RECRUITING

Digital vs. Speculum Exams for PPROM

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-27
Study Completion:2025-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05773014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 22 weeks 0 days gestation to 33 weeks 5 days gestation
  2. * Clinical or laboratory confirmation of PPROM
  3. * At least 8 hours after rupture event
  4. * English speaking
  1. * Contraindications to digital examination
  2. * COVID-19 positive on admission

Contacts and Locations

Study Contact

Julia Burd, MD
CONTACT
(314) 362-7135
burd.j@wustl.edu

Study Locations (Sites)

Barnes Jewish Hospital
Saint Louis, Missouri, 63108
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-27
Study Completion Date2025-01-01

Study Record Updates

Study Start Date2023-03-27
Study Completion Date2025-01-01

Terms related to this study

Keywords Provided by Researchers

  • PPROM
  • speculum exam
  • preterm birth
  • preterm prelabor rupture of membranes

Additional Relevant MeSH Terms

  • PPROM