RESULTS: 6 residents in their last year of residency were included. All the participants were satisfied with the device and would like to use it in their future practice. They all agreed that the probe was easy to handle and that the mobile application was easy to use. Image quality was always considered good by the participants and 5/6 of them declared that the handheld US device was always sufficient and did not require any confirmation with a conventional US machine. 5/6 of the participants considered that the handheld US device allowed them to gain time for clinical decision but half of them did not estimate that the use of the handheld US device improved their ability to make a clinical diagnosis. CONCLUSION: Our study suggests that the Vscan Air™ is easy to use, with a good quality image and reduces the amount of time to make a clinical diagnosis. Handheld US device could be useful in the daily practice in maternity hospital.

[Pelvic exam in gynecology and obstetrics: Guidelines for clinical practice]. / Examen pelvien en gynécologie et obstétrique : recommandations pour la pratique clinique.

OBJECTIVE: To provide guidelines for the pelvic clinical exam in gynecology and obstetrics. MATERIAL AND METHODS: A multidisciplinary experts consensus committee of 45 experts was formed, including representatives of patients' associations and users of the health system. The entire guidelines process was conducted independently of any funding. The authors were advised to follow the rules of the Grading of Recommendations Assessment, Development and Evaluation (GRADE®) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasized. METHODS: The committee studied 40 questions within 4 fields for symptomatic or asymptomatic women (emergency conditions, gynecological consultation, gynecological diseases, obstetrics, and pregnancy). Each question was formulated in a PICO (Patients, Intervention, Comparison, Outcome) format and the evidence profiles were produced. The literature review and recommendations were made according to the GRADE® methodology. RESULTS: The experts' synthesis work and the application of the GRADE method resulted in 27 recommendations. Among the formalized recommendations, 17 present a strong agreement, 7 a weak agreement and 3 an expert consensus agreement. Thirteen questions resulted in an absence of recommendation due to lack of evidence in the literature. CONCLUSIONS: The need to perform clinical examination in gynecological and obstetrics patients was specified in 27 pre-defined situations based on scientific evidence. More research is required to investigate the benefit in other cases.

Simulation training for urgent postnatal fetal tracheal balloon removal: Two learning methods.

OBJECTIVE: In fetuses with severe congenital diaphragmatic hernia, fetal endoluminal tracheal occlusion (FETO) with balloon increases survival and reduces morbidity. Balloon removal is often scheduled electively. In urgent cases, in-utero removal is impossible and removal immediately after delivery has to occur, posing risk of death from airway obstruction. Medical staff need training in urgent removal. Ideal training method is unclear; thus, we compared the performance of two groups trained by different methods. METHODS: 24 medical students were randomly assigned to two different learning methods for removal: Group 1 (in-person lecture) and Group 2 (online video). Both methods presented the same information: endoscopic instrument set-up, anatomical landmarks for intubation, and balloon removal. All participants were evaluated using the same instruments and high-fidelity simulator, comparing time for instrument set-up and simulate balloon removal (including removal attempts). RESULTS: Group 1 took significantly less time for instrument set-up compared to Group 2 [62 (30-92) secs vs 81 (57-108) secs; p < 0.01)]; no difference in time to intubate and locate the balloon [75 (50-173) secs vs 92 (32-232) secs; p 0.42], or number of attempts. CONCLUSION: There was no difference between video training and in-person training with regards to the time taken to locate the FETO balloon in the trachea and to simulate its removal.

The role of peak serum estradiol level in the prevention of multiple pregnancies in gonadotropin stimulated intrauterine insemination cycles.

