Digital vs. Speculum Exams for PPROM
Digital Versus Speculum Exams in Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial
Washington University School of Medicine
86 participants
Mar 27, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria2
- Contraindications to digital examination
- COVID-19 positive on admission
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Same as arm
Same as arm
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05773014