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NCT03504670 · ClinicalTrials.gov registry record · NA
Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 86
- Enrollment target
NCT03504670: Completed NA study, sponsored by University of Alabama at Birmingham.
NCT03504670 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 86 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03504670, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 86 participants
- Enrollment target
Study Summary
Artificial rupture of membranes (amniotomy) is a commonly used technique to safely induce and augment labor. It has been shown to reduce the duration of spontaneous and induced labor in term patients (≥37 weeks' gestation). The utility of amniotomy in preterm patients (\<37 weeks' gestation) undergoing medically-indicated induction of labor is unknown. However, it remains a commonly used strategy. We will conduct a trial comparing early amniotomy versus late amniotomy during medically-indicated induction of labor between 23.0 and 35.6 weeks gestation. Women will be randomized to early or late amniotomy after the obstetrician has decided to induce labor for a medical indication. We hypothesize that more women in the early amniotomy group will require cesarean delivery, and the duration of labor will increase in the early amniotomy group.
Primary Outcome
Proportion of women requiring cesarean delivery
Interventions
- PROCEDURE Early Amniotomy
- PROCEDURE Late Amniotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2018-11-14 |
| Est. Completion | 2021-01-13 |
| Phase | NA |
What the finished NCT03504670 record still lists
NCT03504670 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Early Amniotomy is the first listed.
NCT03504670 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03504670 about?
NCT03504670 is a clinical study titled "Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial". Artificial rupture of membranes (amniotomy) is a commonly used technique to safely induce and augment labor. It has been shown to reduce the duration of spontaneous and induced labor in term patients (≥37 weeks' gestation). The utility of amniotomy in preterm patients (\<37 weeks' gestation) undergo...
What is the current status of trial NCT03504670?
This trial is currently completed. It is a NA study. The enrollment target is 86 participants. The study started on 2018-11-14. Estimated completion is 2021-01-13.
What interventions are being tested in trial NCT03504670?
The interventions under investigation include: Early Amniotomy (PROCEDURE), Late Amniotomy (PROCEDURE).
Who is sponsoring clinical trial NCT03504670?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03504670's enrollment target sits among peer trials
86 976th of 2000 higher than 1,021 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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