Maternal Maneuvers During Prolonged Labor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age12+
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Intraamniotic infection prior to randomization
Magnesium sulfate treatment
Major fetal anomalies
BMI ≥50
Trial design
Design model
Parallel
Treatments tested in this trial
Circuit of maternal position changes during labor
Other interventionThe 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
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Circuit Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions
Trial outcomes
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.
Time frame
From enrollment until deliverySecondary outcomes
1
Mode of delivery
Type of delivery patient undergoes: vaginal delivery, operative vaginal delivery, or cesarean delivery
Time frame
Enrollment to delivery2
Cesarean section indication
Reason patient underwent cesarean delivery
Time frame
Enrollment to delivery3
Length of labor
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
Time frame
Enrollment to delivery4
Length of active labor
Time from cervical exam of 6cm or more until patient has cervical dilation of 10cm or delivery
Time frame
Time from 6cm of cervical dilation to 10cm of cervical dilation or deliverySponsors and contacts
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Washington University School of Medicine
Lead sponsor
Barnes-Jewish Hospital
Collaborator
The Foundation for Barnes-Jewish Hospital
Collaborator
Source ClinicalTrials.gov