RecruitingNot ApplicableNCT05773014

Digital vs. Speculum Exams for PPROM

Digital Versus Speculum Exams in Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial


Sponsor

Washington University School of Medicine

Enrollment

86 participants

Start Date

Mar 27, 2023

Study Type

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

Sex: FEMALE

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

PROCEDURESpeculum Exams

Same as arm

PROCEDUREDigital Exams

Same as arm


Locations(1)

Barnes Jewish Hospital

St Louis, Missouri, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05773014