50 Micrograms Vaginal Misoprostol (Intervention) for Prolonged Labor
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.
- Prolonged Labor
- Obesity
- Pregnancy
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 24 Secondary · Reporting Duration: Assessed following delivery, through study completion which is estimated at 1 year.
Trial Safety
Safety Progress
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Female Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Hamilton, Brady E., and Stephanie J. Ventura. 2006. “Fertility and Abortion Rates in the United States, 1960-2002”. International Journal of Andrology. Wiley. doi:10.1111/j.1365-2605.2005.00638.x.
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- Adhikari, Emily H., David B. Nelson, Donald D. McIntire, and Kenneth J. Leveno. 2020. “Foley Bulb Added to an Oral Misoprostol Induction Protocol”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000004123.
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- Wolfe, Katherine B., Rocco A. Rossi, and Carri R. Warshak. 2011. “The Effect of Maternal Obesity on the Rate of Failed Induction of Labor”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2011.03.051.
- Knutson, Karin Britta MD; Leung, Katherine MPH; Allocco, Elizabeth Rose MD; Minor, Kathleen MD; Delpapa, Ellen MD; Lauring, Julianne MD Time to Delivery Following Induction of Labor in Obese Versus Normal-Weight Women [11S], Obstetrics & Gynecology: May 2019 - Volume 133 - Issue - p 205S
- Staudenmaier, Emily K. DO; Chatterton, Carolyn G. DO, MPH; Montanez, Marelli DO; Sampino, Isabella; Vullo, John J. DO; Gurram, Padmalatha MD, MSCTR Induction of Labor Compared With Expectant Management and Risk of Cesarean Delivery in Obese Women [7F], Obstetrics & Gynecology: May 2019 - Volume 133 - Issue - p 63S-64S
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- Pevzner, Leo, Barbara L. Powers, William F. Rayburn, Pamela Rumney, and Deborah A. Wing. 2009. “Effects of Maternal Obesity on Duration and Outcomes of Prostaglandin Cervical Ripening and Labor Induction”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0b013e3181bfb39f.
- Carbone, Jeanine F., Methodius G. Tuuli, Patricia J. Fogertey, Kimberly A. Roehl, and George A. Macones. 2013. “Combination of Foley Bulb and Vaginal Misoprostol Compared with Vaginal Misoprostol Alone for Cervical Ripening and Labor Induction”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0b013e31827e5dca.
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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
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
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