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

NCT06887634 | Not Yet Recruiting DMC

• 1 other identifier: ID 5499_18.12.2024_M bis
• Study Type: interventional
• Target: 578
• Locations: 1 country
• Sites: 1

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).

Conditions

Persistent Occiput Posterior Position During Labor

Keywords

Occiput posterior position; Persistent Occiput Posterior Position; Rebozo technic; Maternal postures

Outcome Measures

Primary Outcomes (1)

• Probability of occiput posterior position of the fetal head three hours and thirty minutes after randomization

  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.

  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 (13)

• 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

• Perineal lacerations

  At birth

Study Arms (2)

Rebozo and Maternal Procedures

ACTIVE COMPARATOR

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

Other: Rebozo and Maternal Procedures

Control group

ACTIVE COMPARATOR

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

Other: Control

Interventions

Rebozo and Maternal Procedures OTHER

Combination of FLI and side-lying release SLR and Rebozo technique in a pre-specified order: 1\) FLI for 30 seconds repeated for 3 subconsequent contractions; 2) SLR for 30 seconds repeated for 3 consequent contractions; 3) Rest with free maternal postures for 15 minutes; 4) 15 minutes of Rebozo on maternal pelvis (women on hands and knees); 5) Rest with free maternal postures for 15 minutes; 6) 15 minutes of Rebozo on the side of the fetal spine (supine women). Duration of the intervention ranges between 90 and 105 minutes. The intervention will start within thirty minutes after randomization; it can be interrupted at any time if needed. It will be considered performed when the proposed sequence is completed. After completion of the sequence, women will be allowed to move freely and adopt different postures. No FLI or SLR procedures or the Rebozo technique will be further allowed until sonographic assessment of the fetal head is performed at 3 hour and thirty after randomization

Rebozo and Maternal Procedures

Control OTHER

Standard of care, including upright, semi-recumbent, lateral recumbent, and hands-and-knees position. They will not receive forward-leaning inversion (FLI) and side-lying release (SLR) and Rebozo technique. the control group will continue to adopt maternal postures with no possibility of performing the FLI or SLR procedures or the Rebozo technique until sonographic assessment of fetal head position is completed at 3 hours and thirty after randomization.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Fondazione IRCCS San Gerardo dei Tintori: collaborator

Study Sites (1)

IRCCS San Gerardo dei Tintori

Monza, 20900, Italy

Location

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  PMID: 41067764 DERIVED

Related Links

• National Institute of Health. Racial and Ethnic Categories and Definitions for NIH Diversity Programs and for Other Reporting Purposes 2015
• ClinicalTrials.gov

Study Officials

• Sara Ornaghi, PHD

  School of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Panzeri, PHD student

CONTACT

00393337422526; maria.panzeri@unimib.it

Simona Fumagalli, PHD

CONTACT

00393935554696; simona.fumagalli@unimib.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pragmatic, open-label, single-center randomized controlled trial with two parallel groups

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: After the first publication of the primary results up to 5 years
• Access Criteria: Data access will be permitted upon submission of a brief proposal outlining the intended use, which will be reviewed by the study team.

Locations

IT (1)