Digital vs. Speculum Exams for Premature Rupture of Membranes

(MOCA Trial)

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is comparing two methods for checking how much the cervix has opened in pregnant women whose water broke early. One method uses a gloved finger, and the other uses a tool called a speculum. The goal is to see if both methods are equally safe and effective without causing more problems.

Research Team

Eligibility Criteria

This trial is for pregnant individuals between 24 weeks and 33 weeks +5 days gestation who have experienced PPROM (their water broke early) and have been stable for 8-72 hours post-rupture. Participants must speak English and be confirmed to have PPROM clinically or via lab tests.

Inclusion Criteria

English speaking

I have been stable for 8-72 hours after a rupture event.

Clinical or laboratory confirmation of PPROM

Treatment Details

Interventions

• Digital Exams (Procedure)
• Speculum Exams (Procedure)

Trial Overview The study compares two methods of checking cervical dilation in patients with PPROM: sterile digital exams (using fingers) versus speculum exams (using an instrument). It aims to see if one method leads to longer pregnancy after the water breaks, without increasing risks.

Participant Groups

Group I: Speculum Exams Active Control 1 Intervention

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 II: Digital Exams Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine