Digital vs. Speculum Exams for PPROM

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05773014
Status
Recruiting
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Conditions

  • PPROM

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Speculum Exams — PROCEDURE
    Same as arm
  • Digital Exams — PROCEDURE
    Same as arm

Study Details

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 Dates

Start date
Mar 27, 2023
Status verified
Dec 2025
Primary completion
Mar 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Speculum Exams
    If a patient requires cervical evaluation after PPROM, their cervix will be evaluated with a sterile speculum exam. A sterile speculum with lubricating jelly will be inserted into the patient's vagina to visualize the cervix and visually estimate cervical dilation and effacement.
  • Active Comparator: Digital Exams
    If a patient requires cervical evaluation after PPROM, their cervix will be evaluated with a digital exam. The provider will wear sterile gloves with lubricating jelly and will palpate the cervix to assess cervical dilation, effacement, and station.

Primary Outcome Measure

Pregnancy latency [ Time Frame: up to 10 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Barnes Jewish HospitalSt LouisMissouri63108
Nandini Raghuraman, MD
[email protected]

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By research site
Barnes Jewish Hospital· St Louis, MO