Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head: a Randomized Clinical Trial - the ReMaP-POPP RCT -
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 578
- 试验地点
- 2
- 主要终点
- Probability of occiput posterior position of the fetal head three hours and thirty minutes after randomization
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Probability of occiput posterior position of the fetal head three hours and thirty minutes after randomization
时间窗: 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
This outcome will be measured by suprapubic transabdominal sonography by a trained clinician blinded to the randomization group. The fetal head position will be classified into one of three categories: occiput anterior (right and left), occiput transverse (right and left), and occiput posterior (right and left). If fetal head position cannot be clearly defined, sonography will be repeated by another trained, senior clinician. 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.
次要结局
- Probability of occiput posterior position confirmed by ultrasound examination at full cervical dilation(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(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)
- Probability of occiput posterior position confirmed by ultrasound examination at full cervical dilation(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(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(From the diagnosis of active first stage of labor up birth.)
- Mode of delivery(At birth)
- Rate of pelvic floor and sexual dysfunction(At 6-9 months postpartum)
- Perineal lacerations(At birth)
- Woman's pain intensity and ability to cope with pain(Within 30 minutes after randomization and at 3 hours and thirty minutes after randomization)
- Primary postpartum hemorrhage(At birth)
- Maternal birth satisfaction level(Assessed at least 24 hours after delivery up hospital discharge)
- Rate of newborn admission to neonatal intensive care unit(Before hospital discharge, up to 5 days postpartum)