Maternal Position Changes for Prolonged Labor

(CIRCUIT Trial)

Recruiting at 1 trial location

Overseen By Drew Hensel Maternal Fetal Medicine Fellow, MD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: Oxytocin

Must not be taking: Magnesium sulfate

Disqualifiers: Uterine infection, Major fetal anomalies, others

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

Compensation: Varies

Number of Visits: 2

82 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if changing a mother's position during prolonged labor can improve outcomes for both mother and baby. Participants will be randomly assigned to one of two groups: one will follow a specific set of position changes, known as the Circuit of Maternal Position Changes, while the other will receive standard care with regular position changes. Researchers seek to discover if these specific movements can shorten the first stage of labor, improve health outcomes, and increase maternal satisfaction. Expectant mothers experiencing prolonged labor who meet specific criteria, such as having a single baby in a head-down position, might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding how maternal position changes can enhance labor experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving magnesium sulfate treatment, you would be excluded from participating.

What prior data suggests that this circuit of maternal position changes is safe for prolonged labor?

Research shows that changing positions often during labor can enhance comfort and assist in positioning the baby. Studies indicate that these movements are generally safe, and most women manage them well. This trial focuses on a specific routine of position changes, where participants move through different positions every two hours. Although specific safety data for this exact routine is not yet available, changing positions during labor is a common and usually safe practice.

The routine remains flexible. If any issues arise, such as concerns about the baby's well-being, adjustments to the plan can be made. Continuous monitoring will ensure safety. While detailed safety data for this specific routine is not yet available, changing positions during labor is generally considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for prolonged labor focus on medical or surgical interventions, like administering oxytocin to stimulate contractions or performing a C-section. This trial is unique because it explores a non-invasive method using a specific circuit of maternal position changes. Researchers are excited about this approach because it could offer a natural way to progress labor without medication, potentially reducing the need for more invasive procedures. Additionally, the method includes continuous fetal monitoring, ensuring the safety of both mother and baby throughout the process. The hope is to find out if these position changes can effectively shorten labor duration and improve outcomes for mothers experiencing prolonged labor.

What evidence suggests that this circuit of maternal position changes is effective for prolonged labor?

Research has shown that changing positions during labor can be beneficial. Studies have found that certain positions can shorten the second stage of labor. For instance, positions that allow flexibility in the lower back can reduce labor time. Additionally, different positions can alter the pelvic space, potentially aiding smoother labor. This trial will test a specific circuit of maternal position changes, with participants in the Circuit Intervention Arm undergoing these changes every 2 hours. Although direct evidence for this specific series of position changes is limited, the underlying concepts are supported by existing research. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for English-speaking patients with a single baby in the correct head-down position, who are at least 34 weeks pregnant. They must be experiencing prolonged labor, defined as slow cervical dilation despite ruptured membranes and oxytocin use. Those with uterine infections, on magnesium sulfate treatment, having major fetal anomalies or extremely high BMI (≥50), non-reassuring fetal status before randomization, or any condition that makes the circuit unsafe cannot join.

Inclusion Criteria

I am English-speaking, over 34 weeks pregnant, in labor, and my labor is not progressing as expected.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Upon admission to labor and delivery or diagnosis of protracted labor

1 visit (in-person)

Randomization and Intervention

Participants are randomized to either the circuit intervention arm or the control arm. The intervention cohort undergoes the circuit of position changes every 2 hours, repeated up to 3 times or until the second stage of labor is achieved.

From randomization until delivery

Continuous monitoring during labor

Postpartum Follow-up

Participants are monitored for maternal and neonatal outcomes, and complete a maternal satisfaction survey regarding their labor experience.

From delivery until postpartum discharge

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Circuit of maternal position changes

Trial Overview The study compares a specific set of maternal position changes to routine care during prolonged labor. It aims to see if these movements can shorten the first stage of labor and improve outcomes and satisfaction for both mother and baby. Participants will be randomly assigned to one of two groups: those performing the circuit or receiving standard care.

How Is the Trial Designed?

Group I: Circuit Intervention Arm Experimental Treatment 1 Intervention

The intervention cohort will undergo the circuit of position changes every 2 hours. The circuit will be repeated up to 3 times or until the second stage of labor is achieved, delivery occurs, or labor arrest diagnosis is made. Participants will be considered as adherent to intervention arm if they undergo one complete circuit of maneuvers. Nurses will keep patients on continuous fetal monitoring during the circuit of position changes. Any persistent non-reassuring fetal status in one position of the circuit will prompt progression to the next position in the circuit. The planned circuit of maneuvers will be: 10-minutes of side-lying release on one side 10-minutes of side-lying release on other side 10-minutes of open-knee chest 10-minutes of shaking apples 20-minutes of flying cowgirl on one side 20-minutes of flying cowgirl on opposite side as position 5 20-minutes of running man on same side as position 5 20-minutes of running man on opposite side as position 5

Group II: Control Arm Active Control 1 Intervention

Patients randomized to the control arm will have their labor courses managed per current best practice recommendations. This will include nurse or patient facilitated position changes per the discretion of the patient's clinical care team. Routine position changes allowed in this control group will include walking, sitting, squatting, thrones, supine, hands and knees, and lateral decubitus with or without peanut ball. No positions in the circuit intervention group will be permitted to be used in the control group. Any circuit positions used in the control group will be tracked and documented.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Barnes-Jewish Hospital

Collaborator

Trials

36

Recruited

10,300+

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials

43

Recruited

6,600+

Published Research Related to This Trial

In a study of 58 women during cervical dilatation from 6 to 8 centimeters, adopting a sitting position significantly reduced labor pain intensity compared to a supine position, particularly for lower back pain.

