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

ConditionPersistent Occiput Posterior Position During Labor
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Milano Bicocca

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Rebozo and Maternal Procedures

    Other intervention

    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

    Other intervention

    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.

Treatment groups

578 Participants
are divided into 2 treatment groups
Group A: Rebozo and Maternal ProceduresActive comparator 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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".

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".
2

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

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
3

Duration of labor

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

Time frame
From the diagnosis of active first stage of labor up birth.
4

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

Time frame
At birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Milano Bicocca

Lead sponsor

Fondazione IRCCS San Gerardo dei Tintori

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: