Clinical trial NCT06887634: Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head
Official title: Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head: a Randomized Clinical Trial - the ReMaP-POPP RCT -
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Persistent Occiput Posterior Position During Labor
Keywords: Occiput posterior position
Persistent Occiput Posterior Position
Rebozo technic
Maternal postures
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS San Gerardo dei Tintori
First posted: 2025-03-20
Enrollment: 578
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pragmatic, open-label, single-center randomized controlled trial with two parallel groups
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Probability of occiput posterior position of the fetal head three hours and thirty minutes after randomization
timeFrame: 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
Secondary outcomes:
measure: Probability of occiput posterior position confirmed by ultrasound examination at full cervical dilation
timeFrame: 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".
measure: Probability of occiput posterior position at delivery
timeFrame: 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
Other outcomes:
measure: Speed of cervical dilation during the first stage of labor
timeFrame: From date of randomization until the time of birth
measure: Duration of the second stage of labor
timeFrame: From the diagnosis of second stage, at full cervical dilation, up birth.
measure: Probability of suspicion of chorioamnionitis during labor
timeFrame: From the diagnosis of active phase of first stage of labour to birth
measure: Probability of oxytocin augmentation
timeFrame: From the diagnosis of active phase of first stage of labour to birth.
measure: Mode of delivery
timeFrame: At birth
measure: Perineal lacerations
timeFrame: At birth
measure: Severe postpartum hemorrhage
timeFrame: At birth
measure: Woman's pain intensity and ability to cope with pain
timeFrame: Within 30 minutes after randomization and at 3 hours and thirty minutes after randomization
measure: Maternal birth satisfaction level
timeFrame: Assessed at least 24 hours after delivery up hospital discharge
measure: Type of infant feeding at hospital discharge
timeFrame: Before hospital discharge, up to 5 days postpartum
measure: Type of infant feeding at 6-8 weeks post partum
timeFrame: At 6-8 weeks post partum
measure: Type of infant feeding at 6-9 months postpartum
timeFrame: At 6-9 months postpartum
measure: Umbilical arterial pH at birth
timeFrame: At birth
measure: Umbilical arterial Base Excess extracellular fluid (BEecf) at birth
timeFrame: At birth
measure: 1- and 5-minute Apgar scores
timeFrame: At 1 and 5 minutes after birth
measure: Rate of newborn who requires respiratory support
timeFrame: Until the first 2 hours after birth
measure: Rate of neonatal jaundice requiring phototherapy
timeFrame: Before hospital discharge, up to 5 days postpartum
measure: Rate of newborn who requires neonatal resuscitation
timeFrame: Before hospital discharge, up to 5 days postpartum
measure: Rate of newborn admission to neonatal intensive care unit
timeFrame: Before hospital discharge, up to 5 days postpartum
measure: Rate of birth trauma
timeFrame: Before hospital discharge, up to 5 days postpartum
measure: Rate of pelvic floor dysfunction
timeFrame: At 6-9 months postpartum
measure: Rate of sexual dysfunction
timeFrame: At 6-9 months postpartum
measure: Rate of normal pelvic floor muscle contraction
timeFrame: At 6-9 months postpartum
measure: Rate of organ prolapse
timeFrame: At 6-9 months postpartum
Locations:
city: Monza
country: Italy
facility: IRCCS San Gerardo dei Tintori
Study officials:
affiliation: School of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy
name: Sara Ornaghi, PHD
role: PRINCIPAL_INVESTIGATOR
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