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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Experimental | 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) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Drug | Subjects will undergo cervical ripening with 50 micrograms of vaginal misoprostol every 4 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Number of Cesarean Deliveries | Assessed following delivery, through study completion which is estimated at 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorie Harper, MD, MSCI | Division Chief, Maternal-Fetal Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas at Austin Dell Medical School, Department of Women's Health | Austin | Texas | 78705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30089070 | Background | 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. | |
| 33752219 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 50 Micrograms Vaginal Misoprostol (Intervention): Subjects will undergo cervical ripening with 50 micrograms of vaginal misoprostol every 4 hours. |
| FG001 | 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. 25 Micrograms Vaginal Misoprostol (Control): Subjects will undergo cervical ripening with 25 micrograms of vaginal misoprostol every 4 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 50 Micrograms Vaginal Misoprostol (Intervention): Subjects will undergo cervical ripening with 50 micrograms of vaginal misoprostol every 4 hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean) | Posted | Mean | Standard Deviation | hours | From baseline to the time of delivery (baseline is initiation of labor induction), up to 3 days |
|
through study completion, an average of 1 week.
Definitions do not differ
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 50 Micrograms Vaginal Misoprostol (Intervention): Subjects will undergo cervical ripening with 50 micrograms of vaginal misoprostol every 4 hours. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Maternal ICU admission | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | ICU transfer |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
Results may not be generalizable to all women undergoing induction, safety cannot be inferred as the incidence of adverse outcomes was low.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Saucedo, MD | University of Texas at Austin, Dell Medical School | 210-845-7571 | alexander.saucedo@ascension.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2022 | Feb 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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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.
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This study will be double blinded with the research participants and providers/nursing masked to the interventions.
|
| 25 Micrograms Vaginal Misoprostol (Control) | Drug | Subjects will undergo cervical ripening with 25 micrograms of vaginal misoprostol every 4 hours. |
|
|
| 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 |
| 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 |
| 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 |
| 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 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 | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
| 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 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 | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
| 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 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 | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
| 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 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 | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
| 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 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 | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
| 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 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 | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
| 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. 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 | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
| 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. 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 | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
| 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. |
| 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: 0 Worst score: 10 | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
| Background |
| 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. |
| 23303106 | Background | 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. |
| 32299108 | Background | 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. |
| 29215514 | Background | 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. |
| 33030881 | Background | 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. |
| 33814033 | Background | Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2019. Natl Vital Stat Rep. 2021 Apr;70(2):1-51. |
| Background | Obesity. In: Cunningham F, Leveno KJ, Bloom SL, Dashe JS, Hoffman BL, Casey BM, Spong CY. eds. Williams Obstetrics, 25e. McGraw Hill; 2018. |
| 31403588 | Background | 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. |
| Background | 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 |
| Background | 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 |
| 19935035 | Background | 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. |
| 30648804 | Background | 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. |
| 21621187 | Background | 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. |
| 29138035 | Background | 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. |
| 22914401 | Background | 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. |
| 29656680 | Background | 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. |
| 19623003 | Background | 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. |
| 11777525 | Background | 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. |
| 31188317 | Background | 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. |
| 9290452 | Background | 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. |
| 10338065 | Background | 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. |
| 27824758 | Background | 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. |
| 26042038 | Background | 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. |
| 12473441 | Background | 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. |
| 38367750 | Derived | Saucedo AM, Alvarez M, Macones GA, Cahill AG, Harper LM. Optimal misoprostol dosing among patients with a body mass index greater than 30: a randomized controlled trial. Am J Obstet Gynecol. 2024 May;230(5):565.e1-565.e16. doi: 10.1016/j.ajog.2024.02.004. Epub 2024 Feb 15. |
| BG001 | 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. 25 Micrograms Vaginal Misoprostol (Control): Subjects will undergo cervical ripening with 25 micrograms of vaginal misoprostol every 4 hours. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Nulliparous | Count of Participants | Participants |
|
|
|
| Secondary | Interval Time From Labor Induction to Vaginal Delivery | Posted | Mean | Standard Deviation | hours | From baseline (baseline is initiation of labor induction) to the time of vaginal delivery, up to 3 days |
|
|
|
| Secondary | Number of Cesarean Deliveries | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | Assessed 4 hours post-misoprostol placement |
|
|
|
| Secondary | Number of Participants Receiving Terbutaline | Posted | Count of Participants | Participants | From baseline to the time of delivery |
|
|
|
| Secondary | Number of Participants Diagnosed With Clinical Chorioamnionitis | Posted | Count of Participants | Participants | From baseline to the time of delivery |
|
|
|
| Secondary | Number of Participants Diagnosed With Postpartum Hemorrhage | Posted | Count of Participants | Participants | Assessed at time of 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 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 | Posted | Median | Inter-Quartile Range | score on a scale | 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 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 | Posted | Median | Inter-Quartile Range | score on a scale | 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 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 | Posted | Median | Inter-Quartile Range | score on a scale | 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 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 | Posted | Median | Inter-Quartile Range | score on a scale | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
|
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| 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 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 | Posted | Median | Inter-Quartile Range | score on a scale | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
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| 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 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 | Posted | Median | Inter-Quartile Range | score on a scale | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
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| 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. 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 | Posted | Median | Inter-Quartile Range | score on a scale | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
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| 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. 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 | Posted | Median | Inter-Quartile Range | score on a scale | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
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| 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 | Posted | Median | Inter-Quartile Range | score on a scale | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
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| 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: 0 Worst score: 10 | Posted | Median | Inter-Quartile Range | score on a scale | Assessed postpartum day one following delivery, up to 5 days post-delivery. |
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| 0 |
| 91 |
| 2 |
| 91 |
| 18 |
| 91 |
| EG001 | 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. 25 Micrograms Vaginal Misoprostol (Control): Subjects will undergo cervical ripening with 25 micrograms of vaginal misoprostol every 4 hours. | 0 | 88 | 5 | 88 | 23 | 88 |
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| Neonatal ICU Admission | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Neonatal ICU Transfer |
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| wound complication | Surgical and medical procedures | Non-systematic Assessment |
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| clinical endometritis | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| sepsis | Infections and infestations | Non-systematic Assessment |
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| pRBC transfusion | Blood and lymphatic system disorders | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |