Digital vs. Speculum Exams for Premature Rupture of Membranes

(MOCA Trial)

Overseen By Julia Burd, MD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Contraindications to digital exam, COVID-19

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

86 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Digital Exams, Speculum Exams for Premature Rupture of Membranes?

Research suggests that speculum examinations are adequate for assessing pregnant patients with spontaneous rupture of membranes, as they provide a reliable evaluation of the cervix. Additionally, digital examinations may impact maternal and neonatal outcomes, but the risk of infection is a concern, making speculum exams a safer option in some cases. ^{1 2 3 4 5}

Is it safe to have digital or speculum exams for premature rupture of membranes?

Research suggests that both digital and speculum exams are generally safe for assessing premature rupture of membranes, but the choice between them may affect clinical outcomes. Some studies indicate that digital exams might influence the latency period (time until labor starts) and maternal and neonatal outcomes, so it's important to discuss with your healthcare provider which method is best for your situation. ^{1 2 4 5 6}

How do digital and speculum exams differ as treatments for premature rupture of membranes?

Digital exams involve using fingers to assess the cervix, while speculum exams use a tool to visually inspect the area. The choice between them can affect the risk of infection and the accuracy of diagnosing membrane rupture. ^{1 2 3 4 5}

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Inpatient Monitoring

Patients are admitted for close monitoring of complications such as preterm labor, intraamniotic infection, and placental abruption

Up to 10 weeks

Continuous inpatient monitoring

Cervical Evaluation

Cervical evaluation using either sterile speculum or digital exams to assess cervical dilation, effacement, and station

As clinically indicated

Follow-up

Participants are monitored for safety and effectiveness after delivery, including assessments for maternal and neonatal outcomes

Up to 1 year

Treatment Details

Interventions

• Digital Exams
• Speculum Exams

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of digital vaginal examinations on latency period in preterm premature rupture of membranes. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

Is there a need for digital examination in patients with spontaneous rupture of the membranes? [2019]

3. England pubmed.ncbi.nlm.nih.gov

Infectious morbidity of speculum versus digital examinations in preterm prelabor rupture of membranes: a systematic review and meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Is a speculum examination sufficient for excluding the diagnosis of ruptured fetal membranes? [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The impact of digital cervical examination on expectantly managed preterm rupture of membranes. [2007]

6. England pubmed.ncbi.nlm.nih.gov

Prospective cohort study investigating the reliability of the AmnioSense method for detection of spontaneous rupture of membranes. [2008]