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RecruitingAccepts healthy volunteersMentions an overnight / inpatient stay

Digital vs. Speculum Exams for PPROM

Washington University School of Medicine · NCT05773014

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Any age listed · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
86
US sites recruiting
1
Study start
March 27, 2023
Record last updated
January 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Speculum Exams; Digital Exams

Conditions: PPROM

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Barnes Jewish Hospital

    St Louis, MO 63108

    Site contact: Nandini Raghuraman, MD · nraghuraman@wustl.edu

Study contacts (from the official record)

  • Nandini Raghuraman, MD · 3142732939 · nraghuraman@wustl.edu
  • Jaime Strickland · 3147471390 · jaime.strickland@wustl.edu
All pregnancy studies in Missouri →