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Digital vs. Speculum Exams for PPROM
Sponsor: Washington University School of Medicine
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
Speculum Exams
Same as arm
Digital Exams
Same as arm
Locations (1)
Barnes Jewish Hospital
St Louis, Missouri, United States