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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Persistent Occiput Posterior Position During Labor
• Intervention / Treatment: Other: Rebozo and Maternal Procedures; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 578
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Panzeri, PHD student; Phone Number: 00393337422526; Email: maria.panzeri@unimib.it
• Study Contact Backup: Name: Simona Fumagalli, PHD; Phone Number: 00393935554696; Email: simona.fumagalli@unimib.it

Study Locations

• Italy
  • Monza, Italy, 20900
    • IRCCS San Gerardo Dei Tintori
    • Principal Investigator: Sara Ornaghi
    • Contact: Sara Ornaghi; Phone Number: 00393381693586; Email: sara.ornaghi@unimib.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Other: 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
Active Comparator: Control group; Standard of care, including upright, semi-recumbent, lateral recumbent, and hands-and-knees position.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probability of occiput posterior position confirmed by ultrasound examination at full cervical dilation	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".	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	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	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
Mode of delivery	This outcome could be measured calculating the probability of experiencing a spontaneous vaginal birth, a vacuum assisted vaginal birth or a caesarean section	At birth
Perineal lacerations	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.	At birth
Woman's pain intensity and ability to cope with pain	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').	Within 30 minutes after randomization and at 3 hours and thirty minutes after randomization
Maternal birth satisfaction level	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).	Assessed at least 24 hours after delivery up hospital discharge
Rate of newborn admission to neonatal intensive care unit	This outcome will be measured calculating the probability of neonatal intensive care unit admission until hospital discharge	Before hospital discharge, up to 5 days postpartum
Duration of labor	This outcome will be measured calculating the time (minutes) between the diagnosis of active first stage of labor and birth.	From the diagnosis of active first stage of labor up birth.
Primary postpartum hemorrhage	This outcome will be measured by calculating the probability of blood loss ≥1000 mL	At birth
Rate of pelvic floor and sexual dysfunction	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.	At 6-9 months postpartum
Rate of pelvic floor and sexual dysfunction	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.	At 6-9 months postpartum
Rate of pelvic floor and sexual dysfunction	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.	At 6-9 months postpartum
Rate of pelvic floor and sexual dysfunction	This outcome will be measured through: - Modified Oxford Grading System. It ranges from 0 to 5 and higher scores indicate better muscle strength.	At 6-9 months postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speed of cervical dilation during the first stage of labor	This outcome will be calculated by dividing the total change in cervical dilation (cm) by the duration of first stage of labor (hours).	From date of randomization until the time of birth
Duration of the second stage of labor	This outcome will be measured calculating the time (minutes) between the diagnosis of second stage, at full cervical dilation, and birth.	From the diagnosis of second stage, at full cervical dilation, up birth.
Probability of suspicion of chorioamnionitis during labor	This outcome will be measured by calculating the probability of having chorioamnionitis during any of the labour stages. Chorioamnionitis will be diagnosed when fever is present with one or more of the following: 1) Fetal tachycardia (greater than 160 beats per minute for 10 minutes or longer); 2) Maternal White Blood Cells count greater than 15,000 in the absence of corticosteroids; 3) Purulent fluid from the cervical os (cloudy or yellowish thick discharge confirmed visually on speculum examination to be coming from the cervical canal); 4) Biochemical or microbiologic amniotic fluid results consistent with microbial invasion of the amniotic cavity. The diagnosis of fever be standardized as follows: maternal temperature ≥39.0°C on one reading constitutes a fever. If the temperature is ≥38.0°C or greater but < 39.0°C, the temperature should be retaken in 30 minutes for confirmation. A repeat temperature ≥38.0°C constitutes a documented fever. Temperature should be measured orally	From the diagnosis of active phase of first stage of labour to birth
Probability of oxytocin augmentation	This outcome will be measured calculating the probability of receiving ocytocin From the diagnosis of active phase of first stage of labour to birth.	From the diagnosis of active phase of first stage of labour to birth.
Mode of delivery	This outcome could be measured calculating the probability of experiencing a spontaneous vaginal birth, a vacuum assisted vaginal birth or a caesarean section	At birth
Perineal lacerations	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.	At birth
Severe postpartum hemorrhage	This outcome will be measured by calculating the probability of blood loss ≥1500 mL or needing additional interventions to control bleeding, including one ore more of the following: 1)dilation & curettage; 2) uterine balloon tamponade; 3) arterial embolization; 4)uterine artery ligation; 5) uterine compressive sutures; 6) hysterectomy	At birth
Woman's pain intensity and ability to cope with pain	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').	Within 30 minutes after randomization and at 3 hours and thirty minutes after randomization
