Pregnancy RelatedPhase 4MD30 RCTNCT05262738
Misoprostol Dosing in BMI Greater Than 30
A Phase 4 study testing 50 Micrograms Vaginal Misoprostol (Intervention) in people with Pregnancy Related and Obesity, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Obesity, Labor Onset and Length Abnormalities
- What is being tested?
- 50 Micrograms Vaginal Misoprostol (Intervention)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 17 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Austin Dell Medical School, Department of Women's Health
Austin, Texas, 78705
About this study
Official title: Misoprostol Dosing in BMI Greater Than 30: A Randomized Controlled Trial
The investigators are performing a randomized controlled-trial investigating if 50mcg (compared to 25 mcg) of vaginal misoprostol reduces the time from induction start to delivery in obese women.
Read the 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.
- Being tested
- 50 Micrograms Vaginal Misoprostol (Intervention), 25 Micrograms Vaginal Misoprostol (Control)
- Keywords
- Induction of Labor, Cervical Ripening, Misoprostol, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 Micrograms Vaginal Misoprostol (Intervention)Drug
Also called Cytotec
Subjects will undergo cervical ripening with 50 micrograms of vaginal misoprostol every 4 hours.
25 Micrograms Vaginal Misoprostol (Control)Drug
Also called Cytotec
Subjects will undergo cervical ripening with 25 micrograms of vaginal misoprostol every 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 50 Micrograms Vaginal Misoprostol (Intervention) |
| 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. Receives: Drug: 25 Micrograms Vaginal Misoprostol (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean)
Measured: From baseline to the time of delivery (baseline is initiation of labor induction), up to 3 days
Secondary outcomes (17)
Interval Time From Labor Induction to Vaginal Delivery
Measured: From baseline (baseline is initiation of labor induction) to the time of vaginal delivery, up to 3 days
Number of Cesarean Deliveries
Measured: Assessed following delivery, through study completion which is estimated at 1 year.
Number of Participants Exhibiting Uterine Tachysystole
Tachysystole is defined as greater than or equal to 5 contractions within a 10 minute period
Measured: 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.
Measured: Assessed 4 hours post-misoprostol placement
Number of Participants Receiving Terbutaline
Measured: From baseline to the time of delivery
Number of Participants Diagnosed With Clinical Chorioamnionitis
Measured: From baseline to the time of delivery
Number of Participants Diagnosed With Postpartum Hemorrhage
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Assessed postpartum day one following delivery, up to 5 days post-delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Jun 2022
- Primary completion14 Jul 2023
- Study completion17 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorie Harper, University of Texas at Austin
- Investigators
- Lorie Harper, MD, MSCI, Study director, Division Chief, Maternal-Fetal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262738
- Sponsor's protocol ID
- STUDY00002350
- Acronym
- MD30 RCT
- Status last verified
- Jun 2024
- First submitted
- 25 Jan 2022
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30089070McDonagh 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.
PubMed 33752219Carbone 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.
PubMed 23303106Viteri 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.
PubMed 32299108Al-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.
PubMed 29215514Adhikari 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.
PubMed 33030881Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2019. Natl Vital Stat Rep. 2021 Apr;70(2):1-51.
PubMed 33814033Obesity. In: Cunningham F, Leveno KJ, Bloom SL, Dashe JS, Hoffman BL, Casey BM, Spong CY. eds. Williams Obstetrics, 25e. McGraw Hill; 2018.
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.
PubMed 31403588Knutson, 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
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
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.
PubMed 19935035Ellis 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.
PubMed 30648804Wolfe 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.
PubMed 21621187Grobman 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.
PubMed 29138035
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol Dosing in BMI Greater Than 30: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05262738
- Acronym / sponsor ID
- MD30 RCT / STUDY00002350
- Keywords
- Induction of Labor, Cervical Ripening, Misoprostol, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Experimental | Drug: 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. |
| 25 Micrograms Vaginal Misoprostol (Control) | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention)Also: CytotecSubjects will undergo cervical ripening with 50 micrograms of vaginal misoprostol every 4 hours. | Drug | 50 Micrograms Vaginal Misoprostol (Intervention) |
| 25 Micrograms Vaginal Misoprostol (Control)Also: CytotecSubjects will undergo cervical ripening with 25 micrograms of vaginal misoprostol every 4 hours. | Drug | 25 Micrograms Vaginal Misoprostol (Control) |
Primary outcome
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
17 secondary outcomes
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
Number of Cesarean Deliveries
Time frame: Assessed following delivery, through study completion which is estimated at 1 year.
Number of Participants Exhibiting Uterine Tachysystole
Time frame: Assessed 4 hours post-misoprostol placement
Number of Participants Exhibiting Uterine Tachysystole With Fetal Decelerations
Time frame: Assessed 4 hours post-misoprostol placement
Number of Participants Receiving Terbutaline
Time frame: From baseline to the time of delivery
Number of Participants Diagnosed With Clinical Chorioamnionitis
Time frame: From baseline to the time of delivery
Number of Participants Diagnosed With Postpartum Hemorrhage
Time frame: Assessed at time of delivery
Patient Satisfaction Six Simple Questions, Question 1
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction Six Simple Questions, Question 2
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction Six Simple Questions, Question 3
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction Six Simple Questions, Question 4
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction Six Simple Questions, Question 5
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction Six Simple Questions, Question 6
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction (Labor Pain Scale, Question 1)
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction (Labor Pain Scale, Question 2)
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction (Labor Pain Scale, Question 3)
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
Patient Satisfaction (Labor Pain Scale, Question 4)
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30089070Grobman 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.
- Background: PubMed 33752219McDonagh 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.
- Background: PubMed 23303106Carbone 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.
- Background: PubMed 32299108Viteri 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.
- Background: PubMed 29215514Al-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.
- Background: PubMed 33030881Adhikari 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.
- Background: PubMed 33814033Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2019. Natl Vital Stat Rep. 2021 Apr;70(2):1-51.
- BackgroundObesity. In: Cunningham F, Leveno KJ, Bloom SL, Dashe JS, Hoffman BL, Casey BM, Spong CY. eds. Williams Obstetrics, 25e. McGraw Hill; 2018.
- Background: PubMed 31403588Rossi 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.
- BackgroundKnutson, 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
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorie Harper, MD, MSCI study director
Division Chief, Maternal-Fetal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 50 Micrograms Vaginal Misoprostol (Intervention) in people with Pregnancy Related and Obesity, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05262738, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.