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

Not Applicable

Not yet recruiting

• Conditions: Persistent Occiput Posterior Position During Labor

• Registration Number: NCT06887634
• Lead Sponsor: University of Milano Bicocca

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Study Start: 2025-06
• Primary Completion: 2026-10
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 578

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Probability of occiput posterior position of the fetal head three hours and thirty minutes after randomization	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.

Secondary Outcome Measures

Name	Time	Method
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".	This outcome will be measured, before the beginning of active maternal pushing efforts, 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 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	This outcome will be measured by clinical diagnosis 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

Trial Locations

Locations (1)

IRCCS San Gerardo dei Tintori; 🇮🇹 Monza, Italy