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Routine Early vs Delayed Amniotomy for Preterm Pregnancies: A Randomized Open Label Trial

NCT03682822 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2021-05-05

No results posted yet for this study

Summary

To compare the duration of preterm induction of labor in women undergoing early vs. late or no artificial rupture of membranes (AROM). Maternal and neonatal outcomes will also be compared between the two groups.

Conditions

  • Labor, Premature

Interventions

PROCEDURE

Early Artificial rupture of membranes

Women in this arm will undergo artificial rupture of membranes before 4 cm of cervical dilation is reached during induction of labor as long as the procedure is deemed clinically safe and feasible.

PROCEDURE

Delayed Artificial rupture of membranes

Women in this arm may undergo artificial rupture of membranes performed only after 4 cm of cervical dilation is reached during induction of labor. Rupture may also be performed after 10 hours of oxytocin administration with no cervical change.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Clifton O Brock, MD · University of Texas Health Science Center of Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-02-22
Completion
2020-02-24

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 NCT03682822 on ClinicalTrials.gov