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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
MOCA Trial Summary
This trial studies if digital cervical exams can replace speculum exams in pregnant women with PPROM to help prevent preterm labor.
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.Check my eligibility
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.See study design
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.
MOCA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pregnancy latency
Secondary outcome measures
Composite neonatal morbidity
Endomyometritis
Hypoxic ischemic encephalopathy
+14 moreMOCA 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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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,609 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been stable for 8-72 hours after a rupture event.I am between 24 and 33 weeks pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Speculum Exams
- Group 2: Digital Exams
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings in the current trial for prospective participants?
"This clinical trial, first posted on March 27th 2023 and last updated 3 days later, is actively seeking participants as per the most recent data found on clinicaltrials.gov"
Answered by AI
How many participants are currently signed up for this medical experiment?
"Affirmative. According to clinicaltrials.gov, this research endeavor is currently recruiting participants for enrollment - the study was initially posted on March 27th 2023 and subsequently updated on March 30th 2023. 86 individuals need to be sourced from 1 site in order for the trial to begin."
Answered by AI
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