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Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial

NCT03504670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2021-04-27

No results posted yet for this 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.

Conditions

  • Preterm Pregnancy
  • Labor Induction

Interventions

PROCEDURE

Early Amniotomy

This intervention involves using an amniotomy hook to rupture the membranes during a sterile vaginal exam. This intervention will be performed prior to the cervix being dilated 4cm.

PROCEDURE

Late Amniotomy

This intervention involves using an amniotomy hook to rupture the membranes during a sterile vaginal exam. This intervention will be performed once the cervix is at least 4cm dilated.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Lindsay S Robbins, MD, MPH · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2020-08-26
Completion
2021-01-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03504670 on ClinicalTrials.gov