Misoprostol Dosing in BMI Greater Than 30

NCT05262738 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY00002350
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are performing a randomized controlled-trial investigating if 50mcg (compared to 25 mcg) of vaginal misoprostol reduces the time from induction start to delivery in obese women.

Conditions

Pregnancy Related; Obesity; Labor Onset and Length Abnormalities

Keywords

Induction of Labor; Cervical Ripening; Misoprostol; Obesity

Outcome Measures

Primary Outcomes (1)

• Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean)

  From baseline to the time of delivery (baseline is initiation of labor induction), up to 3 days

Secondary Outcomes (17)

• Interval Time From Labor Induction to Vaginal Delivery

  From baseline (baseline is initiation of labor induction) to the time of vaginal delivery, up to 3 days

• Number of Cesarean Deliveries

  Assessed following delivery, through study completion which is estimated at 1 year.

• Number of Participants Exhibiting Uterine Tachysystole

  Assessed 4 hours post-misoprostol placement

• Number of Participants Exhibiting Uterine Tachysystole With Fetal Decelerations

  Assessed 4 hours post-misoprostol placement

• Number of Participants Receiving Terbutaline

  From baseline to the time of delivery

Study Arms (2)

50 Micrograms Vaginal Misoprostol (Intervention)

EXPERIMENTAL

Subjects in this arm will be randomized to the 50 micrograms of vaginal misoprostol (intervention) group, they will be admitted to labor and delivery and undergo placement of 50 micrograms of intravaginal misoprostol every 4 hours for cervical ripening.

Drug: 50 Micrograms Vaginal Misoprostol (Intervention)

25 Micrograms Vaginal Misoprostol (Control)

ACTIVE COMPARATOR

Subjects in this arm will be randomized to the 25 micrograms of vaginal misoprostol (control) group, they will be admitted to labor and delivery and undergo placement of 25 micrograms of intravaginal misoprostol every 4 hours for cervical ripening.

Drug: 25 Micrograms Vaginal Misoprostol (Control)

Interventions

50 Micrograms Vaginal Misoprostol (Intervention) DRUG

Subjects will undergo cervical ripening with 50 micrograms of vaginal misoprostol every 4 hours.

Also known as: Cytotec

50 Micrograms Vaginal Misoprostol (Intervention)

25 Micrograms Vaginal Misoprostol (Control) DRUG

Subjects will undergo cervical ripening with 25 micrograms of vaginal misoprostol every 4 hours.

Also known as: Cytotec

25 Micrograms Vaginal Misoprostol (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton gestation
• Age 18 years or older
• Gestational age \>= 36 weeks
• BMI \>= 30 kg/m2 at time of labor induction
• Cephalic presentation (including successful external cephalic version)
• Cervical dilation \<= 3cm
• Intent to proceed with cervical ripening

You may not qualify if:

• Contraindication to vaginal delivery (placenta previa, vasa previa, prior classical cesarean, non-vertex presentation, etc.)
• Contraindication to prostaglandin administration (significant allergy, prior cesarean delivery, etc.)
• Multiple gestations
• Gestational age \< 36 weeks
• Non-reassuring fetal heart tracing
• Evidence of clinical chorioamnionitis
• Significant vaginal bleeding with concern for abruption
• Prior cesarean delivery or uterine surgery
• Major fetal anomaly or demise
• Cervix \>3cm
• No intention to proceed with cervical ripening (not indicated, favorable bishop score, plan for Oxytocin administration, etc.)
• Uterine tachysystole (defined as \>= 5 contractions within a 10m period)
• Fetal Growth Restriction (EFW \<= 5% or elevated/absent/reversed Umbilical Artery dopplers)
• Inability to give consent (inability to read/write in English or Spanish)

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin Dell Medical School, Department of Women's Health

Austin, Texas, 78705, United States

Location

Related Publications (26)

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  PMID: 33752219 BACKGROUND

• Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.

  PMID: 23303106 BACKGROUND

• Viteri OA, Tabsh KK, Alrais MA, Salazar XC, Lopez JM, Fok RY, Chauhan SP, Sibai BM. Transcervical Foley Balloon Plus Vaginal Misoprostol versus Vaginal Misoprostol Alone for Cervical Ripening in Nulliparous Obese Women: A Multicenter, Randomized, Comparative-Effectiveness Trial. Am J Perinatol. 2021 Aug;38(S 01):e123-e128. doi: 10.1055/s-0040-1708805. Epub 2020 Apr 16.

  PMID: 32299108 BACKGROUND

• Al-Ibraheemi Z, Brustman L, Bimson BE, Porat N, Rosenn B. Misoprostol With Foley Bulb Compared With Misoprostol Alone for Cervical Ripening: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):23-29. doi: 10.1097/AOG.0000000000002403.

  PMID: 29215514 BACKGROUND

• Adhikari EH, Nelson DB, McIntire DD, Leveno KJ. Foley Bulb Added to an Oral Misoprostol Induction Protocol: A Cluster Randomized Trial. Obstet Gynecol. 2020 Nov;136(5):953-961. doi: 10.1097/AOG.0000000000004123.

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• Obesity. In: Cunningham F, Leveno KJ, Bloom SL, Dashe JS, Hoffman BL, Casey BM, Spong CY. eds. Williams Obstetrics, 25e. McGraw Hill; 2018.

  BACKGROUND

• Rossi RM, Requarth EW, Warshak CR, Dufendach K, Hall ES, DeFranco EA. Predictive Model for Failed Induction of Labor Among Obese Women. Obstet Gynecol. 2019 Sep;134(3):485-493. doi: 10.1097/AOG.0000000000003377.

  PMID: 31403588 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Pevzner L, Powers BL, Rayburn WF, Rumney P, Wing DA. Effects of maternal obesity on duration and outcomes of prostaglandin cervical ripening and labor induction. Obstet Gynecol. 2009 Dec;114(6):1315-1321. doi: 10.1097/AOG.0b013e3181bfb39f.

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• Ellis JA, Brown CM, Barger B, Carlson NS. Influence of Maternal Obesity on Labor Induction: A Systematic Review and Meta-Analysis. J Midwifery Womens Health. 2019 Jan;64(1):55-67. doi: 10.1111/jmwh.12935. Epub 2019 Jan 16.

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  PMID: 31188317 BACKGROUND

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• Saucedo AM, Alvarez M, Macones GA, Cahill AG, Harper LM. Optimal misoprostol dosing among patients with a body mass index greater than 30: a randomized controlled trial. Am J Obstet Gynecol. 2024 May;230(5):565.e1-565.e16. doi: 10.1016/j.ajog.2024.02.004. Epub 2024 Feb 15.

  PMID: 38367750 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Methods; Misoprostol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

Results may not be generalizable to all women undergoing induction, safety cannot be inferred as the incidence of adverse outcomes was low.

Results Point of Contact

• Title: Alexander Saucedo, MD
• Organization: University of Texas at Austin, Dell Medical School

alexander.saucedo@ascension.org

210-845-7571

Study Officials

• Lorie Harper, MD, MSCI

  Division Chief, Maternal-Fetal Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This study will be double blinded with the research participants and providers/nursing masked to the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal Fetal Medicine Division Director

Model Details: Participants are assigned to one of two groups (intervention versus control) in parallel for the duration of the study. Randomization will occur according to a predetermined computer-generated stratified randomization scheme prepared by a study statistician.

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: March 2, 2022
• Study Start: June 1, 2022
• Primary Completion: July 14, 2023
• Study Completion: July 17, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)