Misoprostol Dosing in BMI Greater Than 30 (MD30 RCT)

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Pregnancy Related; Obesity; Labor Onset and Length Abnormalities

Treatments: Drug: 50 Micrograms Vaginal Misoprostol (Intervention); Drug: 25 Micrograms Vaginal Misoprostol (Control)

Study type: Interventional

Funder types: Other

Identifiers

NCT05262738

STUDY00002350

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 180 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

50 Micrograms Vaginal Misoprostol (Intervention)

Experimental group

Description:

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.

Treatment:

Drug: 50 Micrograms Vaginal Misoprostol (Intervention)

25 Micrograms Vaginal Misoprostol (Control)

Active Comparator group

Description:

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.

Treatment:

Drug: 25 Micrograms Vaginal Misoprostol (Control)