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Membrane Sweeping for Pregnancy
Phase 3
Waitlist Available
Led By Micah J Hill, D.O.
Research Sponsored by Tripler Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will help researchers understand if a common medical intervention to help induce labor is effective.
Who is the study for?
This trial is for pregnant individuals between 38 to 42 weeks of gestation with uncomplicated, singleton pregnancies who are candidates for vaginal delivery. It's not suitable for those under 38 weeks, dilated more than 3cm, with cervical infections, third trimester bleeding, multiple gestations, placenta previa or certain health conditions like diabetes and hypertension.Check my eligibility
What is being tested?
The study is testing the safety and effects of membrane sweeping in late-stage pregnancy to see if it increases the chances of membranes rupturing before labor starts. Membrane sweeping is a procedure used to potentially induce labor.See study design
What are the potential side effects?
Potential side effects may include discomfort during the procedure, spotting or bleeding afterwards, irregular contractions or cramps. There's also a focus on whether there's an increased risk of pre-labor rupture of membranes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
rates of prelabor rupture of membranes
Secondary outcome measures
Effects of membrane sweeping on indication for admission, inductions, reason for induction, estimated gestational age at delivery, cervical exam at admission, Bishop's score on admission, labor outcomes, route or delivery, pregnancy complications, neo
effects of patient age, gestational age, parity, race, cervical exam, post-graduate year level of physician or if the provider is a midwife or attending staff on rates of term PROM.
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Who is running the clinical trial?
Tripler Army Medical CenterLead Sponsor
20 Previous Clinical Trials
27,349 Total Patients Enrolled
Micah J Hill, D.O.Principal InvestigatorUnited States Army
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have an infection in my cervix.I have experienced bleeding in the last part of my pregnancy.I have diabetes that started before or during my pregnancy.I currently have an active genital herpes infection.I have long-term high blood pressure or had it during pregnancy.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
To whom does this experimental medication trial apply?
"Accepted patients for this clinical trial should have a rupture and be between 18-50 years old. Up to 300 total participants will be accepted."
Answered by AI
Are there any vacancies in this study for new participants?
"This specific trial is not looking for any more participants at this time, however that information was last updated in 2006. There are currently 180 other trials on clinicaltrials.gov that are actively recruiting people if you're interested."
Answered by AI
For this clinical research, are elderly patients being sought?
"This trial is open to people aged 18-50, as outlined in the inclusion criteria."
Answered by AI
What are the risks associated with this particular treatment plan?
"The safety of this treatment is estimated to be a 3. This assessment is based on the fact that this is a Phase 3 trial, which means that there is some evidence supporting the efficacy of the treatment as well as multiple rounds of data indicating that the treatment is safe."
Answered by AI
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