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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 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 86 participants.

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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.

Interventions

  • PROCEDURE Early Amniotomy
  • PROCEDURE Late Amniotomy

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2018-11-14
Est. Completion 2021-01-13
Phase NA

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT03504670

The ClinicalTrials.gov registry entry for NCT03504670 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Early Amniotomy is the first listed.

NCT03504670 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.