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Hormone Therapy
Oxytocin for Labor Complications (ROSSoL Trial)
N/A
Recruiting
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
Not on oxytocin at the time of complete cervical dilation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during admission for delivery
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether oxytocin can help during the second stage of labor.
Who is the study for?
This trial is for first-time pregnant women who are at least 37 weeks along, either going into labor on their own or being induced. It's not for those already fully dilated without oxytocin, have had children before, are expecting multiples, or whose babies have significant health issues.
What is being tested?
The study randomly assigns participants to either continue using oxytocin during the second stage of labor or stop it altogether. The goal is to see how stopping or continuing oxytocin affects labor complications.
What are the potential side effects?
Oxytocin may cause side effects like intense contractions leading to fetal distress, uterine rupture in rare cases, and postpartum hemorrhage due to uterine atony.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not on oxytocin when my cervix is fully dilated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during admission for delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during admission for delivery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Second stage duration
Secondary study objectives
Estimated blood loss
Rate of Postpartum hemorrhage
Chorioamnionitis
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Discontinue OxytocinExperimental Treatment1 Intervention
Group II: Continue OxytocinActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,343,862 Total Patients Enrolled
University of MichiganOTHER
1,863 Previous Clinical Trials
6,441,181 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on oxytocin when my cervix is fully dilated.Your baby's head is visible at the opening of the birth canal when the cervix is fully dilated.You are pregnant with one baby.You are pregnant and your baby has major health problems.You have given birth multiple times.You are pregnant with more than one baby.
Research Study Groups:
This trial has the following groups:- Group 1: Discontinue Oxytocin
- Group 2: Continue Oxytocin
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.