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Clinical trialNCT05307393UnknownInterventional

Maternal Positioning to Correct Fetal Occiput Posterior

SponsorNorthwell HealthEnrollment465Obstetric Complication
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

In evaluating a patient's ability to have a normal vaginal delivery, a practitioner must consider three factors. Commonly referred to as the three P's, these include Power (contractions), Passage (pelvis and soft tissue) and passenger (baby). Power can be controlled through induction and augmentation agents. Passage is determined by the women's body habitus. Passenger includes the baby's estimated fetal weight (EFW) and position. Throughout the history of obstetrics, the baby's position has been a factor that has acted as a strong predictor of a woman's ability to deliver vaginally. Several researchers have looked into the percentage of babies born in the Occiput Anterior (fetus facing down) vs. Occiput Posterior (fetus facing up aka "sunny side up") position. Studies have shown that the majority of babies are born in OA position and that the finding of an OA positioned baby is associated with a greater likelihood of a successful vaginal delivery. OP position is associated with higher risk of 3rd and 4th degree perineal lacerations, operative delivery (vacuum/forceps) and cesarean section. Therefore OP position poses a higher risk of morbidity to the patient and fetus. Multiple studies exist in the obstetrics and midwifery literature regarding maternal positioning to correct fetal malposition. Many of these studies have shown no significance and those that do have generated conflicting results and are consistently lacking in power. The aim of this prospective study is to determine if maternal positioning to either the side of fetal movement (contralateral/opposite to the fetal spine) or opposite of the side of fetal movement (ipsilateral to the fetal spine) during the first stage of labor is associated with correction of fetal OP to OA position. Upon admission to labor and delivery, following an initial ultrasound to confirm fetal OP position, women in this study will be randomly assigned to one of three groups; one control (Group A), and two experimental (Groups B and C) groups. Those assigned to Group A will be allowed to remain in any position they chose during their labor and delivery course. Group B will be placed in a dorsal recumbent, modified sims position on the side of fetal movement. Group C, will be placed in the same position but opposite that of which fetal kicks are felt. Subjects in the experimental group will be asked to remain in these positions throughout the majority of their labor and delivery course, up until the second stage of labor (10 cm dilated). They will be allowed to change positions for up to 10 min per hour for maternal comfort and any fetal resuscitation efforts. Anything longer than this will be considered a deviation from the protocol and will be documented as such, but all necessary intervention for fetal well-being will be allowed including changes in maternal position for longer than 10 minutes. Once a cervical dilation of 10cm is achieved all study interventions will be discontinued. Peanut balls and manual rotational maneuvers will not be allowed as they are considered confounding factors which may individually affect fetal position. Data will be collected from the hospital record. This data will include: maternal age, BMI, race, maternal medical complications, delivery type, laceration, fetal position at delivery, dilation on admission and weight of the baby.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Long Island Jewish Medical Center

    New Hyde Park, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Jan 2024
Primary completion
1 Jan 2025
Completion
1 Jan 2025
Last update posted
8 Mar 2023
Registered enrollment
465
Registry id
NCT05307393

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.