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

NCT ID: NCT06887634

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

578 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-07-31

Brief Summary

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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

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Conditions

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Persistent Occiput Posterior Position During Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

pragmatic, open-label, single-center randomized controlled trial with two parallel groups
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Rebozo and Maternal Procedures

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

Group Type ACTIVE_COMPARATOR

Rebozo and Maternal Procedures

Intervention Type 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

Control group

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type 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.

Interventions

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Rebozo and Maternal Procedures

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

Intervention Type OTHER

Control

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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS San Gerardo dei Tintori

OTHER

Sponsor Role collaborator

University of Milano Bicocca

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sara Ornaghi, PHD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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IRCCS San Gerardo dei Tintori

Monza, , Italy

Site Status

Countries

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Italy

Central Contacts

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Maria Panzeri, PHD student

Role: CONTACT

00393337422526

Simona Fumagalli, PHD

Role: CONTACT

00393935554696

Facility Contacts

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Sara Ornaghi

Role: primary

00393381693586

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Related Links

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https://grants-nih-gov.unimib.idm.oclc.org/grants/guide/notice-files/NOT-OD-15-089.html

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

Other Identifiers

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ID 5499_18.12.2024_M bis

Identifier Type: -

Identifier Source: org_study_id

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