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NCT05881629 · ClinicalTrials.gov registry record · NA
Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery
A NA study of Labor Complication and Labor Dystocia, sponsored by Women and Infants Hospital of Rhode Island.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT05881629: Recruiting NA study of Labor Complication and Labor Dystocia, sponsored by Women and Infants Hospital of Rhode Island.
NCT05881629 is a NA study of Labor Complication and Labor Dystocia that is actively recruiting participants, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 200 participants, below the 277-participant average among 5 other Labor Complication trials with a reported enrollment target (28% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05881629, a NA study of Labor Complication and Labor Dystocia, is actively recruiting participants, sponsored by Women and Infants Hospital of Rhode Island.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
The combined rate of cesarean and instrumental vaginal deliveries in each study group
Conditions Studied
Interventions
- BEHAVIORAL Maternal position change to side-lying lateral with peanut ball
- BEHAVIORAL Free maternal position
Study Locations (1)
Rhode Island
- Women and Infant's Hospital of Rhode Island - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-05-01 |
| Est. Completion | 2026-09-01 |
| Phase | NA |
What NCT05881629 shows while recruiting
NCT05881629 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 277-participant average among 5 other Labor Complication trials with a reported enrollment target (28% lower).
The record links to 3 conditions, with Labor Complication appearing as the primary indexed condition, and to 2 interventions - of which Maternal position change to side-lying lateral with peanut ball is the first listed.
NCT05881629 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT05881629 about?
NCT05881629 is a clinical study titled "Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery". 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 ...
What is the current status of trial NCT05881629?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2024-05-01. Estimated completion is 2026-09-01.
What conditions does trial NCT05881629 study?
This clinical trial studies the following conditions: Labor Complication, Labor Dystocia, Cesarean Delivery Affecting Fetus.
What interventions are being tested in trial NCT05881629?
The interventions under investigation include: Maternal position change to side-lying lateral with peanut ball (BEHAVIORAL), Free maternal position (BEHAVIORAL).
Who is sponsoring clinical trial NCT05881629?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05881629 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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