Maternal Maneuvers During Prolonged Labor (NCT06636149) | Clinical Trial Compass
RecruitingNot Applicable
Maternal Maneuvers During Prolonged Labor
United States82 participantsStarted 2024-12-10
Plain-language 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.
Who can participate
Age range
12 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.