MD30 RCT: Misoprostol Dosing in BMI Greater Than 30

• Sponsor: University of Texas at Austin (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05262738
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 18

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related; Obesity; Labor Onset and Length Abnormalities	Drug: 50 Micrograms Vaginal Misoprostol (Intervention); Drug: 25 Micrograms Vaginal Misoprostol (Control)	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Double (Participant, Care Provider)
• Masking Description: This study will be double blinded with the research participants and providers/nursing masked to the interventions.
• Primary Purpose: Treatment
• Official Title: Misoprostol Dosing in BMI Greater Than 30: A Randomized Controlled Trial
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Interval time from labor induction initiation to complete cervical dilation [From baseline to complete cervical dilation (baseline is initiation of labor induction), up to 3 days]

2. 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]

3. Number of Vaginal Deliveries [Assessed following delivery, through study completion which is estimated at 1 year.]

4. Number of Cesarean Deliveries [Assessed following delivery, through study completion which is estimated at 1 year.]

5. Indication for Cesarean Delivery (if applicable) [Assessed at time of delivery]

6. Number of Operative Deliveries [Assessed following delivery, through study completion which is estimated at 1 year.]

7. 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

8. 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.

9. Number of Participants receiving Terbutaline [From baseline to the time of delivery]

10. Number of Participants exhibiting Non-Reassuring Fetal Heart Tracings [From baseline to the time of delivery]

    Fetal Heart Tracings are defined by the 2008 NICHD Fetal Monitoring Terminology.

11. Number of Participants diagnosed with Clinical Chorioamnionitis [From baseline to the time of delivery]

12. Number of Participants diagnosed with Postpartum hemorrhage [Assessed at time of delivery]

13. Composite Maternal Morbidity (ICU admission, Sepsis, Need for Transfusion, Death) [From baseline (baseline is initiation of labor induction) until delivery, up to 5 days post-delivery.]

14. 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) [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.

15. 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 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

16. 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 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

17. 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 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

18. 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 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

19. 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 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

20. 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 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

21. 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. 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

22. 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. 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

23. 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

24. 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: 10 Worst score: 0

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas at Austin Dell Medical School, Department of Women's Health	Austin	Texas	United States	78705

