Maternal Position Change for Labor Complications

Overseen By Alexis Gimovsky, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Women and Infants Hospital of Rhode Island

Disqualifiers: Multiple gestations, Fetal anomalies, others

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether changing a person's position during labor can increase the chances of vaginal delivery. It focuses on individuals whose babies face upwards or sideways during labor to determine if lying on their side with a peanut-shaped cushion (known as a peanut ball) helps. Participants will undergo ultrasounds to check the baby's position and will share their labor experiences through a questionnaire. This study suits those in labor with an epidural and a baby positioned head down but facing the wrong way, as diagnosed by ultrasound. As an unphased trial, it offers participants the chance to contribute to valuable research that could improve labor outcomes for many.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this maternal position change is safe for labor?

Research shows that using a peanut ball during labor is safe and helpful. Studies have found that the peanut ball can shorten labor and reduce the need for a cesarean section for women with an epidural. One study suggested that using this ball can also lower pain during labor.

No reports of serious side effects from using the peanut ball during labor indicate it is well-tolerated by most people. For those considering joining a trial involving the peanut ball, the evidence so far shows it is a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how changing the mother's position during labor, specifically to a side-lying position with the help of a peanut ball, might affect labor complications. Unlike current methods that rely on medical interventions like epidurals or medications to manage labor, this technique is non-invasive and uses gravity and positioning to potentially ease the baby's descent and reduce labor time. This approach could offer a simple, low-cost, and drug-free alternative for improving labor outcomes, which is why it has captured the interest of the research community.

What evidence suggests that changing maternal position during labor is effective for increasing vaginal delivery rates?

Research has shown that using a peanut ball during labor can increase the likelihood of a vaginal birth. One study found an 11% increase in successful vaginal deliveries with the use of a peanut ball. It can also shorten the first stage of labor and reduce the number of C-sections for women who receive epidurals. In this trial, participants in the side-lying peanut ball group will adopt a side-lying, lateral position with a peanut ball, potentially offering these benefits. These findings suggest that changing positions with a peanut ball during labor could benefit both mother and baby. ^{1 2 3 4 6}

Who Is on the Research Team?

Alexis Gimovsky, MD

Principal Investigator

Women and Infant's Hospital of Rhode Island

Are You a Good Fit for This Trial?

This trial is for individuals over 18 years old in active labor (6-9cm dilation) with a single baby at term (>37 weeks), who have an epidural and whose baby is facing upwards or sideways. The baby must be head down, monitored continuously, and the mother able to consent.

Inclusion Criteria

Cephalic fetal presentation, OP/OT position diagnosed by bedside ultrasound

Term gestation (>37 weeks)

Singleton pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Labor Intervention

Participants receive an ultrasound to determine fetal position and may be asked to adopt a side-lying position with a peanut ball if randomized to the study group

12 hours

In-person during labor

Delivery and Immediate Postpartum

Participants deliver their baby and are monitored for operative delivery rates, blood loss, and neonatal outcomes

24 hours

In-person during and after delivery

Follow-up

Participants are monitored for safety and effectiveness after delivery, including NICU admission rates and postpartum recovery

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Maternal position change to side-lying lateral with peanut ball

Trial Overview The study tests if changing the mother's position to side-lying with a peanut ball during active labor can help deliver the baby vaginally. It also examines how this affects the baby's position at delivery and the mother's sense of control during childbirth.

How Is the Trial Designed?

Group I: Side-lying peanut ball group Experimental Treatment 1 Intervention

Participants randomized to this group will be asked to adopt a side-lying, lateral position on the ipsilateral side of the fetal spine. A peanut ball will be positioned between the participant's legs while in this position. They will be asked to maintain this position for 60 minutes.

Group II: Control group Placebo Group 1 Intervention

Participants randomized to this group will be able to adopt any position of their choosing during the 60-minute study period. They will not be able to use a peanut ball during this time.

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9727314/

Effectiveness of a peanut ball device during labour on ... The current study aims to evaluate the effectiveness of the peanut ball device during labour on maternal and neonatal outcomes and assess the stress response ...

2. ajog.org ajog.org/article/S0002-9378(23)00115-1/fulltext

Birthing balls to decrease labor pain and peanut ... A recent meta-analysis showed that the use of the birthing ball in labor significantly reduces maternal pain in labor by 1.7 points on a standard visual analog ...

3. europeanjournalofmidwifery.eu europeanjournalofmidwifery.eu/Investigation-of-the-effects-of-peanut-ball-during-labor-An-updated-systematic-review,201345,0,2.html

Investigation of the effects of peanut ball during labor This study revealed a statistically significant 11% increase in the probability of vaginal birth among participants assigned to the peanut ball ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05881629

Early Diagnosis and Intervention for Fetal Malposition in ... The goal of this randomized trial is to test if changing a person's position in labor can increase the chances of delivering their baby vaginally.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11907655/

Investigation of the effects of peanut ball during labor The peanut birth ball reduces the first stage of labor duration, and lowers cesarean rates in women with epidural analgesia.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937823001151

Birthing balls to decrease labor pain and peanut ... A recent meta-analysis showed that the use of the birthing ball in labor significantly reduces maternal pain in labor by 1.7 points on a standard visual analog ...