Maternal Maneuvers During Prolonged Labor
Part of paid clinical trials in Saint Loius, Missouri.
- Sponsor
- Washington University School of Medicine
- Study ID
- NCT06636149
- Status
- Recruiting
Conditions
- Labor Stage, First
- Prolonged Labor
Eligibility Criteria
- Sex
- FEMALE
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Circuit of maternal position changes during labor — OTHERThe 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
Study Details
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.
Key Dates
- Start date
- Dec 10, 2024
- Status verified
- Mar 2026
- Primary completion
- Apr 1, 2028
- Completion
- May 31, 2028
Study Design
- Enrollment
- 82 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Circuit Intervention ArmThe 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
- No Intervention: Control ArmPatients 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.
Primary Outcome Measure
First stage of labor duration [ Time Frame: From enrollment until delivery ]
Central Contacts
- Drew Hensel Maternal Fetal Medicine Fellow, MD314-718-0839
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Washington University Medicine | Saint Loius | Missouri | 63110 | Nandini Raghuraman, MD |
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