The sitting position resulted in clinically meaningful reductions in pain scores, with the most notable relief observed in lumbar pain during contractions, indicating it could be an effective strategy for pain management in labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between the parturient's positions and perceptions of labor pain intensity. Adachi, K., Shimada, M., Usui, A.[2019]

A survey of 206 pregnant women revealed that while 76% were aware of fetal malposition during labor, only 28% knew that maternal posture could help correct it, indicating a need for increased awareness and education on this topic.

Although 86% of women expressed interest in participating in labor research, only 37% were willing to join a randomized controlled trial, with comfort concerns and the need for partner consultation being significant barriers to participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnant women's views on the acceptability, enablers, and barriers of participation in a randomized controlled trial of maternal posture for fetal malposition in labor. Barrowclough, J., Kool, B., Crowther, CA.[2022]

Maternal positioning during labor is a valuable, noninvasive intervention that can enhance comfort and promote labor progress, as women often instinctively change positions for relief.

The review identifies six mechanisms by which changing maternal positions can help prevent or correct dystocia, highlighting the importance of mobility in the birthing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal positioning to prevent or alleviate dystocia in labor. Fenwick, L., Simkin, P.[2019]

The traditional dorsal position for labor and birth may have disadvantages, as alternative positions like lateral and upright can enhance uterine contractions.

Upright positions not only improve contraction quality but also lead to shorter and more comfortable labors, highlighting the need for educating women about these benefits and supporting them in adopting these positions during childbirth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal position during labor and birth: a reassessment. McKay, SR.[2019]

Upright positions during labor offer several benefits, including improved physiological and psychosocial outcomes, as discussed in the context of historical practices and modern obstetric influences.

The paper provides recommendations for healthcare providers to facilitate the use of upright positions during labor, highlighting the importance of integrating these practices into current labor and delivery protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positioning during the second stage of labor: moving back to basics. Shermer, RH., Raines, DA.[2019]

In a study analyzing 116 intrauterine pressure records, the sitting position during labor was found to significantly elevate resting and bearing down pressures compared to the supine position, particularly benefiting nulliparous women during the second stage of labor.

The sitting position not only increased bearing down pressure but also led to a shorter duration of the second stage of labor for nulliparas and the dilation period for multiparas, suggesting that maternal position can influence labor efficiency without affecting uterine contractility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sitting position on uterine activity during labor. Chen, SZ., Aisaka, K., Mori, H., et al.[2009]

A randomized clinical trial is currently evaluating the effectiveness of maternal positioning techniques in managing occipito-posterior (OP) fetal head positions during labor, involving 438 women at a major maternity unit in Switzerland.

If successful, these techniques could significantly reduce complications associated with persistent OP positions, such as prolonged labor and the need for emergency cesarean sections, while being well-accepted by women and easy to implement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal positioning to correct occipito-posterior fetal position in labour: a randomised controlled trial. Guittier, MJ., Othenin-Girard, V., Irion, O., et al.[2021]

In a study of 264 women during labor, the incidence of severe perineal trauma was very low at 0.75%, with cases occurring only in younger nulliparous women, indicating that severe trauma is rare in this population.

The maternal position during the second stage of labor did not significantly affect the risk of perineal trauma, but being white or a first-time mother (nulliparous) increased the likelihood of experiencing perineal tears by 3.90 and 2.90 times, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineal Trauma in a Low-risk Maternity with High Prevalence of Upright Position during the Second Stage of Labor. Peppe, MV., Stefanello, J., Infante, BF., et al.[2022]

Maternal movement and position changes during labor are crucial for facilitating progress, but modern interventions like epidurals and fetal monitoring have made these changes less common, potentially leading to complications like dystocia.

The article reviews historical research and presents six physiological principles to guide effective maternal positioning strategies, especially before and after receiving epidural anesthesia, to improve labor outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming the challenges: maternal movement and positioning to facilitate labor progress. Zwelling, E.[2022]

A study involving 100 healthy pregnant women showed that specific maternal postures can effectively rotate a fetus from a posterior or transverse position to an optimal anterior position, with significant results (p < 0.000).

All four tested postures were similarly effective, and the Sims posture was particularly successful in maintaining the anterior position when performed correctly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing, maternal postures, and fetal position. Andrews, CM., Andrews, EC.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06636149

Maternal Maneuvers During Prolonged Labor This pilot, randomized control trial will test whether or not a specific circuit of position changes improves maternal outcomes in cases of prolonged labor.

2. withpower.com withpower.com/trial/phase-labor-first-stage-9-2024-c50f0

Maternal Position Changes for Prolonged Labor This pilot, randomized control trial will test whether or not a specific circuit of position changes improves maternal outcomes in cases of prolonged labor.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6894325/

Effect of maternal birth positions on duration of second ... The result suggested a reduction in duration of second stage of labor among women in a flexible sacrum birthing position, with a mean duration from 3.2–34.8.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8678923/

Evaluating the effects of maternal positions in childbirth The purpose of this study is to conduct an overview of Cochrane systematic reviews (SRs) evaluating the effects of maternal positions in childbirth.

5. researchgate.net researchgate.net/publication/348039968_Effect_of_the_birthing_position_on_its_evolution_from_a_biomechanical_point_of_view

Effect of the birthing position on its evolution from a ... Conclusions Globally, the results obtained allow to conclude that different birthing positions lead to changes in the female pelvic space, so ...

6. meddatax.com meddatax.com/clinical-trials/NCT06636149

Maternal Maneuvers During Prolonged Labor This pilot, randomized control trial will test whether or not a specific circuit of position changes improves maternal outcomes in cases of prolonged labor.

7. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/02/approaches-to-limit-intervention-during-labor-and-birth

Approaches to Limit Intervention During Labor and Birth Frequent position changes during labor to enhance maternal comfort and promote optimal fetal positioning can be supported as long as adopted positions allow ...