The objective was to assess whether the measurement of serum estradiol (E2) level on trigger day in controlled ovarian stimulation with intrauterine insemination (COS-IUI) cycles helps lower the multiple pregnancy (MP) rate. We performed a unicentric observational study. We included all patients who underwent COS-IUI and had a subsequent clinical pregnancy (CP) between 2011 and 2019. Our main outcome measure was the area under Receiver-Operating Characteristic (ROC) curve. We included 455 clinical pregnancies (CP) obtained from 3387 COS-IUI cycles: 418 singletons, 35 twins, and 2 triplets. The CP, MP, and live birth rates were respectively 13.4%, 8.1% and 10.8%. The area under ROC curve for peak serum E2 was 0.60 (0.52-0.69). The mean E2 level was comparable between singletons and MP (260.1 ± 156.1 pg/mL vs. 293.0 ± 133.4 pg/mL, p = 0.21, respectively). Univariate and multivariate logistic regression analysis showed that E2 level was not predictive of MP rate (aOR: 1.13 (0.93-1.37) and 1.06 (0.85-1.32), respectively). Our study shows that, when strict cancelation criteria based on the woman's age and follicular response on ultrasound are applied, the measurement of peak serum E2 levels does not help reduce the risk of MP in COS-IUI cycles.

Laparotomy-Assisted 2-Port Fetoscopic Repair of Spina Bifida Aperta: Report of a Single-Center Experience in Paris, France.

BACKGROUND: Given the maternal morbidity of open fetal surgery, the development of prenatal fetoscopic repair for spina bifida aperta (SBA) is encouraged. OBJECTIVE: We hereby report the early results from our center, using a laparotomy-assisted CO2-fetoscopic approach. METHODS: This study was conducted in patients with an SBA < T1 and >S1, <26 weeks of gestation, with Chiari II. Fetoscopic repair was performed using 2 operating trocars in the uterus exteriorized through a transverse laparotomy. Endoscopy was performed under humidified and heated CO2 insufflation. Following dissection of the lesion, a 1-layer approach was performed with a muscle/skin flap sutured over a patch of Duragen. Main outcomes were watertight repair at birth and the need for postnatal neurosurgical surgery including shunting within 6 months. RESULTS: Of 87 women assessed for prenatal therapy, 7 were included. Surgery was performed at 24 (23-26) weeks' gestation. There was no fetal demise. Conversion to hysterotomy was not performed, although surgery could not be performed in 1 case because of fetal position. Severe preeclampsia developed postoperatively in 1 case. In the other 6 cases, follow-up was uneventful except for premature rupture membranes which occurred in 3/6 cases at 30, 34, and 36+5 weeks' gestation. Gestational age at delivery was 32 + 5 (31-36 + 5) weeks' gestation. Repair was watertight at birth except in 2 cases which required complementary postnatal surgical repair. Reverse hindbrain herniation during pregnancy was observed in 4/6 cases. In 3/6 cases, shunting was necessary within 6 months after birth. At 12 months, a functional gain of ≥2 metameric levels was observed in 3 cases of the 6 survivors. CONCLUSION: Laparotomy-assisted fetoscopic repair is a reasonable option for women who choose and are eligible for antenatal surgery, both in terms of maternal and perinatal morbidity.

[Fetal aortic valvuloplasty in critical aortic stenosis: indication, technique and postnatal outcomes]. / Valvuloplastie aortique fœtale pour sténose aortique critique : indications, technique et devenir postnatal.

Aortic stenosis is a complex heart disease that involves the aortic valve and the left ventricle. Impairment of the left ventricle, abnormalities in its size, systolic and diastolic function determine the postnatal outcomes in the same way as the aortic valve. In the most severe forms, the left ventricle cannot provide systemic circulation at birth and the physiology is that of hypoplastic left heart syndrome. Fetal aortic valvuloplasty has been developed in the 90s to prevent in utero progression of aortic stenosis to hypoplastic left heart syndrome. In the present article, the most recently reported data about indications, procedure details and postnatal outcomes were reviewed.

Risk factors for operative vaginal delivery after a previous instrumental delivery.

