Misoprostol Dosing in BMI Greater Than 30

NCT ID: NCT05262738

Last Updated: 2024-07-03

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-07-17

Brief Summary

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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.

Detailed Description

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As of 2019, almost 1 in 4 women in the United States had their labor induced with almost 9 in 10 women requiring different methods to prepare their cervix for induction. There have been several research studies in the past designed to look at the fastest and safest method for labor induction, however very few studies have been done in women with a Body Mass Index (BMI) greater than or equal to 30 kg/m2.

Women with a BMI greater than or equal to 30 kg/m2, also classified as Obesity, are known to have longer labor induction times and experience more "failed" labor inductions requiring cesarean delivery (C-Sections). Obese women are also at a higher risk of developing complications during labor and postpartum such as excessive vaginal bleeding and infections.

Due to limited information, the American College of Obstetricians and Gynecologists (ACOG) currently recommends a standard dosing of 25 or 50 micrograms of vaginal misoprostol for labor induction in all women. However, there are studies which specifically compared the 25 microgram and 50 microgram misoprostol doses and found that women have significantly shorter time to deliveries without any harmful effects to mother or baby.

The investigators will conduct a randomized controlled trial to determine if 50 micrograms of vaginal misoprostol, when compared to the standard 25 micrograms, reduces the time from the start of labor induction to delivery in obese women. Women who are admitted to Labor \& Delivery for the purposes of labor induction will be randomized to undergo either 25 micrograms or 50 micrograms of vaginal misoprostol for cervical ripening. Women and their infants will be followed until the time of their discharge.

Conditions

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Pregnancy Related Obesity Labor Onset and Length Abnormalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
This study will be double blinded with the research participants and providers/nursing masked to the interventions.

Study Groups

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50 Micrograms Vaginal Misoprostol (Intervention)

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.

Group Type EXPERIMENTAL

50 Micrograms Vaginal Misoprostol (Intervention)

Intervention Type DRUG

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

25 Micrograms Vaginal Misoprostol (Control)

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.

Group Type ACTIVE_COMPARATOR

25 Micrograms Vaginal Misoprostol (Control)

Intervention Type DRUG

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

Interventions

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50 Micrograms Vaginal Misoprostol (Intervention)

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

Intervention Type DRUG

25 Micrograms Vaginal Misoprostol (Control)

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

Intervention Type DRUG

Other Intervention Names

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Cytotec Cytotec

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Lorie Harper

Maternal Fetal Medicine Division Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lorie Harper, MD, MSCI

Role: STUDY_DIRECTOR

Division Chief, Maternal-Fetal Medicine

Locations

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

Austin, Texas, United States

Site Status

Countries

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United States

References

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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.

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Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY00002350

Identifier Type: -

Identifier Source: org_study_id

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