What side effects are associated with this type of intervention?

In the context of Premature Rupture of Membranes (PPROM), sterile digital exams and sterile speculum exams are commonly used methods for evaluating cervical dilation. Sterile digital exams have been associated with a potential decrease in pregnancy latency, which means they might lead to earlier delivery. This could increase the risk of complications related to preterm birth. Sterile speculum exams, while traditionally preferred to avoid this risk, can still cause discomfort and may introduce a risk of infection if not performed under strict sterile conditions. Both methods require careful handling to minimize adverse outcomes.

What prior FDA approvals exist?

There are no specific FDA-approved treatments solely for Premature Rupture of Membranes (PROM). Management typically involves hospitalization and close monitoring for complications such as preterm labor and infections. Treatments focus on prolonging pregnancy and preventing infections, often using antibiotics and corticosteroids to enhance fetal lung maturity. The trial comparing sterile digital exams to speculum exams for cervical evaluation in PROM patients is part of ongoing research to optimize management strategies.

What other types of research exist?

A promising alternative to sterile digital exams for cervical examination in PPROM patients is the sterile speculum exam. This method is traditionally used due to concerns about reducing pregnancy latency with digital exams. The randomized, non-inferiority trial suggests that speculum exams are a viable alternative. No other novel methods are explicitly mentioned in the provided context.

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Digital vs. Speculum Exams for Premature Rupture of Membranes (MOCA Trial)

N/A

Recruiting

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed, but concerns may include increased risk of infection or preterm labor due to the examination method used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pregnancy latency

Secondary study objectives

Composite neonatal morbidity

Endomyometritis

Hypoxic ischemic encephalopathy

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Speculum ExamsActive Control1 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 ExamsActive Control1 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Premature Rupture of Membranes (PROM) treatments primarily aim to monitor and prevent complications such as infection and preterm labor. Sterile speculum exams are commonly used to assess cervical dilation while minimizing infection risk. The trial comparing sterile digital exams to speculum exams seeks to determine if the method of examination affects the latency period between membrane rupture and delivery. This is important as it helps ensure accurate labor assessment while reducing infection risks, crucial for the health of both mother and baby.

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