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RECRUITING
NCT05773014
NA

Digital vs. Speculum Exams for PPROM

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

Official title: Digital Versus Speculum Exams in Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2023-03-27

Completion Date

2027-07-01

Last Updated

2026-01-05

Healthy Volunteers

Yes

Conditions

Interventions

PROCEDURE

Speculum Exams

Same as arm

PROCEDURE

Digital Exams

Same as arm

Locations (1)

Barnes Jewish Hospital

St Louis, Missouri, United States