Misoprostol Dosing in BMI Greater Than 30

University of Texas at Austin180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

Interventions

50 Micrograms Vaginal Misoprostol (Intervention)DRUG

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

25 Micrograms Vaginal Misoprostol (Control)DRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

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

Austin, Texas, United States

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Interval Time From Labor Induction to Vaginal Delivery

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

Number of Cesarean Deliveries

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

Number of Participants Exhibiting Uterine Tachysystole

Tachysystole is defined as greater than or equal to 5 contractions within a 10 minute period

Time frame: Assessed 4 hours post-misoprostol placement

Number of Participants Exhibiting Uterine Tachysystole With Fetal Decelerations

Tachysystole is defined as greater than or equal to 5 contractions within a 10 minute period. Decelerations are defined by the 2008 NICHD Fetal Monitoring Terminology.

Time frame: Assessed 4 hours post-misoprostol placement

Number of Participants Receiving Terbutaline

Time frame: From baseline to the time of delivery

Number of Participants Diagnosed With Clinical Chorioamnionitis

Time frame: From baseline to the time of delivery

Number of Participants Diagnosed With Postpartum Hemorrhage

Time frame: Assessed at time of delivery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Patient Satisfaction Six Simple Questions, Question 1

Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 1: Experience has shown that I can have appropriate and adequate control over my care. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1