Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of … (NCT05881629) | Clinical Trial Compass
RecruitingNot Applicable
Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery
United States200 participantsStarted 2024-05-01
Plain-language summary
The goal of this randomized trial is to test if changing a person's position in labor can increase the chances of delivering their baby vaginally.
Specifically, it aims to answer the questions:
* In fetuses who are facing upwards (occiput posterior, OP) or sideways (occiput transverse, OT) during labor, does changing the patient's position during active labor to a side-lying posture with a peanut ball increase the chances of them having a successful, spontaneous vaginal delivery?
* Does changing the patient's position in active labor affect the position of the baby at the time of delivery?
* Do intentional position changes in labor impact patient-perceived autonomy during their labor and delivery experience?
Participants will:
* Receive an ultrasound during labor to determine the position of their baby
* Be asked to adopt a specific position in labor (side-lying with peanut ball) if they are randomized to the study group
* Receive additional ultrasounds during labor to assess their baby's position
* Fill out a questionnaire about their labor experience following the delivery of their baby
Who can participate
Age range
18 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:
* Maternal age \>18
* Term gestation (\>37 weeks)
* Singleton pregnancy
* Spontaneous or induced active labor (cervical dilation 6-9cm)
* Epidural anesthesia
* Cephalic fetal presentation, OP/OT position diagnosed by bedside ultrasound
* Continuous external fetal monitoring
* Ability to consent
Exclusion Criteria:
* Multiple gestations
* Unanesthetized labor
* Known fetal anomalies
* Known intrauterine fetal demise
* Inability to consent
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.
1This trial is focused on diagnosing and correcting fetal malposition during active labor — if I'm already in labor and my baby is in a difficult position, how quickly could I realistically be evaluated and enrolled, and would that timing affect my care?
2The study is measuring whether early diagnosis and intervention for fetal malposition can reduce the rate of operative deliveries like cesarean sections or forceps use — based on what my own labor situation looks like, does my doctor think this kind of intervention would realistically apply to me?
3Since this trial is listed as 'Phase NA,' meaning it's not testing a new drug but rather a clinical approach or strategy, what exactly would be done differently compared to standard labor management if I participated?
4If a fetal malposition is identified during my labor, what are the current standard-of-care options my hospital already offers, and how does participating in this trial differ from what I would receive anyway?
5Are there any risks specific to the hands-on interventions used in this study to correct fetal position during active labor that I should weigh against the potential benefit of avoiding a cesarean delivery?
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.
What they're measuring
1
Operative Delivery Rate
Timeframe: Enrollment in active labor through delivery, on average 12 hours