OBJECTIVES: The aim of the present study was to assess factors associated with a repeat operative vaginal delivery (OVD) in women with a previous history of OVD. METHODS: A single-centre retrospective observational study was performed in the maternity ward of the Angers University Hospital between 20/09/2010 and 01/04/2021. All the patients who underwent an OVD between 01/09/2010 and 31/10/2013 (delivery n°1, n = 1215) and who subsequently delivered up to the 01/04/2021 (delivery n°2, n = 652) were included. Multivariate logistic regression was used to assess the risk of subsequent recurrent OVD, adjusted for clinical potential confounder based on univariate analysis. RESULTS: Among the 520/652 (79.7%) patients who delivered vaginally during delivery n°2, 51/520 (9.8%) had undergone a repeated OVD. Gestational age, parity, history of uterine scars, percentage of labour's induction and the duration of labor were similar between patients who delivered spontaneously and those who required an OVD during delivery n°2. There were 7/51 (13.7%) patients who underwent an OVD during delivery n°2 with a newborn in cephalic posterior presentation compared to 20/469(4.3%) in cases of spontaneous vaginal delivery n°2 (p < 0.01). A posterior cephalic presentation increased the risk of subsequent OVD by 3.7 [Confidence Interval 95% (1.4-9.6), p < 0.01] CONCLUSION: In the case of a history of OVD, a low proportion of women required a repeated OVD (9.8%). The only factor associated with the need for repeated OVD was a persistent fetal cephalic posterior presentation at the time of delivery.

Ex utero intrapartum technique (EXIT): Indications, procedure methods and materno-fetal complications - A literature review.

A congenital malformation of the head, neck or thorax can lead to upper airway compression with a risk of asphyxia or neonatal death. To secure and protect the upper airway, the Ex Utero Intrapartum Therapy (EXIT) procedure has been developed. The procedure allows delivery of the fetus via a hysterotomy while relying on the placenta as the organ of respiration for the fetus prior to clamping of the umbilical cord. A high level of expertise is necessary for successful completion of the EXIT procedure, which is not void of maternal and fetal risks. In this literature review, we present the indications, procedure methods and materno-fetal complications associated with the EXIT procedure.

Inter-twin differences in fetal echocardiographic findings are associated with decreased dual twin survival in twin-twin transfusion syndrome.

OBJECTIVE: To determine if inter-twin differences in fetal echocardiographic findings are associated with fetal survival in monochorionic pregnancies complicated by twin-to-twin transfusion syndrome (TTTS). METHODS: This study included women who underwent laser surgery for TTTS between 2012 and 2018 at a single institution. Echocardiographic cardiac parameters in the donor and recipient twins were compared using Z-scores and regression analyses (adjusted for confounding variables) to determine whether any measurable inter-twin differences were associated with neonatal survival at birth. Results are expressed as (Odds ratio [95% confidence interval], p-value). RESULTS: Fetal echocardiography and delivery information was available in 124 TTTS cases. Dual live-birth occurred in 72% and at least one live-birth was seen in 89% of cases.Sixty-four percent (51/79) of recipient twins had evidence of cardiac dysfunction compared to 10% (8/79) of the donor twins (p < .01). In the logistic regression, inter-twin differences in left ventricle short axis dimension (0.62[0.44-0.87], p < .01), aortic valve diameter (0.67[0.45-0.99], p = .047), peak systolic velocity across the pulmonary artery (PA-PSV) (0.09[0.01-0.53], p < .01) and mitral valve diameter (0.56[0.38-0.84], p < .01) were associated with lower dual twin survival at birth. CONCLUSION: Inter-twin differences in left cardiac geometry and function are associated with decreased survival at delivery in TTTS.

Use of artificial intelligence to predict mean time to delivery following cervical ripening with dinoprostone vaginal insert.

OBJECTIVE: To validate a mathematical model to predict the mean time to delivery (TTD) following cervical ripening with dinoprostone vaginal insert (DVI), and assess its impact on the risk of nocturnal deliveries. METHODS: We performed a case-control retro-prospective study at Angers University Hospital. In the control group, we retrospectively included 405 patients who underwent cervical ripening with DVI between 01/2015 and 09/2016. Based on the delivery outcomes, we developed a mathematical model that integrates all the factors influencing TTD following cervical ripening with DVI. In the study group, we prospectively included 223 patients who underwent cervical ripening with DVI between 11/2017 and 11/2018. The timing of insertion was calculated using the mathematical model developed in the control group, in order to prevent the occurrence of nocturnal deliveries. RESULTS: The calculated mean TTD was significantly shorter than the real mean TTD (21h46 min ± 3h28 min versus 25h38 min ± 12h10 min, p < 0.001), and for 44% of patients, there was at least 10 h difference between the two. The real TTD (25h38 min ± 12H10 min versus 20h39 min ± 10h49, p < 0.001), and the rate of nocturnal deliveries (30.5% versus 21.2%, p = 0.01) were significantly higher in the study group compared to the control group. CONCLUSION: The mathematical model did not help predicting TTD following cervical ripening with DVI, and or reducing the number of nocturnal deliveries.

