Misoprostol Dosing in BMI Greater Than 30

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pregnancy Related, Obesity, Labor Onset and Length Abnormalities

Intervention / Treatment
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* Drug: 50 Micrograms Vaginal Misoprostol (Intervention)
* Drug: 25 Micrograms Vaginal Misoprostol (Control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton gestation Age 18 years or older Gestational age >= 36 weeks BMI >= 30 kg/m2 at time of labor induction Cephalic presentation (including successful external cephalic version) Cervical dilation <= 3cm Intent to proceed with cervical ripening Exclusion Criteria: Contraindication to vaginal delivery (placenta previa, vasa previa, prior classical cesarean, non-vertex presentation, etc.) Contraindication to prostaglandin administration (significant allergy, prior cesarean delivery, etc.) Multiple gestations Gestational age < 36 weeks Non-reassuring fetal heart tracing Evidence of clinical chorioamnionitis Significant vaginal bleeding with concern for abruption Prior cesarean delivery or uterine surgery Major fetal anomaly or demise Cervix >3cm No intention to proceed with cervical ripening (not indicated, favorable bishop score, plan for Oxytocin administration, etc.) Uterine tachysystole (defined as >= 5 contractions within a 10m period) Fetal Growth Restriction (EFW <= 5% or elevated/absent/reversed Umbilical Artery dopplers) Inability to give consent (inability to read/write in English or Spanish)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 Micrograms Vaginal Misoprostol (Intervention)<br>Subjects in this arm will be randomized to the 50 micrograms of vaginal misoprostol (intervention) group, they will be admitted to labor and delivery and undergo placement of 50 micrograms of intravaginal misoprostol every 4 hours for cervical ripening. | Drug: 50 Micrograms Vaginal Misoprostol (Intervention)<br>* Subjects will undergo cervical ripening with 50 micrograms of vaginal misoprostol every 4 hours.<br>* Other names: Cytotec;|
| Active Comparator: 25 Micrograms Vaginal Misoprostol (Control)<br>Subjects in this arm will be randomized to the 25 micrograms of vaginal misoprostol (control) group, they will be admitted to labor and delivery and undergo placement of 25 micrograms of intravaginal misoprostol every 4 hours for cervical ripening. | Drug: 25 Micrograms Vaginal Misoprostol (Control)<br>* Subjects will undergo cervical ripening with 25 micrograms of vaginal misoprostol every 4 hours.<br>* Other names: Cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Vaginal Deliveries |  | Assessed following delivery, through study completion which is estimated at 1 year. | 
| Number of Cesarean Deliveries |  | Assessed following delivery, through study completion which is estimated at 1 year. | 
| Indication for Cesarean Delivery (if applicable) |  | Assessed at time of delivery | 
| Number of Operative Deliveries |  | 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 | 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 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 | 
| 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 | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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: 10 Worst score: 0 | Assessed postpartum day one following delivery, up to 5 days post-delivery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induction of Labor, Cervical Ripening, Misoprostol, Obesity