Persistent Occiput Posterior Position During LaborReMaP-POPPNCT06887634

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

A study testing Rebozo and Maternal Procedures in people with Persistent Occiput Posterior Position During Labor, run by University of Milano Bicocca at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Persistent Occiput Posterior Position During Labor
What is being tested?: Rebozo and Maternal Procedures
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 578 participants
Where: 1 siteItaly
Study dates: Sep 2025to Jul 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maria Panzeri, PHD student contact

00393337422526

maria.panzeri@unimib.it

Simona Fumagalli, PHD contact

00393935554696

simona.fumagalli@unimib.it

Italy1 site

IRCCS San Gerardo dei Tintori
Monza, 20900
Sara Ornaghi, 00393381693586, sara.ornaghi@unimib.it
Sara Ornaghi

Other trials in Italy

About this study

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

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
Being tested: Rebozo and Maternal Procedures, Control
Keywords: Occiput posterior position, Persistent Occiput Posterior Position, Rebozo technic, Maternal postures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rebozo and Maternal ProceduresOther
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
ControlOther
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.

Study groups in NCT06887634
Study group	Role	What they receive
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). Receives: Other: Rebozo and Maternal Procedures
Control group	Active comparator	Standard of care, including upright, semi-recumbent, lateral recumbent, and hands-and-knees position. Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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".
Measured: 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
Measured: 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
This outcome will be measured calculating the time (minutes) between the diagnosis of active first stage of labor and birth.
Measured: From the diagnosis of active first stage of labor up 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
Measured: 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.
Measured: At birth
Primary postpartum hemorrhage
This outcome will be measured by calculating the probability of blood loss ≥1000 mL
Measured: 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').
Measured: 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).
Measured: 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
Measured: Before hospital discharge, up to 5 days postpartum
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6-9 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2025Jul 2027

First posted20 Mar 2025
Study startSep 2025 (estimated)
Primary completionOct 2026 (estimated)
Study completionJul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (81)Papers the sponsor has linked to this study.
Other trials for Persistent Occiput Posterior Position During LaborStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: pragmatic, open-label, single-center randomized controlled trial with two parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 578 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06887634
Sponsor's protocol ID: ID 5499_18.12.2024_M bis
Acronym: ReMaP-POPP
Status last verified: Mar 2025
First submitted: 6 Mar 2025
Last updated: 5 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
PubMed 24141714
Butcher NJ, Monsour A, Mew EJ, Chan AW, Moher D, Mayo-Wilson E, Terwee CB, Chee-A-Tow A, Baba A, Gavin F, Grimshaw JM, Kelly LE, Saeed L, Thabane L, Askie L, Smith M, Farid-Kapadia M, Williamson PR, Szatmari P, Tugwell P, Golub RM, Monga S, Vohra S, Marlin S, Ungar WJ, Offringa M. Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension. JAMA. 2022 Dec 13;328(22):2252-2264. doi: 10.1001/jama.2022.21022.
PubMed 36511921
Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available.
PubMed 20410783
Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
PubMed 28937571
Menard MK, Main EK, Currigan SM. Executive summary of the reVITALize initiative: standardizing obstetric data definitions. Obstet Gynecol. 2014 Jul;124(1):150-153. doi: 10.1097/AOG.0000000000000322.
PubMed 24901267
Higgins RD, Saade G, Polin RA, Grobman WA, Buhimschi IA, Watterberg K, Silver RM, Raju TNK; Chorioamnionitis Workshop Participants. Evaluation and Management of Women and Newborns With a Maternal Diagnosis of Chorioamnionitis: Summary of a Workshop. Obstet Gynecol. 2016 Mar;127(3):426-436. doi: 10.1097/AOG.0000000000001246.
PubMed 26855098
Frawley H, Shelly B, Morin M, Bernard S, Bo K, Digesu GA, Dickinson T, Goonewardene S, McClurg D, Rahnama'i MS, Schizas A, Slieker-Ten Hove M, Takahashi S, Voelkl Guevara J. An International Continence Society (ICS) report on the terminology for pelvic floor muscle assessment. Neurourol Urodyn. 2021 Jun;40(5):1217-1260. doi: 10.1002/nau.24658. Epub 2021 Apr 12.
PubMed 33844342
Santoro GA, Wieczorek AP, Dietz HP, Mellgren A, Sultan AH, Shobeiri SA, Stankiewicz A, Bartram C. State of the art: an integrated approach to pelvic floor ultrasonography. Ultrasound Obstet Gynecol. 2011 Apr;37(4):381-96. doi: 10.1002/uog.8816.
PubMed 20814874
Dietz HP. Pelvic floor ultrasound: a review. Am J Obstet Gynecol. 2010 Apr;202(4):321-34. doi: 10.1016/j.ajog.2009.08.018.
PubMed 20350640
Dietz HP. Ultrasound imaging of the pelvic floor. Part I: two-dimensional aspects. Ultrasound Obstet Gynecol. 2004 Jan;23(1):80-92. doi: 10.1002/uog.939.
PubMed 14971006
Dietz HP. Pelvic Floor Ultrasound: A Review. Clin Obstet Gynecol. 2017 Mar;60(1):58-81. doi: 10.1097/GRF.0000000000000264.
PubMed 28005595
Volonte' S, Barba M, Cola A, Marino G, Frigerio M. Italian validation of the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J. 2022 Nov;33(11):3171-3175. doi: 10.1007/s00192-022-05235-0. Epub 2022 Jun 1.
PubMed 35648181
Ferreira CH, Barbosa PB, de Oliveira Souza F, Antonio FI, Franco MM, Bo K. Inter-rater reliability study of the modified Oxford Grading Scale and the Peritron manometer. Physiotherapy. 2011 Jun;97(2):132-8. doi: 10.1016/j.physio.2010.06.007. Epub 2010 Oct 22.
PubMed 21497247
Barba M, Cola A, Melocchi T, Braga A, Castronovo F, Manodoro S, Pennacchio M, Munno GM, Ruffolo AF, Degliuomini RS, Salvatore S, Torella M, Frigerio M. Italian validation of the Pelvic Floor Distress Inventory (PFDI-20) questionnaire. Int Urogynecol J. 2023 Oct;34(10):2459-2465. doi: 10.1007/s00192-023-05572-8. Epub 2023 May 17.
PubMed 37195425
Nespoli A, Colciago E, Fumagalli S, Locatelli A, Hollins Martin CJ, Martin CR. Validation and factor structure of the Italian version of the Birth Satisfaction Scale-Revised (BSS-R). J Reprod Infant Psychol. 2021 Nov;39(5):516-531. doi: 10.1080/02646838.2020.1836333. Epub 2020 Oct 21.
PubMed 33084372