Impact of the type of endometrial oestrogen preparation for frozen-thawed embryo (vaginal or transdermal) on perinatal outcomes in an artificial cycle.

INTRODUCTION: Serum oestradiol concentration at the time of frozen embryo transfer (FET) in artificial cycle are lower when using transdermal administration of oestrogen for endometrial preparation compared to the vaginal route. This difference could have consequences for placentation and establishment of maternal-foetal circulation. The aim of our study was to compare the birth weight of newborns and the perinatal issues after FET in an artificial cycle with regard to the route of administration of oestrogens. METHODS: Retrospective monocentric cohort study in the medically assisted reproduction department of the University Hospital of Angers, France, between January 2017 and October 2020. Inclusion criteria were age >18 years old and one live birth after FET in an artificial cycle. The main outcome was the birth weight of the newborns. The choice of oestrogens administration (transdermal or vaginal) was left to the patient. RESULTS: 804 FET in artificial cycle were included in our study. Oestrogens were administrated in 356/804(36.6%) patients using transdermal route and in 448/804(45.9%) patients using vaginal route. There were 68/345 (19.1%) live births in the transdermal group and 85/448 (19%) in the vaginal group. There was no difference in the birth weight of the newborns (3320[2100-4165] grams in the transdermal group vs 3327.5[915-4650] grams in the vaginal group, p=0.72). All the other perinatal issues were comparable between the two groups. CONCLUSION: Birth weights and perinatal issues were comparable with regard to the route of administration of oestrogens (vaginal or transdermal) in the context of endometrial preparation before FET in an artificial cycle.

Impact of the volume of the myelomeningocele sac on imaging, prenatal neurosurgery and motor outcomes: a retrospective cohort study.

To investigate the association of the myelomeningocele (MMC) volume with prenatal and postnatal motor function (MF) in cases who underwent a prenatal repair. Retrospective cohort study (11/2011 to 03/2019) of 63 patients who underwent a prenatal MMC repair (37 fetoscopic, 26 open-hysterotomy). At referral, measurements of the volume of MMC was performed based on ultrasound scans. A large MMC was defined as greater than the optimal volume threshold (ROC analysis) for the prediction of intact MF at referral (2.7 cc). Prenatal or postnatal intact motor function (S1) was defined as the observation of plantar flexion of the ankle based on ultrasound scan or postnatal examination. 23/63 participants presented a large MMC. Large MMC lesions was associated with an increased risk of having clubfeet by 9.5 times (CI%95[2.1-41.8], p < 0.01), and reduces the chances of having an intact MF at referral by 0.19 times (CI%95[0.1-0.6], p < 0.01). At birth, a large MMC reduces the chance of having an intact MF by 0.09 times (CI%95[0.01-0.49], p < 0.01), and increases the risk of having clubfeet by 3.7 times (CI%95[0.8-18.3], p = 0.11). A lower proportion of intact MF and a higher proportion of clubfeet pre- or postnatally were observed in cases with a large MMC sac who underwent a prenatal repair.Trial registration: Clinicaltrials.gov NCT02230072 and NCT03794011 registered on September 3rd, 2014 and January 4th, 2019.

Is ventriculomegaly and hindbrain herniation seen before and after prenatal neural tube defect repair associated with a worse functional level than anatomical level at birth?

