Digital vs. Speculum Exams for PPROM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-27

Study Completion Date

2027-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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PPROM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Speculum Exams

Intervention Type PROCEDURE

Same as arm

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.

Group Type ACTIVE_COMPARATOR

Digital Exams

Intervention Type PROCEDURE

Same as arm

Interventions

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Speculum Exams

Same as arm

Intervention Type PROCEDURE

Digital Exams

Same as arm

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.