50 Micrograms Vaginal Misoprostol (Intervention) for Prolonged Labor

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Texas at Austin Dell Medical School, Department of Women's Health, Austin, TXProlonged Labor+2 More50 Micrograms Vaginal Misoprostol (Intervention) - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing whether a higher dose of the drug misoprostol may help reduce the time from induction to delivery in obese women.

Eligible Conditions
  • Prolonged Labor
  • Obesity
  • Pregnancy

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Similar Trials

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intravenous oxytocin
1
Water Birth
1
Experimental: oxytocin 0.3 micrograms then oxytocin 7 micrograms

Study Objectives

1 Primary · 24 Secondary · Reporting Duration: Assessed following delivery, through study completion which is estimated at 1 year.

Hour 4
Number of Participants exhibiting Uterine Tachysystole
Number of Participants exhibiting Uterine Tachysystole with Fetal Decelerations
Assessed at time of delivery
Indication for Cesarean Delivery (if applicable)
Number of Participants diagnosed with Postpartum hemorrhage
Day 30
Composite Neonatal Morbidity (ICU admission, APGAR <=7 at 5 minutes, Sepsis, Acidemia identified upon cord collection (pH < 7.15, Base Deficit >12.0 mmol), Induced Hypothermia, Perinatal Death)
Year 1
Number of Cesarean Deliveries
Number of Operative Deliveries
Number of Vaginal Deliveries
Day 5
Patient Satisfaction (Labor Pain Scale, Question 1)
Patient Satisfaction (Labor Pain Scale, Question 2)
Patient Satisfaction (Labor Pain Scale, Question 3)
Patient Satisfaction (Labor Pain Scale, Question 4)
Patient Satisfaction Six Simple Questions, Question 1
Patient Satisfaction Six Simple Questions, Question 2
Patient Satisfaction Six Simple Questions, Question 3
Patient Satisfaction Six Simple Questions, Question 4
Patient Satisfaction Six Simple Questions, Question 5
Patient Satisfaction Six Simple Questions, Question 6
Day 3
Interval time from labor induction to vaginal delivery
Day 5
Composite Maternal Morbidity (ICU admission, Sepsis, Need for Transfusion, Death)
Day 3
Interval time from labor induction initiation to complete cervical dilation
From baseline to the time of delivery
Number of Participants diagnosed with Clinical Chorioamnionitis
Number of Participants exhibiting Non-Reassuring Fetal Heart Tracings
Number of Participants receiving Terbutaline
Day 3
Interval time from labor induction initiation to delivery (vaginal or cesarean)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
intravenous oxytocin
1
Water Birth
2
Experimental: oxytocin 0.3 micrograms then oxytocin 7 micrograms

Trial Design

2 Treatment Groups

25 Micrograms Vaginal Misoprostol (Control)
1 of 2
50 Micrograms Vaginal Misoprostol (Intervention)
1 of 2

Active Control

Experimental Treatment

180 Total Participants · 2 Treatment Groups

Primary Treatment: 50 Micrograms Vaginal Misoprostol (Intervention) · No Placebo Group · Phase 4

50 Micrograms Vaginal Misoprostol (Intervention)
Drug
Experimental Group · 1 Intervention: 50 Micrograms Vaginal Misoprostol (Intervention) · Intervention Types: Drug
25 Micrograms Vaginal Misoprostol (Control)
Drug
ActiveComparator Group · 1 Intervention: 25 Micrograms Vaginal Misoprostol (Control) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed following delivery, through study completion which is estimated at 1 year.

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
297 Previous Clinical Trials
67,758 Total Patients Enrolled
Lorie Harper, MD, MSCIStudy DirectorDivision Chief, Maternal-Fetal Medicine

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are pregnant with one baby.
You have a body mass index (BMI) of 30 or higher at the time of labor induction.
The baby's head is positioned downwards in the birth canal, or has been turned into this position successfully.
You plan to use a method to soften and open the cervix for childbirth.
References

Frequently Asked Questions

Is enrollment for this experiment ongoing at the present time?

"The research team is actively recruiting participants for this trial, first posted on June 1st 2022 and most recently updated on the 2nd." - Anonymous Online Contributor

Unverified Answer

To what extent could 50 Micrograms Vaginal Misoprostol (Intervention) be detrimental to individuals?

"Our assessment at Power yielded a score of 3 for the safety of 50 Micrograms Vaginal Misoprostol, as this interventional treatment has already been approved and is in its fourth phase." - Anonymous Online Contributor

Unverified Answer

What is the aggregate population that has enrolled in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical examination is presently enrolling individuals who meet the criteria set forth by the team of researchers; it was initially posted on June 1st 2022 and its details were last updated on June 2nd 2022. The trial aims to recruit 180 participants from a single research facility." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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