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Prophylactic Manual Rotation for Labor Complications (PROMISE Trial)
N/A
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Complete cervical dilation
Have neuraxial anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until delivery, up to 300 minutes
Awards & highlights
PROMISE Trial Summary
This trial will compare outcomes of two different methods for dealing with a baby in a difficult birth position.
Who is the study for?
This trial is for first-time mothers who are at least 18 years old, speak English, and are planning a vaginal birth at term (37+ weeks). They must have an epidural in place, ruptured membranes, full cervical dilation, and a baby presenting head down but facing upwards or sideways. Excluded are those with certain fetal heart rate concerns or other factors that could complicate vaginal delivery.Check my eligibility
What is being tested?
The study tests if manually turning the baby to a better position during early second stage of labor can reduce the need for operative delivery (like forceps or cesarean) and shorten labor. Participants will be randomly assigned to either receive this manual rotation or a pretend 'sham' rotation as part of standard care.See study design
What are the potential side effects?
While not drug-related, potential side effects may include discomfort from the manual rotation procedure itself. There's also a risk that trying to turn the baby might lead to complications requiring an operative delivery.
PROMISE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cervix has fully dilated.
Select...
I have had spinal or epidural anesthesia.
Select...
I am 18 years old or older.
PROMISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from delivery until hospital discharge, up to 28 days of life
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from delivery until hospital discharge, up to 28 days of life
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants in each group who undergo operative delivery
Secondary outcome measures
Number of days a participant in each group has a neonate requiring neonatal intensive care unit (NICU) admission
Number of minutes in the second stage of labor in each group
Number of participants in each group affected by neonatal intensive care unit (NICU) admission
+15 morePROMISE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Prophylactic manual rotationExperimental Treatment1 Intervention
Prophylactic manual rotation involves a vaginal examination performed with an obstetric provider's hands to turn the baby from a position in which the baby's face is looking up in the direction of the ceiling (occiput posterior) or to the side (occiput transverse) to a position in which the baby's face is looking down in the direction of the mother's spine (occiput anterior). Prophylactic manual rotation will occur at the initiation of pushing once the individual achieves complete cervical dilation.
Group II: Sham rotationPlacebo Group1 Intervention
Sham rotation involves a vaginal exam that obstetric providers commonly do with their hands to assess cervical dilation and fetal position during routine labor, and will occur at the initiation of pushing once the individual achieves complete cervical dilation.
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,586 Previous Clinical Trials
916,939 Total Patients Enrolled
Stephanie Fisher, MD MPHStudy DirectorNorthwestern University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cervix has fully dilated.I have had spinal or epidural anesthesia.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Prophylactic manual rotation
- Group 2: Sham rotation
Awards:
This trial has 0 awards, including: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 there any opportunities to join this medical study at the present time?
"According to the records on clinicaltrials.gov, this medical study is currently calling for volunteers - it was initially published on March 4th 2022 and has been revised as recently as April 2nd 2022."
Answered by AI
How many individuals have been accepted into this research project?
"Yes, according to clinicaltrials.gov this trail is actively recruiting participants as it was first posted on March 4th 2022 and most recently updated April 2nd 2022. The trial aims to enroll 350 patients at a single site."
Answered by AI
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