Digital vs. Speculum Exams for PPROM

Recruiting now · Not applicable

Conditions studied: PPROM

In brief

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.

Key facts

Study ID

NCT05773014

Run by

Washington University School of Medicine

People needed

86

Starts

2023-03-27

Expected to finish

2027-07-01

Last updated by the study team

2026-01-05

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Contraindications to digital examination
• COVID-19 positive on admission

Where it is running

• Barnes Jewish Hospital — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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