Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head (ReMaP-POPP)

University of Milano Bicocca

Status: Begins enrollment this month

Conditions: Persistent Occiput Posterior Position During Labor

Treatments: Other: Control; Other: Rebozo and Maternal Procedures

Study type: Interventional

Funder types: Other

Identifiers

NCT06887634

ID 5499_18.12.2024_M bis

Details and patient eligibility

About

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).

Enrollment: 578 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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578 participants in 2 patient groups

Rebozo and Maternal Procedures

Active Comparator group

Description:

Combination of forward-leaning inversion (FLI) and side-lying release (SLR) and Rebozo technique in a pre-specified order (see Assigned Interventions).

Treatment:

Other: Rebozo and Maternal Procedures

Control group

Active Comparator group

Description:

Standard of care, including upright, semi-recumbent, lateral recumbent, and hands-and-knees position.

Treatment:

Other: Control