OBJECTIVE: To determine if the evaluation of the fetal ventricular system and hindbrain herniation (HBH) is associated with motor outcome at birth in prenatally repaired open neural tube defect (NTD). METHODS: Retrospective cohort study of 47 patients with NTD who underwent prenatal repair (17 fetoscopic; 30 open-hysterotomy). At referral and 6 weeks postoperatively, the degree of HBH, ventricular atrial widths and ventricular volume were evaluated by MRI. Head circumference and ventricular atrial widths were measured on ultrasound at referral and during the last ultrasound before delivery. Anatomic level of the lesion (LL) was determined based on the upper bony spinal defect detected by ultrasound. We considered the functional level as worse than anatomical level at birth when the motor level was equal or worse than the anatomical LL. RESULTS: 26% (12/47) of the cases showed worse functional level than anatomical level at birth. Having a HBH below C1 at the time of referral was associated with a worse functional level than anatomical level at birth (OR = 9.7, CI95 [2.2-42.8], p < 0.01). None of the other brain parameters showed a significant association with motor outcomes at birth. CONCLUSIONS: HBH below C1 before surgery was associated with a worse functional level than anatomical level at birth.

Impact of the cystic neural tube defects on fetal motor function in prenatal myelomeningocele repairs: A retrospective cohort study.

OBJECTIVE: To determine the impact of the lesion type (cystic [myelomeningocele] or flat [myeloschisis]) on the fetal motor function (MF) in cases candidates for prenatal open neural tube defect (ONTD) repair. METHODS: Retrospective cohort study of patients with ONTD who underwent prenatal repair at a single institution between 2011 and 2019. The lesion type and the measurements of the length and width of the lesions to calculate the surface of the ellipsoid lesion were performed using MR scans. Prenatal MF of the lower extremities was evaluated by ultrasound following a metameric distribution at the time of referral. Intact MF was defined as the observation of plantar flexion of the ankle. Logistic regression was performed to determine the predictive value of the type of lesion for having an intact MF at the time of referral. RESULTS: 103 patients were included at 22.9 (19-25.4) weeks; 65% had cystic and 35% had flat lesions. At the time of referral, there was a higher proportion of cases with an intact MF in the presence of flat lesions (34/36; 94.4%) as compared to cystic lesion (48/67; 71.6%, p < 0.01). When adjusting for gestational age and anatomical level of the lesion, flat ONTD were 3.1 times more likely to be associated by intact motor function (CI%95 [2.1-4.6], p < 0.01) at the time of referral. CONCLUSION: Cystic ONTD are more likely to be associated with impaired MF at mid-gestation in candidates for prenatal ONTD repair.

External cephalic version: Predictors for success.

OBJECTIVES: The objective of this study was to identify the factors predictive of the success of external cephalic version (ECV). METHODS: A single-centre retrospective observational study was performed in the maternity ward of the Angers University Hospital, France, between January 2010 and May 2020. The study included all patients (n = 613) for whom an ECV was performed for a breech or transverse foetus. The primary endpoint was measured by the success of the ECV, defined by the visualisation, using pelvic ultrasound, of the foetus in cephalic presentation immediately after the manoeuvre. Following to the ECV, the cohort was separated into two groups; ECV Success and ECV Failure. In order to determine the predictive factors of success, a logistic regression model was performed, including the parameters of: parity, foetal presentation during ECV, the side of the foetal back, placental location, type of operator and maternal age. The results are presented as (odds ratio [confidence intervals]; p-value). The significance threshold was defined by a p-value < 0.05. RESULTS: The ECV success rate was 21.4% (131/613). The factors predictive of the success of ECV were: transverse foetal presentation (2.7 [1.3-5.6]; p<0.01); a senior physician operator (1.6 [1.2-2]; p<0.01); multiparity (1.6 [1.2-2]; p<0.01); non anterior placental localization (1.4 [1.1-2]; p<0.01). A number of attempts greater than 3 were significantly associated with reduced chances of success (0.3 [0.2-0.4]; p<0.01). CONCLUSION: The study shows that transverse foetal presentation, a senior physician operator, multiparity, as well as a non-anterior placental location are factors predictive of the success of ECV. Knowledge of these factors can improve the information given to patients.

