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Completed

NCT Number: NCT05262738

Misoprostol Dosing in BMI Greater Than 30

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.

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Key information

Conditions

Pregnancy Related Body Weight Labor Onset and Length Abnormalities Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Austin, Texas, 78705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

50 Micrograms Vaginal Misoprostol (Intervention)

Drug

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

Other names: Cytotec

25 Micrograms Vaginal Misoprostol (Control)

Drug

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

Other names: Cytotec

Primary outcomes

  1. 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

  1. 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

  2. Number of Cesarean Deliveries

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

  3. 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

  4. 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.

  5. Number of Participants Receiving Terbutaline

    Time frame: From baseline to the time of delivery

  6. Number of Participants Diagnosed With Clinical Chorioamnionitis

    Time frame: From baseline to the time of delivery

  7. Number of Participants Diagnosed With Postpartum Hemorrhage

    Time frame: Assessed at time of delivery

  8. 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 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

  9. 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 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

  10. 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 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

  11. 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 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

  12. 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 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

  13. 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 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

  14. 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. 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

  15. 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. 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

  16. 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

  17. 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: 0 Worst score: 10

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

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

Acronym: MD30 RCT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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