Digital vs. Speculum Exams for Premature Rupture of Membranes
(MOCA Trial)
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.12345Why 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.12567
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Inpatient Monitoring
Patients are admitted for close monitoring of complications such as preterm labor, intraamniotic infection, and placental abruption
Cervical Evaluation
Cervical evaluation using either sterile speculum or digital exams to assess cervical dilation, effacement, and station
Follow-up
Participants are monitored for safety and effectiveness after delivery, including assessments for maternal and neonatal outcomes
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?
2
Treatment groups
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Citations
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 ...
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, ...
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 ...
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 ...
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researchgate.net
researchgate.net/publication/12289752_The_impact_of_digital_cervical_examination_on_expectantly_managed_preterm_rupture_of_membranesThe 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 ...
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 ...
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.
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