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NCT Number: NCT06887634

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

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).

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Key information

Conditions

Persistent Occiput Posterior Position During Labor

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rebozo and Maternal Procedures

Other

Combination of FLI and side-lying release SLR and Rebozo technique in a pre-specified order:

  • 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

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Probability of occiput posterior position confirmed by ultrasound examination at full cervical dilation

    Time frame: 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".

  2. Probability of occiput posterior position at delivery

    Time frame: 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

  3. Duration of labor

    Time frame: From the diagnosis of active first stage of labor up birth.

    This outcome will be measured calculating the time (minutes) between the diagnosis of active first stage of labor and birth.

  4. Mode of delivery

    Time frame: At birth

    This outcome could be measured calculating the probability of experiencing a spontaneous vaginal birth, a vacuum assisted vaginal birth or a caesarean section

  5. Perineal lacerations

    Time frame: At birth

    This outcome will be measured by calculating within women who had spontaneous vaginal birth or vacuum assisted vaginal birth, the probability of having third degree perineal tear, of having fourth degree of perineal tear, of having episiotomy.

  6. Primary postpartum hemorrhage

    Time frame: At birth

    This outcome will be measured by calculating the probability of blood loss ≥1000 mL

  7. Woman's pain intensity and ability to cope with pain

    Time frame: Within 30 minutes after randomization and at 3 hours and thirty minutes after randomization

    This outcome will be measured using the Pain Intensity Scale, ranging from 0 to 10 (0 equal to 'no pain' and 10 equal to 'worst pain imaginable), and the Pain Coping Scale, ranging from 10 to 0 (10 equal to 'no need to cope - very easy' and 0 'totally unable to cope').

  8. Maternal birth satisfaction level

    Time frame: Assessed at least 24 hours after delivery up hospital discharge

    This outcome will be measured using the italian version of "Birth Satisfaction Scale-Revised" (BSS-R), ranging from 0 to 40 (higher scores is associated to higher maternal satisfaction at birth).

  9. Rate of newborn admission to neonatal intensive care unit

    Time frame: Before hospital discharge, up to 5 days postpartum

    This outcome will be measured calculating the probability of neonatal intensive care unit admission until hospital discharge

  10. Rate of pelvic floor and sexual dysfunction

    Time frame: At 6-9 months postpartum

    This outcome will be measured through:

    Pelvic Floor Disability Index (PFDI-20) for pelvic floor dysfunction assessment. It ranges from 0 to 300 and higher scores indicate greater pelvic floor dysfunction and distress.

  11. Rate of pelvic floor and sexual dysfunction

    Time frame: At 6-9 months postpartum

    This outcome will be measured through:

    Validated Italian-language questionnaires: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12, short form) for sexual function assessment. It ranges from 0 to 48 and higher scores indicate better sexual function.

  12. Rate of pelvic floor and sexual dysfunction

    Time frame: At 6-9 months postpartum

    This outcome will be measured through:

    • Pelvic Organ Prolapse Quantification (POP-Q) score to evaluate prolapse severity. It ranges from 0 stage to IV stage and higher stages indicate more severe pelvic organ prolapse.

  13. Rate of pelvic floor and sexual dysfunction

    Time frame: At 6-9 months postpartum

    This outcome will be measured through:

    • Modified Oxford Grading System. It ranges from 0 to 5 and higher scores indicate better muscle strength.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Panzeri, PHD student

CONTACT

[email protected]

00393337422526

Simona Fumagalli, PHD

CONTACT

[email protected]

00393935554696

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Collaborators

  • Fondazione IRCCS San Gerardo dei Tintori

Registry information

Official study title

Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head: a Randomized Clinical Trial - the ReMaP-POPP RCT -

Acronym: ReMaP-POPP

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 20, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.