Misoprostol Dosing in BMI Greater Than 30 (MD30 RCT)

July 20, 2023 updated by: Lorie Harper, University of Texas at Austin

Misoprostol Dosing in BMI Greater Than 30: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78705
        • University of Texas at Austin Dell Medical School, Department of Women's Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 50 Micrograms Vaginal Misoprostol (Intervention)
Subjects will undergo cervical ripening with 50 micrograms of vaginal misoprostol every 4 hours.
Other Names:
  • Cytotec
Active Comparator: 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.
Drug: 25 Micrograms Vaginal Misoprostol (Control)
Subjects will undergo cervical ripening with 25 micrograms of vaginal misoprostol every 4 hours.
Other Names:
  • Cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From baseline to the time of delivery (baseline is initiation of labor induction), up to 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interval time from labor induction initiation to complete cervical dilation
Time Frame: From baseline to complete cervical dilation (baseline is initiation of labor induction), up to 3 days
From baseline to complete cervical dilation (baseline is initiation of labor induction), up to 3 days
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
From baseline (baseline is initiation of labor induction) to the time of vaginal delivery, up to 3 days
Number of Vaginal Deliveries
Time Frame: Assessed following delivery, through study completion which is estimated at 1 year.
Assessed following delivery, through study completion which is estimated at 1 year.
Number of Cesarean Deliveries
Time Frame: Assessed following delivery, through study completion which is estimated at 1 year.
Assessed following delivery, through study completion which is estimated at 1 year.
Indication for Cesarean Delivery (if applicable)
Time Frame: Assessed at time of delivery
Assessed at time of delivery
Number of Operative Deliveries
Time Frame: Assessed following delivery, through study completion which is estimated at 1 year.
Assessed following delivery, through study completion which is estimated at 1 year.
Number of Participants exhibiting Uterine Tachysystole
Time Frame: Assessed 4 hours post-misoprostol placement
Tachysystole is defined as greater than or equal to 5 contractions within a 10 minute period
Assessed 4 hours post-misoprostol placement
Number of Participants exhibiting Uterine Tachysystole with Fetal Decelerations
Time Frame: 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.
Assessed 4 hours post-misoprostol placement
Number of Participants receiving Terbutaline
Time Frame: From baseline to the time of delivery
From baseline to the time of delivery
Number of Participants exhibiting Non-Reassuring Fetal Heart Tracings
Time Frame: From baseline to the time of delivery
Fetal Heart Tracings are defined by the 2008 NICHD Fetal Monitoring Terminology.
From baseline to the time of delivery
Number of Participants diagnosed with Clinical Chorioamnionitis
Time Frame: From baseline to the time of delivery
From baseline to the time of delivery
Number of Participants diagnosed with Postpartum hemorrhage
Time Frame: Assessed at time of delivery
Assessed at time of delivery
Composite Maternal Morbidity (ICU admission, Sepsis, Need for Transfusion, Death)
Time Frame: From baseline (baseline is initiation of labor induction) until delivery, up to 5 days post-delivery.
From baseline (baseline is initiation of labor induction) until delivery, up to 5 days post-delivery.
Composite Neonatal Morbidity (ICU admission, APGAR <=7 at 5 minutes, Sepsis, Acidemia identified upon cord collection (pH < 7.15, Base Deficit >12.0 mmol), Induced Hypothermia, Perinatal Death)
Time Frame: Assessed at time of delivery, up to 30 days post-delivery.
Apgar scores are assigned to all births. These are universally performed and assigned in the United States. The scoring system is between 0-10. 0 is the minimum score and 10 is the maximum. Lower scores are worse than higher scores. Base deficit is a lab value.
Assessed at time of delivery, up to 30 days post-delivery.
Patient Satisfaction Six Simple Questions, Question 1
Time Frame: 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 agree, 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
Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction Six Simple Questions, Question 2
Time Frame: 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 agree, 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
Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction Six Simple Questions, Question 3
Time Frame: 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 agree, 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
Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction Six Simple Questions, Question 4
Time Frame: 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 agree, 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
Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction Six Simple Questions, Question 5
Time Frame: 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 agree, 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
Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction Six Simple Questions, Question 6
Time Frame: 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 agree, 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
Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction (Labor Pain Scale, Question 1)
Time Frame: 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. 1 = 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
Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction (Labor Pain Scale, Question 2)
Time Frame: 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. 1 = 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
Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction (Labor Pain Scale, Question 3)
Time Frame: 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
Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction (Labor Pain Scale, Question 4)
Time Frame: 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: 10 Worst score: 0
Assessed postpartum day one following delivery, up to 5 days post-delivery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Investigators

  • Study Director: Lorie Harper, MD, MSCI, Division Chief, Maternal-Fetal Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

July 14, 2023

Study Completion (Actual)

July 17, 2023

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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