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Delivery Positioning for Childbirth Trauma Protection (4P Trial)
N/A
Waitlist Available
Led By William H Barth, MD
Research Sponsored by Massachusetts General Hospital
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 at the time of vaginal delivery
Awards & highlights
4P Trial Summary
This trial will compare the effects of two different techniques for delivering the baby's head during vaginal birth.
Who is the study for?
This trial is for first-time mothers with a single, non-anomalous baby in the correct head-down position at full term who are planning to give birth vaginally. Women who've given birth before, have had genital surgeries or malformations, multiple babies at once, or any fetal conditions that make labor risky can't join.Check my eligibility
What is being tested?
The study is looking into whether hip extension during childbirth (as opposed to the common practice of hip flexion) reduces severe perineal tears when the baby's head appears. It compares this new method against the standard care given during delivery.See study design
What are the potential side effects?
Since this trial involves birthing positions rather than medications, side effects may include discomfort from positioning and potential differences in perineal trauma outcomes compared to usual birthing practices.
4P Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of vaginal delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of vaginal delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Classification of perineal laceration
Secondary outcome measures
Rate of OASIS laceration
4P Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hip extensionExperimental Treatment1 Intervention
Patients in this arm will be randomized to hip extension at the time of crowning of the fetal vertex during vaginal delivery.
Group II: Usual careActive Control1 Intervention
Patients in this arm will be randomized to the routine positioning instructions given at the time of crowning of the fetal vertex during vaginal delivery.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,197,149 Total Patients Enrolled
William H Barth, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
2,223 Total Patients Enrolled
Marti D Soffer, MD MPHPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The baby is in the head-down position for birth.You have undergone female genital mutilation in the past.The baby has reached full term and is ready to be born.I have had surgery in the area between my genitals and anus.If you are pregnant and in labor, the study cannot be conducted.My unborn baby does not have any genetic abnormalities.Women who have never given birth.I have given birth more than once.You are able to have a trial of labor for childbirth.You have had previous abnormalities in the area between your anus and genitals.You are pregnant with more than one baby (twins, triplets, etc.).Pregnant individuals carrying fetuses with abnormalities.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care
- Group 2: Hip extension
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 geriatric individuals being included in this clinical trial?
"This clinical trial is only available to those aged 18-55. However, there are 6 trials suited for minors and 11 studies catered towards seniors over 65 years old."
Answered by AI
Is eligibility for this experiment open to me?
"The study is seeking 1206 participants with perineal lacerations aged between 18 and 55. Eligibility criteria include: never having given birth, a normal fetus, term gestation, and vertex presentation."
Answered by AI
Are there still opportunities for members of the public to join this clinical endeavor?
"According to clinicaltrials.gov, this particular trial is not enrolling participants at the moment. The study was initially announced on April 5th 2021 and last modified March 18th 2022; nevertheless, 17 other trials are actively seeking patients."
Answered by AI
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