Actively Recruiting
Digital vs. Speculum Exams for PPROM
Led by Washington University School of Medicine · Updated on 2026-01-05
86
Participants Needed
1
Research Sites
222 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Digital vs. Speculum Exams for PPROM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 22 weeks 0 days and 33 weeks 5 days of pregnancy
- Clinical or laboratory confirmation of preterm prelabor rupture of membranes (PPROM)
- At least 8 hours have passed since the rupture event
- Able to speak and understand English
- For pregnancies under 25 weeks, patient has discussed fetal resuscitation desires with care team and is at a gestational age where resuscitation is desired
You will not qualify if you...
- Any medical reason that prevents safe digital examination
- Testing positive for COVID-19 upon admission
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Barnes Jewish Hospital
St Louis, Missouri, United States, 63108
Actively Recruiting
Research Team
N
Nandini Raghuraman, MD
CONTACT
J
Jaime Strickland
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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