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Maternal Positioning for Fetal Occiput Posterior Position
N/A
Waitlist Available
Led By Valerie Schulz, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
admitted to LIJ or NSUH for either spontaneous labor or labor induction.
All patients must be <10cm, with a score of 3 or less out of 10 on a numeric pain rating scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of admission to delivery
Awards & highlights
Study Summary
This trial is testing whether or not a mother's position during labor affects the position of the baby.
Who is the study for?
This trial is for women over 18 years old, at full term (37+ weeks pregnant) with a single baby in head-down position facing up ('sunny side up') when admitted for labor. They must be less than 10cm dilated and have mild pain (score of ≤3/10). Excluded are those under 18, unable to consent, in advanced labor (>10cm), wanting cesarean delivery or with complications like fetal growth restriction or abnormal presentations.Check my eligibility
What is being tested?
The study tests if certain maternal positions during the first stage of labor can turn babies from a 'sunny side up' position to a more favorable one for vaginal birth. Women will be randomly placed into three groups: control group choosing any position, and two experimental groups using specific positioning strategies based on fetal movement.See study design
What are the potential side effects?
There may not be direct side effects from participating; however, discomfort from maintaining certain positions is possible. Also, there's always a risk that the intervention might not lead to the desired baby positioning.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am admitted to LIJ or NSUH for labor.
Select...
My pain level is 3 or less on a scale of 10.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of admission to delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of admission to delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fetal Position at time of delivery
Secondary outcome measures
Laceration Type
Mode of delivery
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: CExperimental Treatment1 Intervention
Group C, will be placed in the same position but opposite that of which fetal kicks are felt.
Group II: BExperimental Treatment1 Intervention
Group B will be placed in a dorsal recumbent, modified sims position on the side of fetal movement.
Group III: AActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positioning
2023
N/A
~1190
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,468 Total Patients Enrolled
Valerie Schulz, MDPrincipal InvestigatorNorthwell Health
Sarah Pachtman, MDPrincipal InvestigatorNorthwell Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to give consent by myself.I am admitted to LIJ or NSUH for labor.I am not in advanced labor, do not have a nonviable pregnancy, and my pain is manageable.I am a woman aged 18 or older.I am a woman under 18 years old.My pain level is 3 or less on a scale of 10.
Research Study Groups:
This trial has the following groups:- Group 1: C
- Group 2: A
- Group 3: B
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.
Is it possible to sign up for this research project at this time?
"Unfortunately, this study is not enrolling patients at the moment according to its clinicaltrials.gov listing. This research was originally posted on January 1st 2023 but was last updated over half a year ago on August 15th, 2022. However, there are two other trials that are recruiting patients right now."
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