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Digital vs. Speculum Exams for PPROM

NCT05773014 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-01-05

No results posted yet for this study

Summary

After preterm prelabor rupture of membranes (PPROM)\[breaking of the amniotic sac prior to 37 weeks gestation in pregnancy\], patients are recommended for inpatient admission and close monitoring for complications including preterm labor, intraamniotic infection (infection of the sac around the baby), and placental abruption (separation of the placenta from wall of the uterus). When evaluation of cervical dilation is clinically indicated, obstetricians traditionally perform sterile speculum exams due to concern for decrease in pregnancy latency (length of time between breaking the water and delivery) with sterile digital exams in retrospective studies. These studies are concerning, however, by the indications for the exams and are at risk for confounding by indication. This is a randomized, non-inferiority trial to examine if sterile digital versus speculum exams effect latency of pregnancy in patients with PPROM.

Conditions

  • PPROM

Interventions

PROCEDURE

Speculum Exams

Same as arm

PROCEDURE

Digital Exams

Same as arm

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-27
Primary Completion
2027-03-01
Completion
2027-07-01

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 NCT05773014 on ClinicalTrials.gov