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Passive Descent vs Pushing for Labor Management in Obese Women
N/A
Waitlist Available
Led By Alisse Hauspurg, MD
Research Sponsored by Women and Infants Hospital of Rhode Island
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Gestational age of 37 0/7 weeks and greater
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at delivery
Awards & highlights
Study Summary
This trial is investigating whether or not passive descent (allowing the baby to descend on its own without the mother pushing) could improve the spontaneous vaginal delivery rate in nulliparous, obese women.
Who is the study for?
This trial is for obese women with a BMI of 30 or higher who are pregnant for the first time, at least 37 weeks along, and have a single baby. They must be receiving regional anesthesia during labor. Women with lower BMIs, less than full-term pregnancies, fever before the second stage of labor, no regional anesthesia, previous deliveries after 20 weeks gestation, multiple babies in the womb or severe fetal anomalies cannot participate.Check my eligibility
What is being tested?
The study is testing two different methods to manage labor in obese women having their first child: 'Passive Descent' where they wait ninety minutes before pushing versus 'Immediate Pushing' when entering the second stage of labor. The goal is to see if passive descent increases spontaneous vaginal delivery rates.See study design
What are the potential side effects?
While not explicitly listed as side effects in this context since it's about management techniques rather than medication or surgery; potential risks may include fatigue from prolonged labor and possible complications from delayed active pushing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 37 weeks pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ participants will be followed for the duration of hospital stay, an expected average of 3 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will be followed for the duration of hospital stay, an expected average of 3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of spontaneous vaginal delivery
Secondary outcome measures
Neonatal Outcomes
Rate of Postpartum Hemorrhage
Rate of Third and Fourth Degree Lacerations
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Passive DescentExperimental Treatment1 Intervention
Patient's will wait 90 minutes prior to begin pushing
Group II: Immediate PushingActive Control1 Intervention
Patient's will begin to push when they are determined to be completely dilated.
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Who is running the clinical trial?
Women and Infants Hospital of Rhode IslandLead Sponsor
108 Previous Clinical Trials
38,000 Total Patients Enrolled
Alisse Hauspurg, MDPrincipal InvestigatorWomen & Infant's Hospital
2 Previous Clinical Trials
258 Total Patients Enrolled
Erika Werner, MDStudy DirectorWomen & Infant's Hospital
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had regional anesthesia.I will receive or have received regional anesthesia.I am at least 37 weeks pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate Pushing
- Group 2: Passive Descent
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.
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