Maternal birth satisfaction level	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).	Assessed at least 24 hours after delivery up hospital discharge
Type of infant feeding at hospital discharge	Type of infant feeding at hospital discharge will be measured calculating the probability of different type of infant feeding at hospital discharge. The infant feeding will be classified into one of four categories: 1)exclusive breastfeeding (infants have been fed only breastmilk, but the definition allows for medicines, vitamins and oral re-hydration solution to have been given), 2)breastfeeding and non-milk liquids, 3) complementary breastfeeding (infants have been fed breastmilk, other milk or formula milk, complementary foods), 4) no breastfeeding.	Before hospital discharge, up to 5 days postpartum
Type of infant feeding at 6-8 weeks post partum	Type of infant feeding at 6-8 weeks post partum will be measured calculating the probability of different type of infant feeding. The infant feeding will be classified into one of four categories: 1) exclusive breastfeeding (infants have been fed only breastmilk, but the definition allows for medicines, vitamins and oral re-hydration solution to have been given), 2) breastfeeding and non-milk liquids, 3) complementary breastfeeding (infants have been fed breastmilk, other milk or formula milk, complementary foods), 4) no breastfeeding.	At 6-8 weeks post partum
Type of infant feeding at 6-9 months postpartum	Type of infant feeding at 6-9 months post partum will be measured calculating the probability of different type of infant feeding. The infant feeding will be classified into one of four categories: 1) exclusive breastfeeding (infants have been fed only breastmilk, but the definition allows for medicines, vitamins and oral re-hydration solution to have been given), 2) breastfeeding and non-milk liquids, 3) complementary breastfeeding (infants have been fed breastmilk, other milk or formula milk, complementary foods), 4) no breastfeeding	At 6-9 months postpartum
Umbilical arterial pH at birth	This outcome will be measured through the umbilical cord blood emogasanalisis, specifically pH at birth	At birth
Umbilical arterial Base Excess extracellular fluid (BEecf) at birth	This outcome will be measured through the umbilical cord blood emogasanalisis, specifically BEecf at birth	At birth
1- and 5-minute Apgar scores	This outcome will be measured using the Apgar score given at 1 and 5 minutes after birth. Apgar score range from 0 to 10 with higher scores indicating a better clinical condition. The score is based on five criteria: heart rate, respiratory effort, muscle tone, reflex response, and skin color, each rated from 0 to 2	At 1 and 5 minutes after birth
Rate of newborn who requires respiratory support	This outcome will be measured by calculating the probability of requiring neonatal respiratory support.	Until the first 2 hours after birth
Rate of neonatal jaundice requiring phototherapy	This outcome will be measured calculating the probability of neonatal jaundice requiring phototherapy until the hospital discharge	Before hospital discharge, up to 5 days postpartum
Rate of newborn who requires neonatal resuscitation	This outcome will be measured calculating the probability of neonatal resuscitation until hospital discharge	Before hospital discharge, up to 5 days postpartum
Rate of newborn admission to neonatal intensive care unit	This outcome will be measured calculating the probability of neonatal intensive care unit admission until hospital discharge	Before hospital discharge, up to 5 days postpartum
Rate of birth trauma	This outcome will be measured calculating the probability of birth trauma until hospital discharge. Birth trauma is classified in clavicle fracture, brachial plexus injury, and subgaleal hematoma.	Before hospital discharge, up to 5 days postpartum
Rate of pelvic floor dysfunction	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	At 6-9 months postpartum
Rate of sexual dysfunction	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.	At 6-9 months postpartum
Rate of normal pelvic floor muscle contraction	This outcome will be measured through: - Modified Oxford Grading System. It ranges from 0 to 5 and higher scores indicate better muscle strength.	At 6-9 months postpartum
Rate of organ prolapse	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.	At 6-9 months postpartum

Collaborators and Investigators

• Sponsor: University of Milano Bicocca
• Collaborators: Fondazione IRCCS San Gerardo dei Tintori
• Investigators: Principal Investigator: Sara Ornaghi, PHD, School of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy

Publications and helpful links

General Publications

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Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Occiput posterior position; Persistent Occiput Posterior Position; Rebozo technic; Maternal postures
• Other Study ID Numbers: ID 5499_18.12.2024_M bis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data, the data dictionary, and statistical analysis code will be made available upon reasonable request after publication of the primary results. Materials related to the intervention (including any instructional tools used in the trial) will also be shared if applicable. Data access will require submission of a brief proposal outlining the intended use, which will be reviewed by the study team. Approved data will be shared via secure data transfer platforms. Consent for future data sharing will be obtained from all participants at the time of enrollment. No commercial use of the data will be permitted.
• IPD Sharing Time Frame: After the first publication of the primary results up to 5 years
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No