Digital vs. Speculum Exams for PPROM (MOCA)

The Washington University

Status: Enrolling

Conditions: PPROM

Treatments: Procedure: Speculum Exams; Procedure: Digital Exams

Study type: Interventional

Funder types: Other

Identifiers

NCT05773014

202301012

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Exclusion criteria

• Contraindications to digital examination
• COVID-19 positive on admission

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Speculum Exams

Active Comparator group

Description:

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.

Treatment:

Procedure: Speculum Exams

Digital Exams

Active Comparator group

Description:

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.

Treatment:

Procedure: Digital Exams