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rebozo and Maternal Procedures to Reduce Persistent Occiput Posterior Position of the Fetal Head: a Randomized Clinical Trial - the ReMaP-POPP RCT -
ClinicalTrials.gov ID: NCT06887634
Acronym / sponsor ID: ReMaP-POPP / ID 5499_18.12.2024_M bis
Conditions: Persistent Occiput Posterior Position During Labor
Keywords: Occiput posterior position, Persistent Occiput Posterior Position, Rebozo technic, Maternal postures
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 578 participants (estimated)
Lead sponsor: University of Milano BicoccaUniversity, hospital or other
Collaborators: Fondazione IRCCS San Gerardo dei Tintori
Study start: Sep 2025 (estimated)
Primary completion: Oct 2026 (estimated)
Study completion: Jul 2027 (estimated)
First posted: 20 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: pragmatic, open-label, single-center randomized controlled trial with two parallel groups

Arm	Type	Receives
Rebozo and Maternal Procedures	Active comparator	Other: Rebozo and Maternal ProceduresCombination of forward-leaning inversion (FLI) and side-lying release (SLR) and Rebozo technique in a pre-specified order (see Assigned Interventions).
Control group	Active comparator	Other: ControlStandard of care, including upright, semi-recumbent, lateral recumbent, and hands-and-knees position.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rebozo and Maternal ProceduresCombination 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	Other	Rebozo and Maternal Procedures
ControlStandard 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.	Other	Control group

Primary outcome

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.

