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Digital vs. Speculum Exams for PPROM
Digital Versus Speculum Exams in Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial
Who can join
All ages · Women · Healthy volunteers welcome
Full eligibility criteria
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
About the study
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.
What is being tested
- Speculum Exams (procedure)
- Digital Exams (procedure)
Sponsor: Washington University School of Medicine · Participants: 86 · Started: Mar 27, 2023
Contact the study team
- Nandini Raghuraman, MD · Phone: 3142732939
- Jaime Strickland · Phone: 3147471390
Official record on ClinicalTrials.gov — NCT05773014
Locations in the U.S.
| Missouri | Barnes Jewish Hospital, St Louis |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.