The impact of manual rotation of the occiput posterior position on spontaneous vaginal delivery rate: study protocol for a randomized clinical trial (RMOS)
| العنوان: | The impact of manual rotation of the occiput posterior position on spontaneous vaginal delivery rate: study protocol for a randomized clinical trial (RMOS) |
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| المؤلفون: | Philippe Descamps, Guillaume Legendre, Philippe Gillard, Caroline Verhaeghe, F. Biquard, Elsa Parot-Schinkel, S. Madzou, Pierre-Emmanuel Bouet |
| المساهمون: | Laboratoire d'Ergonomie et d'Épidémiologie en Santé au Travail (LEEST), Université d'Angers (UA)-Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM)-Institut de Veille Sanitaire (INVS), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Laboratoire pluridisciplinaire de recherche en ingénierie des systèmes, mécanique et énergétique (PRISME), Université d'Orléans (UO)-Institut National des Sciences Appliquées - Centre Val de Loire (INSA CVL), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA), Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS) |
| المصدر: | Trials Trials, BioMed Central, 2018, 19, pp.109. ⟨10.1186/s13063-018-2497-7⟩ Trials, Vol 19, Iss 1, Pp 1-8 (2018) |
| بيانات النشر: | HAL CCSD, 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | Time Factors, [SDV]Life Sciences [q-bio], Cesarean, Medicine (miscellaneous), Extraction, law.invention, Labor Presentation, Study Protocol, 0302 clinical medicine, Posterior position, Randomized controlled trial, law, Pregnancy, Operative vaginal delivery, Prenatal, Pharmacology (medical), 030212 general & internal medicine, Prospective Studies, Version, Fetal, Prospective cohort study, Vaginal delivery, Randomized Controlled Trials as Topic, Ultrasonography, lcsh:R5-920, 030219 obstetrics & reproductive medicine, Transabdominal ultrasound, Obstetrics, Gestational age, Extraction, Obstetrical, 3. Good health, Obstetric labor complication, Version, Exact test, medicine.anatomical_structure, Treatment Outcome, Female, France, lcsh:Medicine (General), Live Birth, medicine.medical_specialty, Rotation, Term Birth, Obstetrical, Fetal position, Gestational Age, Ultrasonography, Prenatal, Manual rotation, Fetal, 03 medical and health sciences, Anterior position, medicine, Humans, business.industry, Cesarean Section, Occiput, medicine.disease, Obstetric Labor Complications, business, Occiput posterior position |
| الوصف: | 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 Electronic supplementary material The online version of this article (10.1186/s13063-018-2497-7) contains supplementary material, which is available to authorized users. |
| اللغة: | English |
| تدمد: | 1745-6215 |
| DOI: | 10.1186/s13063-018-2497-7⟩ |
| DOI: | 10.1186/s13063-018-2497-7 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2c73709c390a8de5d2019ad58b821d8b https://hal.univ-angers.fr/hal-02616905 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....2c73709c390a8de5d2019ad58b821d8b |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 17456215 |
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| DOI: | 10.1186/s13063-018-2497-7⟩ |