NCT05773014

Digital vs. Speculum Exams for PPROM

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• PPROM

Interventions

Type	Name	Description
PROCEDURE	Speculum Exams	Same as arm
PROCEDURE	Digital Exams	Same as arm

Timeline

• Start date: 2023-03-27
• Primary completion: 2027-03-01
• Completion: 2027-07-01
• First posted: 2023-03-17
• Last updated: 2026-01-05

Locations

1 site across 1 country: United States