Maternal Maneuvers During Prolonged Labor

NCT06636149 | Recruiting DMC

• 1 other identifier: 202408190
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot, randomized control trial will test whether or not a specific circuit of position changes improves maternal outcomes in cases of prolonged labor. Patient who have prolonged labor will be approached for consent and randomization to one of two study groups: circuit intervention against routine standard of care position changes. 82 patients will be enrolled in the study. Exclusion criteria will include: any uterine infection prior to randomization, magnesium sulfate treatment, major fetal anomalies, BMI ≥50, non-reassuring fetal status prior to randomization, or any maternal diagnosis that precludes safety or feasibility of the circuit of maternal position changes. The 3 aims of the study will include: the outcome that the circuit of position changes has on the duration of the first stage of labor, maternal and neonatal morbidity, and maternal satisfaction.

Conditions

Labor Stage, First; Prolonged Labor

Keywords

Circuit; Position changes; Labor; Prolonged labor; Labor dystocia

Outcome Measures

Primary Outcomes (1)

• First stage of labor duration

  Time from first cervical exam in spontaneous labor or first induction agent administration for induction of labor until patient has achieved cervical dilation of 10cm.

  From enrollment until delivery

Secondary Outcomes (10)

• Mode of delivery

  Enrollment to delivery

• Cesarean section indication

  Enrollment to delivery

• Length of labor

  Enrollment to delivery

• Length of active labor

  Time from 6cm of cervical dilation to 10cm of cervical dilation or delivery

• Length of latent labor

  Admission until active labor (cervix 6cm or greater) or delivery

Study Arms (2)

Circuit Intervention Arm

EXPERIMENTAL

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

Other: Circuit of maternal position changes during labor

Control Arm

NO 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.

Interventions

Circuit of maternal position changes during labor OTHER

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

Circuit Intervention Arm

Eligibility Criteria

• Age: 12 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking patients
• Singleton, vertex pregnancies
• weeks' gestation or later
• Admitted to Labor and Delivery in spontaneous labor or for an induction of labor
• Prolonged labor course as defined by: cervical dilation less than 6 cm after 8 hours or more of ruptured membranes (spontaneous or artificial) and oxytocin infusion, or cervical dilation 6 cm or more and less than 1-cm cervical dilation change over 2 hours or more with ruptured membranes and oxytocin infusion

You may not qualify if:

• Intraamniotic infection prior to randomization
• Magnesium sulfate treatment
• Major fetal anomalies
• BMI ≥50
• Non-reassuring fetal status prior to randomization
• Any maternal diagnosis that precludes safety or feasibility of intrapartum circuit of maternal position changes

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Barnes-Jewish Hospital: collaborator
• The Foundation for Barnes-Jewish Hospital: collaborator

Study Sites (1)

Washington University Medicine

Saint Loius, Missouri, 63110, United States

RECRUITING

Related Publications (8)

• Carbonne B, Benachi A, Leveque ML, Cabrol D, Papiernik E. Maternal position during labor: effects on fetal oxygen saturation measured by pulse oximetry. Obstet Gynecol. 1996 Nov;88(5):797-800. doi: 10.1016/0029-7844(96)00298-0.

  PMID: 8885916 RESULT

• Gupta JK, Sood A, Hofmeyr GJ, Vogel JP. Position in the second stage of labour for women without epidural anaesthesia. Cochrane Database Syst Rev. 2017 May 25;5(5):CD002006. doi: 10.1002/14651858.CD002006.pub4.

  PMID: 28539008 RESULT

• Roberts JE, Mendez-Bauer C, Wodell DA. The effects of maternal position on uterine contractility and efficiency. Birth. 1983 Winter;10(4):243-9. doi: 10.1111/j.1523-536x.1983.tb01433.x. No abstract available.

  PMID: 6556913 RESULT

• Mendez-Bauer C, Arroyo J, Garcia Ramos C, Menendez A, Lavilla M, Izquierdo F, Villa Elizaga I, Zamarriego J. Effects of standing position on spontaneous uterine contractility and other aspects of labor. J Perinat Med. 1975;3(2):89-100. doi: 10.1515/jpme.1975.3.2.89.

  PMID: 1185484 RESULT

• Tussey CM, Botsios E, Gerkin RD, Kelly LA, Gamez J, Mensik J. Reducing Length of Labor and Cesarean Surgery Rate Using a Peanut Ball for Women Laboring With an Epidural. J Perinat Educ. 2015;24(1):16-24. doi: 10.1891/1058-1243.24.1.16.

  PMID: 26937158 RESULT

• Hickey L, Savage J. Effect of Peanut Ball and Position Changes in Women Laboring With an Epidural. Nurs Womens Health. 2019 Jun;23(3):245-252. doi: 10.1016/j.nwh.2019.04.004. Epub 2019 May 9.

  PMID: 31077640 RESULT

• Harvey S, Rach D, Stainton MC, Jarrell J, Brant R. Evaluation of satisfaction with midwifery care. Midwifery. 2002 Dec;18(4):260-7. doi: 10.1054/midw.2002.0317.

  PMID: 12473441 RESULT

• McCoy JA, Walheim L, McCabe MG, Levine LD. Efficacy of Propranolol to Reduce Cesarean Delivery in Prolonged Labor: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jul 1;142(1):71-79. doi: 10.1097/AOG.0000000000005232. Epub 2023 Jun 7.

  PMID: 37290102 RESULT

MeSH Terms

Conditions

Dystocia

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Drew Hensel Maternal Fetal Medicine Fellow, MD

CONTACT

314-718-0839; dhensel@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Fellow - Maternal Fetal Medicine

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)