Digital vs. Speculum Exams for Premature Rupture of Membranes

(MOCA Trial)

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether digital exams are as effective as speculum exams for checking cervical dilation in pregnant women with PPROM (when the water breaks before 37 weeks). Researchers are comparing both methods to assess their impact on the duration of pregnancy after the water breaks. Women between 22 and 33 weeks pregnant with confirmed PPROM may qualify to participate. The goal is to ensure safe and effective care for mothers and their babies during this critical time. As an unphased trial, this study allows participants to contribute to important research that could enhance prenatal care practices.

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 prior data suggests that these examination methods are safe for evaluating cervical dilation in PPROM patients?

Studies have shown that both digital and speculum exams are generally safe for assessing cervical dilation in patients with preterm prelabor rupture of membranes (PPROM). However, research suggests that multiple digital exams might slightly increase the risk of infection. Specifically, one study found that more than eight digital exams increased the risk of infection compared to one to three exams.

In contrast, speculum exams are considered safer for checking the cervix when membranes have ruptured early. Experts state that speculum exams allow for a careful examination of the cervix without increasing the risk of infection.

Both methods have been used in medical settings for a long time and are generally well-tolerated. Prospective trial participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different methods for evaluating cervical changes after a premature rupture of membranes (PPROM). Traditionally, speculum exams are the norm, allowing doctors to visually assess the cervix. This trial also considers digital exams, where doctors use their hands to feel the cervix's dilation and effacement. The potential for digital exams to be less invasive while still providing accurate assessments could transform patient comfort and care. This trial could reveal whether one method offers better outcomes, helping to tailor a more efficient and patient-friendly approach in such cases.

What evidence suggests that this trial's exams could be effective for evaluating cervical dilation in patients with PPROM?

Research has shown that frequent digital exams can increase the risk of complications, such as chorioamnionitis, an infection of the fetal membranes. However, the impact of these exams on pregnancy outcomes remains unclear, though some studies suggest they might lead to earlier labor. Professional guidelines generally recommend speculum exams to check the cervix if preterm premature rupture of membranes (PPROM) occurs, as they are often considered less likely to trigger early labor compared to digital exams. This trial will compare digital exams with speculum exams to determine if digital exams are as safe and effective as speculum exams for PPROM. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11035354/

The impact of digital cervical examination on ... - PubMed Objective: The purpose of this study was to examine the effects of digital cervical examination on maternal and neonatal outcomes among women with preterm ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933321002202

Incremental risk of clinical chorioamnionitis associated with ... Individuals with ≥8 cervical exams had 1.7 times the risk of developing clinical chorioamnionitis compared with those with 1 to 3 exams. Prolonged rupture time, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39374906/

Perinatal Outcomes Based on Number of Digital Exams in ... There was an increase in spontaneous labor in the group with more digital exams; this may be due to confounding by indication, as patients who ...

4. emedicine.medscape.com emedicine.medscape.com/article/261137-overview

Overview, Premature Rupture of Membranes (at Term) ... PPROM is associated with 30-40% of preterm deliveries and is the leading identifiable cause of preterm delivery. PPROM complicates 2-3% of all ...

5. researchgate.net researchgate.net/publication/12289752_The_impact_of_digital_cervical_examination_on_expectantly_managed_preterm_rupture_of_membranes

The impact of digital cervical examination on expectantly ... The purpose of this study was to examine the effects of digital cervical examination on maternal and neonatal outcomes among women with ...

6. aafp.org aafp.org/pubs/afp/issues/2006/0215/p659.html

Preterm Premature Rupture of Membranes: Diagnosis and ... Physicians should not perform digital cervical examinations on patients with preterm PROM because they decrease the latent period. Speculum ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK532888/

Preterm and Term Prelabor Rupture of Membranes (PPROM ... After PROM at term, outcomes are generally favorable. Birth within 7 days of membrane rupture occurs in at least 50% of patients with PPROM.