Misoprostol Dosing in BMI Greater Than 30

Obesity Clinical Trial

— MD30 RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05262738
• Other study ID #: STUDY00002350
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2022
• Est. completion date: July 17, 2023

Study information

• Verified date: July 2023
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 17, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Labor Onset and Length Abnormalities
• Obesity
• Pregnancy Related

Intervention

Drug:
• 50 Micrograms Vaginal Misoprostol (Intervention)
Subjects will undergo cervical ripening with 50 micrograms of vaginal misoprostol every 4 hours.
• 25 Micrograms Vaginal Misoprostol (Control)
Subjects will undergo cervical ripening with 25 micrograms of vaginal misoprostol every 4 hours.

Locations

Country	Name	City	State
United States	University of Texas at Austin Dell Medical School, Department of Women's Health	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

References & Publications (25)

ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1002/(SICI)1520-6661(199905/06)8:33.0.CO;2-5. — View Citation

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. — View Citation

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. doi: 10.1016/s0002-9378(97)70199-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Harvey S, Rach D, Stainton MC, Jarrell J, Brant R. Evaluation of satisfaction with midwifery care. Midwifery. 2002 Dec;18(4):260-7. doi: 10.1054/midw.2002.0317. — View Citation

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. — View Citation

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. doi: 10.1097/AOG.0000000000001778. — View Citation

Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2019. Natl Vital Stat Rep. 2021 Apr;70(2):1-51. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1016/s0029-7844(01)01644-1. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of Vaginal Deliveries		Assessed following delivery, through study completion which is estimated at 1 year.
Secondary	Number of Cesarean Deliveries		Assessed following delivery, through study completion which is estimated at 1 year.
Secondary	Indication for Cesarean Delivery (if applicable)		Assessed at time of delivery
Secondary	Number of Operative Deliveries		Assessed following delivery, through study completion which is estimated at 1 year.
Secondary	Number of Participants exhibiting Uterine Tachysystole	Tachysystole is defined as greater than or equal to 5 contractions within a 10 minute period	Assessed 4 hours post-misoprostol placement
Secondary	Number of Participants exhibiting Uterine Tachysystole with Fetal Decelerations	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
Secondary	Number of Participants receiving Terbutaline		From baseline to the time of delivery
Secondary	Number of Participants exhibiting Non-Reassuring Fetal Heart Tracings	Fetal Heart Tracings are defined by the 2008 NICHD Fetal Monitoring Terminology.	From baseline to the time of delivery
Secondary	Number of Participants diagnosed with Clinical Chorioamnionitis		From baseline to the time of delivery
Secondary	Number of Participants diagnosed with Postpartum hemorrhage		Assessed at time of delivery
Secondary	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.
Secondary	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)	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.
Secondary	Patient Satisfaction Six Simple Questions, Question 1	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.
Secondary	Patient Satisfaction Six Simple Questions, Question 2	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.
Secondary	Patient Satisfaction Six Simple Questions, Question 3	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.
Secondary	Patient Satisfaction Six Simple Questions, Question 4	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.
Secondary	Patient Satisfaction Six Simple Questions, Question 5	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.
Secondary	Patient Satisfaction Six Simple Questions, Question 6	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.
Secondary	Patient Satisfaction (Labor Pain Scale, Question 1)	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.
Secondary	Patient Satisfaction (Labor Pain Scale, Question 2)	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.
Secondary	Patient Satisfaction (Labor Pain Scale, Question 3)	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.
Secondary	Patient Satisfaction (Labor Pain Scale, Question 4)	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.