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NCT05773014NARecruitingAccepts Healthy Volunteers

Digital vs. Speculum Exams for PPROM

Washington University School of Medicine

Start Date

3/27/2023

Completion Date

7/1/2027

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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * 22 weeks 0 days gestation to 33 weeks 5 days gestation * Clinical or laboratory confirmation of PPROM * At least 8 hours after rupture event * English speaking Notably, for patients \<25 weeks, approach for enrollment will be deferred until after the patient has discussed their desires for fetal resuscitation with the care team and are at a gestational age where they would desire this resuscitation. Exclusion Criteria: * Contraindications to digital examination * COVID-19 positive on admission

Interventions

PROCEDURE

Speculum Exams

PROCEDURE

Digital Exams

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Conditions

PPROM

Locations

Barnes Jewish Hospital

St Louis, Missouri 63108

United States