Misoprostol Dosing in BMI Greater Than 30

Phase 4

Completed

Conditions: Pregnancy Related
Obesity
Labor Onset and Length Abnormalities

Interventions: Drug: 50 Micrograms Vaginal Misoprostol (Intervention)
Drug: 25 Micrograms Vaginal Misoprostol (Control)

Registration Number: NCT05262738

Lead Sponsor: University of Texas at Austin

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50 Micrograms Vaginal Misoprostol (Intervention)	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.
25 Micrograms Vaginal Misoprostol (Control)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Participants Exhibiting Uterine Tachysystole With Fetal Decelerations	Assessed 4 hours post-misoprostol placement	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.
Number of Participants Receiving Terbutaline	From baseline to the time of delivery
Number of Participants Diagnosed With Clinical Chorioamnionitis	From baseline to the time of delivery
Number of Participants Diagnosed With Postpartum Hemorrhage	Assessed at time of delivery
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
Patient Satisfaction Six Simple Questions, Question 1	Assessed postpartum day one following delivery, up to 5 days post-delivery.	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
Patient Satisfaction Six Simple Questions, Question 2	Assessed postpartum day one following delivery, up to 5 days post-delivery.	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 2: The person(s) responsible for my care are/were caring and compassionate. 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
Patient Satisfaction Six Simple Questions, Question 3	Assessed postpartum day one following delivery, up to 5 days post-delivery.	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 3: Problems that have arisen up to now have not been dealt with effectively. 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
Patient Satisfaction Six Simple Questions, Question 4	Assessed postpartum day one following delivery, up to 5 days post-delivery.	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 4: My needs have been addressed with appropriate consideration for my time. 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
Patient Satisfaction Six Simple Questions, Question 5	Assessed postpartum day one following delivery, up to 5 days post-delivery.	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 5: The overall organization of my care has not been appropriate. 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
Patient Satisfaction Six Simple Questions, Question 6	Assessed postpartum day one following delivery, up to 5 days post-delivery.	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 6: I would choose the same type of care for my next pregnancy. 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
Patient Satisfaction (Labor Pain Scale, Question 1)	Assessed postpartum day one following delivery, up to 5 days post-delivery.	Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend. Questions 1: Worst amount of pain experienced during labor. Scale 0-10. 0 = no pain, 10 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 10 patient satisfaction. Ranges: 0-10 Best score: 10 Worst score: 0
Patient Satisfaction (Labor Pain Scale, Question 2)	Assessed postpartum day one following delivery, up to 5 days post-delivery.	Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend. Questions 2: Overall pain that you experienced during labor. Scale 0-10. 0 = no pain, 10 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 10 patient satisfaction. Ranges: 0-10 Best score: 10 Worst score: 0
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	Tachysystole is defined as greater than or equal to 5 contractions within a 10 minute period
Patient Satisfaction (Labor Pain Scale, Question 3)	Assessed postpartum day one following delivery, up to 5 days post-delivery.	Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend. Questions 3: Worst amount of pain you experienced following placement of the misoprostol Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 10 patient satisfaction. Ranges: 0-10 Best score: 10 Worst score: 0
Patient Satisfaction (Labor Pain Scale, Question 4)	Assessed postpartum day one following delivery, up to 5 days post-delivery.	Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend. Questions 4: How likely are you to recommend your method of induction to a friend or family member? Please rate from 0 (strongly recommend) to 10 (strongly DO NOT recommend). Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 10 patient satisfaction. Ranges: 0-10 Best score: 0 Worst score: 10