Digital vs. Speculum Exams for PPROM — MOCA  

PPROM Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• PPROM

• NCT number: NCT05773014
• Study type: Interventional
• Source: Washington University School of Medicine
• Contact: Julia Burd, MD
• Phone: (314) 362-7135
• Email: burd.j@wustl.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Completion date: January 1, 2025