Maternal Maneuvers During Prolonged Labor

Not Applicable

Recruiting

• Conditions: Labor Stage, First; Prolonged Labor
• Interventions: Other: Circuit of maternal position changes during labor

• Registration Number: NCT06636149
• Lead Sponsor: Washington University School of Medicine

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.
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Detailed Description

To date, there is an absence of data on intrapartum maternal position changes' efficacy or whether a specific circuit of intrapartum maneuvers is effective. We hypothesize that a nurse-informed circuit of positional maneuvers in protracted labor will significantly decrease the first stage of labor. The objective of this randomized control trial will be to as...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Study First Posted: 2024-10-10
• Status Verified: 2024-12
• Study Start: 2024-12-10
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2026-04-01
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

• English-speaking patients
• Singleton, vertex pregnancies
• 34 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Circuit Intervention Arm	Circuit of maternal position changes during labor	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

Primary Outcome Measures

Name	Time	Method
First stage of labor duration	From enrollment until delivery	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.

Secondary Outcome Measures

Name	Time	Method
Length of latent labor	Admission until active labor (cervix 6cm or greater) or delivery	Time from initial cervical exam for any patient admitted with spontaneous labor or time from first induction agent administration for inductions of labor until cervical exam with dilation of 6cm or more, or undergoes delivery.
Length of second stage of labor	10cm of cervical dilation to delivery	Time from cervical dilation of 10cm until delivery
Time from randomization to delivery	Time from randomization to delivery	Time from when patient randomized into study until delivery
Time from randomization to second stage of labor	Time from randomization until patient achieves 10cm cervical dilation	Time from randomization until patient achieves 10cm cervical dilation
Composite maternal morbidity	Enrollment to postpartum discharge	Includes: postpartum hemorrhage, maternal blood transfusion, severe perineal laceration (3rd and 4th degree), ICU admission, and maternal death
Composite Neonatal Morbidity	From delivery until neonatal discharge or 1 month of life (whichever comes first)	Includes: neonatal death, respiratory distress defined as need for respiratory support within 72 hours after birth and consisting of one or more of the following: the use of continuous positive airway pressure (CPAP) or high-flow nasal cannula for at least 2 consecutive hours, supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at lea...
Cesarean section indication	Enrollment to delivery	Reason patient underwent cesarean delivery
Length of active labor	Time from 6cm of cervical dilation to 10cm of cervical dilation or delivery	Time from cervical exam of 6cm or more until patient has cervical dilation of 10cm or delivery
Length of labor	Enrollment to delivery	Time from initial cervical exam for any patient admitted with spontaneous labor or time from first induction agent administration for inductions of labor until delivery
Mode of delivery	Enrollment to delivery	Type of delivery patient undergoes: vaginal delivery, operative vaginal delivery, or cesarean delivery

Trial Locations

Locations (1)

Washington University Medicine; 🇺🇸 Saint Louis, Missouri, United States