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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
Must not have
unable to consent
admitted in the second stage of labor (>10cm) or beyond, with nonviable pregnancies (i.e. IUFD), score of 4 or more on a numeric pain rating scale, or desiring cesarean section will be excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of admission to delivery
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
Select...
I am admitted to LIJ or NSUH for labor.
Select...
My pain level is 3 or less on a scale of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to give consent by myself.
Select...
I am not in advanced labor, do not have a nonviable pregnancy, and my pain is manageable.
Select...
I am a woman under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of admission to delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of admission to delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fetal Position at time of delivery
Secondary study objectives
Laceration Type
Mode of delivery

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1260

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
474 Previous Clinical Trials
468,695 Total Patients Enrolled
Valerie Schulz, MDPrincipal InvestigatorNorthwell Health
Sarah Pachtman, MDPrincipal InvestigatorNorthwell Health

Media Library

Maternal Positioning Clinical Trial Eligibility Overview. Trial Name: NCT05307393 — N/A
Obstetric Complications Research Study Groups: C, A, B
Obstetric Complications Clinical Trial 2023: Maternal Positioning Highlights & Side Effects. Trial Name: NCT05307393 — N/A
Maternal Positioning 2023 Treatment Timeline for Medical Study. Trial Name: NCT05307393 — N/A
~0 spots leftby Jan 2025
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