Sponsors and Collaborators

• University of Texas at Austin

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. Review.
• Adhikari EH, Nelson DB, McIntire DD, Leveno KJ. Foley Bulb Added to an Oral Misoprostol Induction Protocol: A Cluster Randomized Trial. Obstet Gynecol. 2020 Nov;136(5):953-961. doi: 10.1097/AOG.0000000000004123.
• Al-Ibraheemi Z, Brustman L, Bimson BE, Porat N, Rosenn B. Misoprostol With Foley Bulb Compared With Misoprostol Alone for Cervical Ripening: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):23-29. doi: 10.1097/AOG.0000000000002403.
• Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
• Diro M, Adra A, Gilles JM, Nassar A, Rodriguez A, Salamat SM, Beydoun SN, O'Sullivan MJ, Yasin SY, Burkett G. A double-blind randomized trial of two dose regimens of misoprostol for cervical ripening and labor induction. J Matern Fetal Med. 1999 May-Jun;8(3):114-8.
• Ellis JA, Brown CM, Barger B, Carlson NS. Influence of Maternal Obesity on Labor Induction: A Systematic Review and Meta-Analysis. J Midwifery Womens Health. 2019 Jan;64(1):55-67. doi: 10.1111/jmwh.12935. Epub 2019 Jan 16.
• Farah LA, Sanchez-Ramos L, Rosa C, Del Valle GO, Gaudier FL, Delke I, Kaunitz AM. Randomized trial of two doses of the prostaglandin E1 analog misoprostol for labor induction. Am J Obstet Gynecol. 1997 Aug;177(2):364-9; discussion 369-71.
• Grobman WA, Bailit J, Lai Y, Reddy UM, Wapner RJ, Varner MW, Thorp JM Jr, Leveno KJ, Caritis SN, Prasad M, Tita ATN, Saade G, Sorokin Y, Rouse DJ, Blackwell SC, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Defining failed induction of labor. Am J Obstet Gynecol. 2018 Jan;218(1):122.e1-122.e8. doi: 10.1016/j.ajog.2017.11.556. Epub 2017 Nov 11.
• Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.
• Handal-Orefice RC, Friedman AM, Chouinard SM, Eke AC, Feinberg B, Politch J, Iverson RE, Yarrington CD. Oral or Vaginal Misoprostol for Labor Induction and Cesarean Delivery Risk. Obstet Gynecol. 2019 Jul;134(1):10-16. doi: 10.1097/AOG.0000000000003274.
• Harvey S, Rach D, Stainton MC, Jarrell J, Brant R. Evaluation of satisfaction with midwifery care. Midwifery. 2002 Dec;18(4):260-7.
• Knutson, Karin Britta MD; Leung, Katherine MPH; Allocco, Elizabeth Rose MD; Minor, Kathleen MD; Delpapa, Ellen MD; Lauring, Julianne MD Time to Delivery Following Induction of Labor in Obese Versus Normal-Weight Women [11S], Obstetrics & Gynecology: May 2019 - Volume 133 - Issue - p 205S
• Lenoir-Wijnkoop I, van der Beek EM, Garssen J, Nuijten MJ, Uauy RD. Health economic modeling to assess short-term costs of maternal overweight, gestational diabetes, and related macrosomia - a pilot evaluation. Front Pharmacol. 2015 May 20;6:103. doi: 10.3389/fphar.2015.00103. eCollection 2015.
• Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364.
• Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2019. Natl Vital Stat Rep. 2021 Apr;70(2):1-51.
• McDonagh M, Skelly AC, Tilden E, Brodt ED, Dana T, Hart E, Kantner SN, Fu R, Hermesch AC. Outpatient Cervical Ripening: A Systematic Review and Meta-analysis. Obstet Gynecol. 2021 Jun 1;137(6):1091-1101. doi: 10.1097/AOG.0000000000004382.
• Norman SM, Tuuli MG, Odibo AO, Caughey AB, Roehl KA, Cahill AG. The effects of obesity on the first stage of labor. Obstet Gynecol. 2012 Jul;120(1):130-5. doi: 10.1097/AOG.0b013e318259589c.
• Obesity. In: Cunningham F, Leveno KJ, Bloom SL, Dashe JS, Hoffman BL, Casey BM, Spong CY. eds. Williams Obstetrics, 25e. McGraw Hill; 2018.
• Pevzner L, Powers BL, Rayburn WF, Rumney P, Wing DA. Effects of maternal obesity on duration and outcomes of prostaglandin cervical ripening and labor induction. Obstet Gynecol. 2009 Dec;114(6):1315-1321. doi: 10.1097/AOG.0b013e3181bfb39f.
• Rossi RM, Requarth EW, Warshak CR, Dufendach K, Hall ES, DeFranco EA. Predictive Model for Failed Induction of Labor Among Obese Women. Obstet Gynecol. 2019 Sep;134(3):485-493. doi: 10.1097/AOG.0000000000003377.
• Sanchez-Ramos L, Kaunitz AM, Delke I. Labor induction with 25 microg versus 50 microg intravaginal misoprostol: a systematic review. Obstet Gynecol. 2002 Jan;99(1):145-51. Review.
• Staudenmaier, Emily K. DO; Chatterton, Carolyn G. DO, MPH; Montanez, Marelli DO; Sampino, Isabella; Vullo, John J. DO; Gurram, Padmalatha MD, MSCTR Induction of Labor Compared With Expectant Management and Risk of Cesarean Delivery in Obese Women [7F], Obstetrics & Gynecology: May 2019 - Volume 133 - Issue - p 63S-64S
• Stefely E, Warshak CR. Contraction frequency after administration of misoprostol in obese versus nonobese women. J Matern Fetal Neonatal Med. 2019 Nov;32(21):3526-3530. doi: 10.1080/14767058.2018.1465919. Epub 2018 Apr 30.
• Viteri OA, Tabsh KK, Alrais MA, Salazar XC, Lopez JM, Fok RY, Chauhan SP, Sibai BM. Transcervical Foley Balloon Plus Vaginal Misoprostol versus Vaginal Misoprostol Alone for Cervical Ripening in Nulliparous Obese Women: A Multicenter, Randomized, Comparative-Effectiveness Trial. Am J Perinatol. 2021 Aug;38(S 01):e123-e128. doi: 10.1055/s-0040-1708805. Epub 2020 Apr 16.
• Wolfe KB, Rossi RA, Warshak CR. The effect of maternal obesity on the rate of failed induction of labor. Am J Obstet Gynecol. 2011 Aug;205(2):128.e1-7. doi: 10.1016/j.ajog.2011.03.051. Epub 2011 Apr 8.

• Responsible Party: Lorie Harper, Maternal Fetal Medicine Division Director, University of Texas at Austin
• ClinicalTrials.gov Identifier: NCT05262738
• Other Study ID Numbers: STUDY00002350
• First Posted: Mar 2, 2022
• Last Update Posted: Jun 6, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Lorie Harper, Maternal Fetal Medicine Division Director, University of Texas at Austin: Induction of Labor; Cervical Ripening; Misoprostol; Obesity
• Additional relevant MeSH terms: Obesity; Misoprostol

Study Results

No Results Posted as of Jun 6, 2022