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 — 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

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 Arm
    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
  • No Intervention: Control Arm
    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.

Primary Outcome Measure

First stage of labor duration [ Time Frame: From enrollment until delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University MedicineSaint LoiusMissouri63110
Drew Hensel, MD
314-718-0839
Nandini Raghuraman, MD

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