13 secondary outcomes

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".
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
Duration of labor
Time frame: From the diagnosis of active first stage of labor up birth.
Mode of delivery
Time frame: At birth
Perineal lacerations
Time frame: At birth
Primary postpartum hemorrhage
Time frame: At birth
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
Maternal birth satisfaction level
Time frame: Assessed at least 24 hours after delivery up hospital discharge
Rate of newborn admission to neonatal intensive care unit
Time frame: Before hospital discharge, up to 5 days postpartum
Rate of pelvic floor and sexual dysfunction
Time frame: At 6-9 months postpartum
Rate of pelvic floor and sexual dysfunction
Time frame: At 6-9 months postpartum
Rate of pelvic floor and sexual dysfunction
Time frame: At 6-9 months postpartum
Rate of pelvic floor and sexual dysfunction
Time frame: At 6-9 months postpartum

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
Background: PubMed 24141714World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
Background: PubMed 36511921Butcher NJ, Monsour A, Mew EJ, Chan AW, Moher D, Mayo-Wilson E, Terwee CB, Chee-A-Tow A, Baba A, Gavin F, Grimshaw JM, Kelly LE, Saeed L, Thabane L, Askie L, Smith M, Farid-Kapadia M, Williamson PR, Szatmari P, Tugwell P, Golub RM, Monga S, Vohra S, Marlin S, Ungar WJ, Offringa M. Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension. JAMA. 2022 Dec 13;328(22):2252-2264. doi: 10.1001/jama.2022.21022.
Background: PubMed 20410783Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available.
Background: PubMed 28937571Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
Background: PubMed 24901267Menard MK, Main EK, Currigan SM. Executive summary of the reVITALize initiative: standardizing obstetric data definitions. Obstet Gynecol. 2014 Jul;124(1):150-153. doi: 10.1097/AOG.0000000000000322.
Background: PubMed 26855098Higgins RD, Saade G, Polin RA, Grobman WA, Buhimschi IA, Watterberg K, Silver RM, Raju TNK; Chorioamnionitis Workshop Participants. Evaluation and Management of Women and Newborns With a Maternal Diagnosis of Chorioamnionitis: Summary of a Workshop. Obstet Gynecol. 2016 Mar;127(3):426-436. doi: 10.1097/AOG.0000000000001246.
Background: PubMed 33844342Frawley H, Shelly B, Morin M, Bernard S, Bo K, Digesu GA, Dickinson T, Goonewardene S, McClurg D, Rahnama'i MS, Schizas A, Slieker-Ten Hove M, Takahashi S, Voelkl Guevara J. An International Continence Society (ICS) report on the terminology for pelvic floor muscle assessment. Neurourol Urodyn. 2021 Jun;40(5):1217-1260. doi: 10.1002/nau.24658. Epub 2021 Apr 12.
Background: PubMed 20814874Santoro GA, Wieczorek AP, Dietz HP, Mellgren A, Sultan AH, Shobeiri SA, Stankiewicz A, Bartram C. State of the art: an integrated approach to pelvic floor ultrasonography. Ultrasound Obstet Gynecol. 2011 Apr;37(4):381-96. doi: 10.1002/uog.8816.
Background: PubMed 20350640Dietz HP. Pelvic floor ultrasound: a review. Am J Obstet Gynecol. 2010 Apr;202(4):321-34. doi: 10.1016/j.ajog.2009.08.018.
Background: PubMed 14971006Dietz HP. Ultrasound imaging of the pelvic floor. Part I: two-dimensional aspects. Ultrasound Obstet Gynecol. 2004 Jan;23(1):80-92. doi: 10.1002/uog.939.
Background: PubMed 28005595Dietz HP. Pelvic Floor Ultrasound: A Review. Clin Obstet Gynecol. 2017 Mar;60(1):58-81. doi: 10.1097/GRF.0000000000000264.
Background: PubMed 35648181Volonte' S, Barba M, Cola A, Marino G, Frigerio M. Italian validation of the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J. 2022 Nov;33(11):3171-3175. doi: 10.1007/s00192-022-05235-0. Epub 2022 Jun 1.
National Institute of Health. Racial and Ethnic Categories and Definitions for NIH Diversity Programs and for Other Reporting Purposes 2015Link provided by the sponsor.
ClinicalTrials.govLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Maria Panzeri, PHD student contact

00393337422526

maria.panzeri@unimib.it

Simona Fumagalli, PHD contact

00393935554696

simona.fumagalli@unimib.it

Sara Ornaghi, PHD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Rebozo and Maternal Procedures in people with Persistent Occiput Posterior Position During Labor, run by University of Milano Bicocca at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria Panzeri, PHD student (00393337422526, maria.panzeri@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06887634, which also lists 81 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.