Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06887634 | NOT YET RECRUITING | Persistent Occiput Posterior Position During Labor

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

University of Milan 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).

Condition or disease

Persistent Occiput Posterior Position During Labor

Intervention/treatment

Rebozo and Maternal Procedures

Control

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 578 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head: a Randomized Clinical Trial - the ReMaP-POPP RCT -
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2026-10
Estimated Study Completion Date : 2027-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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)
Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head

Location Details

NCT06887634

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Italy,

IRCCS San Gerardo dei Tintori

Monza, Italy, 20900