Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head

Официальное название

Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head: a Randomized Clinical Trial - the ReMaP-POPP RCT -

Обзор

The goal of this clinical trial is to assess whether a combination of forward-leaning inversion and side-lying release procedures and Rebozo technique in a pre-specified sequence during the first stage of labor among women with a posterior fetus would favor anterior rotation. The main questions it aims to answer is: • What is the probability of persistent occiput posterior position of the fetal head three hours and thirty minutes after randomization, diagnosed by sonography? Researchers will compare the intervention group, which received a sequence of forward-leaning inversion (FLI), side-lying release procedures (SLR), and the Rebozo technique (lasting 90-105 minutes), to the control group, which received standard care (free maternal postures), to assess whether the specific combination of interventions in the experimental group reduces the probability of the fetal head remaining in the occiput posterior position. Participants in the intervention group will undergo a combination of forward-leaning inversion, side-lying release procedures, and the Rebozo technique, administered in a pre-determined sequence. In contrast, participants in the control group will receive standard care (free maternal postures).

Вмешательства

• Другое Rebozo and Maternal Procedures
  Combination of FLI and side-lying release SLR and Rebozo technique in a pre-specified order: 1\) FLI for 30 seconds repeated for 3 subconsequent contractions; 2) SLR for 30 seconds repeated for 3 consequent contractions; 3) Rest with free maternal postures for 15 minutes; 4) 15 minutes of Rebozo on maternal pelvis (women on hands and knees); 5) Rest with free maternal postures for 15 minutes; 6) 15 minutes of Rebozo on the side of the fetal spine (supine women). Duration of the intervention ra
• Другое Control
  Standard of care, including upright, semi-recumbent, lateral recumbent, and hands-and-knees position. They will not receive forward-leaning inversion (FLI) and side-lying release (SLR) and Rebozo technique. the control group will continue to adopt maternal postures with no possibility of performing the FLI or SLR procedures or the Rebozo technique until sonographic assessment of fetal head position is completed at 3 hours and thirty after randomization.

Первичные конечные точки

• Probability of occiput posterior position of the fetal head three hours and thirty minutes after randomization [Срок оценки: Three hours and thirty minutes after randomization. For women who will give birth before the end of the three hours and a half after randomization, fetal head position at birth will be considered as the fetal head position for this outcome]

Вторичные конечные точки (12)

• Probability of occiput posterior position confirmed by ultrasound examination at full cervical dilation [Срок оценки: full cervical dilation (before the beginning of active maternal pushing efforts); for women who will give birth before sonography at full dilation can be performed, information regarding fetal head position at this timing will be considered as "missing".]
• Probability of occiput posterior position at delivery [Срок оценки: At birth. In women undergoing operative delivery, the fetal head position diagnosed by sonography right before delivery will be considered as the position at birth]
• Duration of labor [Срок оценки: From the diagnosis of active first stage of labor up birth.]
• Mode of delivery [Срок оценки: At birth]
• Perineal lacerations [Срок оценки: At birth]
• Primary postpartum hemorrhage [Срок оценки: At birth]
• Woman's pain intensity and ability to cope with pain [Срок оценки: Within 30 minutes after randomization and at 3 hours and thirty minutes after randomization]
• Maternal birth satisfaction level [Срок оценки: Assessed at least 24 hours after delivery up hospital discharge]
• Rate of newborn admission to neonatal intensive care unit [Срок оценки: Before hospital discharge, up to 5 days postpartum]
• Rate of pelvic floor and sexual dysfunction [Срок оценки: At 6-9 months postpartum]
• Rate of pelvic floor and sexual dysfunction [Срок оценки: At 6-9 months postpartum]
• Rate of pelvic floor and sexual dysfunction [Срок оценки: At 6-9 months postpartum]

Критерии участия

Критерии включения

• woman in labor between 3 and 8 cm of cervical dilation
• woman with a singleton term fetus (≥37 0/7 weeks of gestation) in an Occiput Posterior Persistent Position clinically diagnosed and confirmed by transabdominal sonography

Критерии исключения

• Women with growth restricted fetuses according to the Delphi's consensus
• Fetuses with congenital anomalies or infections or with chromosomal abnormalities
• Intrauterine fetal demise
• Fetal and/or maternal conditions requiring urgent or emergent delivery or impeding the use of FLI and SLR and/or the Rebozo technique (non-reassuring fetal heart rate, abnormal vaginal bleeding, immobilizing epidural analgesia, polyhydramnios, extrapelvic fetal head, body mass index ≥35 Kg/m2, hypertensive disorders of pregnancy with inadequate control of blood pressure, maternal heart disease in class III to V according to the modified World Health Organization, glaucoma or ocular surgery, esophageal reflux disease, hypermobile sacro-ileac joint, and severe symphysis dysfunction)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• IRCCS San Gerardo dei Tintori — Monza

Публикации

• World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available. PMID 24141714
• Butcher NJ, Monsour A, Mew EJ, Chan AW, Moher D, Mayo-Wilson E, Terwee CB, Chee-A-Tow A, Baba A, Gavin F, Grimshaw JM, Kelly LE, Saeed L, Thabane L, Askie L, Smith M, Farid-Kapadia M, Williamson PR, Szatmari P, Tugwell P, Golub RM, Monga S, Vohra S, Marlin S, Ungar WJ, Offringa M. Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension. JAMA. 2022 Dec 13;328(22):225 PMID 36511921
• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available. PMID 20410783
• Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351. PMID 28937571
• Menard MK, Main EK, Currigan SM. Executive summary of the reVITALize initiative: standardizing obstetric data definitions. Obstet Gynecol. 2014 Jul;124(1):150-153. doi: 10.1097/AOG.0000000000000322. PMID 24901267
• Higgins RD, Saade G, Polin RA, Grobman WA, Buhimschi IA, Watterberg K, Silver RM, Raju TNK; Chorioamnionitis Workshop Participants. Evaluation and Management of Women and Newborns With a Maternal Diagnosis of Chorioamnionitis: Summary of a Workshop. Obstet Gynecol. 2016 Mar;127(3):426-436. doi: 10.1097/AOG.0000000000001246. PMID 26855098
• Frawley H, Shelly B, Morin M, Bernard S, Bo K, Digesu GA, Dickinson T, Goonewardene S, McClurg D, Rahnama'i MS, Schizas A, Slieker-Ten Hove M, Takahashi S, Voelkl Guevara J. An International Continence Society (ICS) report on the terminology for pelvic floor muscle assessment. Neurourol Urodyn. 2021 Jun;40(5):1217-1260. doi: 10.1002/nau.24658. Epub 2021 Apr 12. PMID 33844342
• Santoro GA, Wieczorek AP, Dietz HP, Mellgren A, Sultan AH, Shobeiri SA, Stankiewicz A, Bartram C. State of the art: an integrated approach to pelvic floor ultrasonography. Ultrasound Obstet Gynecol. 2011 Apr;37(4):381-96. doi: 10.1002/uog.8816. PMID 20814874

Идентификаторы

NCT: NCT06887634 · ID 5499_18.12.2024_M bis

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