Clinical trial NCT05262738: Misoprostol Dosing in BMI Greater Than 30
Official title: Misoprostol Dosing in BMI Greater Than 30: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy Related
Obesity
Labor Onset and Length Abnormalities
Keywords: Induction of Labor
Cervical Ripening
Misoprostol
Obesity
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean)
timeFrame: From baseline to the time of delivery (baseline is initiation of labor induction), up to 3 days
Secondary outcomes:
measure: Interval Time From Labor Induction to Vaginal Delivery
timeFrame: From baseline (baseline is initiation of labor induction) to the time of vaginal delivery, up to 3 days
measure: Number of Cesarean Deliveries
timeFrame: Assessed following delivery, through study completion which is estimated at 1 year.
measure: Number of Participants Exhibiting Uterine Tachysystole
timeFrame: Assessed 4 hours post-misoprostol placement
measure: Number of Participants Exhibiting Uterine Tachysystole With Fetal Decelerations
timeFrame: Assessed 4 hours post-misoprostol placement
measure: Number of Participants Receiving Terbutaline
timeFrame: From baseline to the time of delivery
measure: Number of Participants Diagnosed With Clinical Chorioamnionitis
timeFrame: From baseline to the time of delivery
measure: Number of Participants Diagnosed With Postpartum Hemorrhage
timeFrame: Assessed at time of delivery
measure: Patient Satisfaction Six Simple Questions, Question 1
timeFrame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
measure: Patient Satisfaction Six Simple Questions, Question 2
timeFrame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
measure: Patient Satisfaction Six Simple Questions, Question 3
timeFrame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
measure: Patient Satisfaction Six Simple Questions, Question 4
timeFrame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
measure: Patient Satisfaction Six Simple Questions, Question 5
timeFrame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
measure: Patient Satisfaction Six Simple Questions, Question 6
timeFrame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
measure: Patient Satisfaction (Labor Pain Scale, Question 1)
timeFrame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
measure: Patient Satisfaction (Labor Pain Scale, Question 2)
timeFrame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
measure: Patient Satisfaction (Labor Pain Scale, Question 3)
timeFrame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
measure: Patient Satisfaction (Labor Pain Scale, Question 4)
timeFrame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin Dell Medical School, Department of Women's Health
state: Texas
Study officials:
affiliation: Division Chief, Maternal-Fetal Medicine
name: Lorie Harper, MD, MSCI
role: STUDY_DIRECTOR
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