Two-port, exteriorized uterus, fetoscopic meningomyelocele closure has fewer adverse neonatal outcomes than open hysterotomy closure.

BACKGROUND: In utero closure of meningomyelocele using an open hysterotomy approach is associated with preterm delivery and adverse neonatal outcomes. OBJECTIVE: This study compared the neonatal outcomes in in utero meningomyelocele closure using a 2-port, exteriorized uterus, fetoscopic approach vs the conventional open hysterotomy approach. STUDY DESIGN: This retrospective cohort study included all consecutive patients who underwent in utero meningomyelocele closure using open hysterotomy (n=44) or a 2-port, exteriorized uterus, fetoscopic approach (n=46) at a single institution between 2012 and 2020. The 2-port, exteriorized uterus, fetoscopic closure was composed of the following 3 layers: a bovine collagen patch, a myofascial layer, and a skin. The frequency of respiratory distress syndrome and a composite of other adverse neonatal outcomes, including retinopathy of prematurity, periventricular leukomalacia, and perinatal death, were compared between the study groups. Regression analyses were performed to determine any association between the fetoscopic closure and adverse neonatal outcomes, adjusted for several confounders, including gestational age of <37 weeks at delivery. RESULTS: The fetoscopic closure was associated with a lower rate of respiratory distress syndrome than the open hysterotomy closure (11.5% [5 of 45] vs 29.5% [13 of 44]; P=.037). The proportion of neonates with a composite of other adverse neonatal outcomes in the fetoscopic group was half of that observed patients in the open hysterotomy group; however, this difference did not reach statistical significance (4.3% [2 of 46] vs 9.1% [4 of 44]; P=.429). Here, regression analysis has demonstrated that fetoscopic meningomyelocele closure was associated with a lower risk of respiratory distress syndrome (adjusted odds ratio, 0.23; 95% confidence interval, 0.06-0.84; P=.026) than open hysterotomy closure. CONCLUSION: In utero meningomyelocele closure using a 2-port, exteriorized uterus, fetoscopic approach was associated with a lower risk of respiratory distress syndrome than the conventional open hysterotomy meningomyelocele closure.

Delivery Mode After Manual Rotation of Occiput Posterior Fetal Positions: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether manual rotation of fetuses in occiput posterior positions at full dilation increases the rate of spontaneous vaginal delivery. METHODS: In an open, single-center, randomized controlled trial, patients with a term, singleton gestation, epidural analgesia, and ultrasonogram-confirmed occiput posterior position at the start of the second stage of labor were randomized to either manual rotation or expectant management. Our primary endpoint was the rate of spontaneous vaginal delivery. Secondary endpoints were operative vaginal delivery, cesarean delivery, and maternal and neonatal morbidity. Analyses were based on an intention-to-treat method. A sample size of 107 patients per group (n=214) was planned to detect a 20% increase in the percent of patients with a spontaneous vaginal delivery (assuming 60% without manual rotation vs 80% with manual rotation) with 90% power and alpha of 0.05. RESULTS: Between February 2017 and January 2020, 236 patients were randomized to either manual rotation (n=117) or expectant management (n=119). The success rate of the manual rotation maneuver, defined by conversion to an anterior position as confirmed by ultrasonogram, was 68%. The rate of the primary endpoint did not differ between the groups (58.1% in manual rotation group vs 59.7% in expectant management group (risk difference -1.6; 95% CI -14.1 to 11.0). Manual rotation did not decrease the rate of operative vaginal delivery (29.9% in manual rotation group vs 33.6% in expectant management group (risk difference -3.7; 95% CI -16.6 to 8.2) nor the rate of cesarean delivery (12.0% in manual rotation group vs 6.7% in expectant management group (risk difference 5.3; 95% CI -2.2 to 12.6). Maternal and neonatal morbidity was also similar across the two groups. CONCLUSION: Manual rotation of occiput posterior positions at the start of second stage of labor does not increase the rate of vaginal delivery without instrumental assistance. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03009435.