Maternal Positioning for Fetal Occiput Posterior Position

Recruiting in New Hyde Park (>99 mi)

Overseen By Emma Brenner, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Under 18, Unable to consent, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Until 10 cm cervical dilation

465 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Valerie Schulz, MD

Principal Investigator

Northwell Health

Sarah Pachtman, MD

Principal Investigator

Northwell Health

Eligibility Criteria

This trial is for women over 18 years old, at full term (37+ weeks pregnant) with a single baby in head-down position facing up ('sunny side up') when admitted for labor. They must be less than 10cm dilated and have mild pain (score of ≤3/10). Excluded are those under 18, unable to consent, in advanced labor (>10cm), wanting cesarean delivery or with complications like fetal growth restriction or abnormal presentations.

Inclusion Criteria

I am admitted to LIJ or NSUH for labor.

>/=37 weeks gestation (full term) with a viable singleton intrauterine pregnancy noted to be cephalic presentation in the OP position at the time of admission as noted on bedside ultrasound

I am a woman aged 18 or older.

Exclusion Criteria

I am unable to give consent by myself.

all women with pregnancies noted to have IUGR, fetal anomalies, malpresentation (i.e. breech), multiple gestations or fetuses not in the OP position at time of admission will be excluded.

I am not in advanced labor, do not have a nonviable pregnancy, and my pain is manageable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Upon admission

1 visit (in-person)

Treatment

Participants are assigned to different maternal positioning strategies during the first stage of labor to correct fetal OP to OA position

Until 10 cm cervical dilation

Continuous monitoring during labor

Follow-up

Participants are monitored for delivery outcomes and any complications

From delivery to discharge

In-person monitoring

Treatment Details

Interventions

• Maternal Positioning

Trial Overview The study tests if certain maternal positions during the first stage of labor can turn babies from a 'sunny side up' position to a more favorable one for vaginal birth. Women will be randomly placed into three groups: control group choosing any position, and two experimental groups using specific positioning strategies based on fetal movement.

Participant Groups

Group I: C Experimental Treatment 1 Intervention

Group C, will be placed in the same position but opposite that of which fetal kicks are felt.

Group II: B Experimental Treatment 1 Intervention

Group B will be placed in a dorsal recumbent, modified sims position on the side of fetal movement.

Group III: A Active Control 1 Intervention

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+