Trial Outcomes & Findings for Misoprostol Dosing in BMI Greater Than 30 (NCT NCT05262738)

NCT ID: NCT05262738

Last Updated: 2024-07-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 180 participants
• Primary outcome timeframe: From baseline to the time of delivery (baseline is initiation of labor induction), up to 3 days
• Results posted on: 2024-07-03

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	92	88
Overall Study COMPLETED	91	88
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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.	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.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Misoprostol Dosing in BMI Greater Than 30

Baseline characteristics by cohort

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.	Total n=179 Participants Total of all reporting groups
Age, Continuous	28.63 years STANDARD_DEVIATION 7.48 • n=5 Participants	27.49 years STANDARD_DEVIATION 6.73 • n=7 Participants	28.07 years STANDARD_DEVIATION 7.12 • n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants	88 Participants n=7 Participants	179 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	66 Participants n=5 Participants	64 Participants n=7 Participants	130 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	79 Participants n=5 Participants	77 Participants n=7 Participants	156 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Nulliparous	55 Participants n=5 Participants	51 Participants n=7 Participants	106 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to the time of delivery (baseline is initiation of labor induction), up to 3 days

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean)	18.56 hours Standard Deviation 9.92	21.59 hours Standard Deviation 11.11

SECONDARY outcome

Timeframe: From baseline (baseline is initiation of labor induction) to the time of vaginal delivery, up to 3 days

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Interval Time From Labor Induction to Vaginal Delivery	17.20 hours Standard Deviation 9.22	19.00 hours Standard Deviation 10.76

SECONDARY outcome

Timeframe: Assessed following delivery, through study completion which is estimated at 1 year.

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Number of Cesarean Deliveries	25 Participants	24 Participants

SECONDARY outcome

Timeframe: Assessed 4 hours post-misoprostol placement

Tachysystole is defined as greater than or equal to 5 contractions within a 10 minute period

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Number of Participants Exhibiting Uterine Tachysystole	20 Participants	9 Participants

SECONDARY outcome

Timeframe: Assessed 4 hours post-misoprostol placement

Tachysystole is defined as greater than or equal to 5 contractions within a 10 minute period. Decelerations are defined by the 2008 NICHD Fetal Monitoring Terminology.

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Number of Participants Exhibiting Uterine Tachysystole With Fetal Decelerations	2 Participants	2 Participants

SECONDARY outcome

Timeframe: From baseline to the time of delivery

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Number of Participants Receiving Terbutaline	2 Participants	1 Participants

SECONDARY outcome

Timeframe: From baseline to the time of delivery

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Number of Participants Diagnosed With Clinical Chorioamnionitis	8 Participants	10 Participants

SECONDARY outcome

Timeframe: Assessed at time of delivery

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Number of Participants Diagnosed With Postpartum Hemorrhage	12 Participants	17 Participants

SECONDARY outcome

Timeframe: Assessed postpartum day one following delivery, up to 5 days post-delivery.

Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7.

Question 1: Experience has shown that I can have appropriate and adequate control over my care.

1=strongly 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

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Patient Satisfaction Six Simple Questions, Question 1	6 score on a scale Interval 6.0 to 7.0	6 score on a scale Interval 6.0 to 7.0

SECONDARY outcome

Timeframe: Assessed postpartum day one following delivery, up to 5 days post-delivery.

Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7.

Question 2: The person(s) responsible for my care are/were caring and compassionate.

1=strongly 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

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Patient Satisfaction Six Simple Questions, Question 2	7 score on a scale Interval 6.0 to 7.0	7 score on a scale Interval 6.0 to 7.0

SECONDARY outcome

Timeframe: Assessed postpartum day one following delivery, up to 5 days post-delivery.

Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7.

Question 3: Problems that have arisen up to now have not been dealt with effectively.

1=strongly 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

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Patient Satisfaction Six Simple Questions, Question 3	2 score on a scale Interval 1.0 to 4.0	2 score on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Assessed postpartum day one following delivery, up to 5 days post-delivery.

Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7.

Question 4: My needs have been addressed with appropriate consideration for my time.

1=strongly 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

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Patient Satisfaction Six Simple Questions, Question 4	6 score on a scale Interval 6.0 to 7.0	7 score on a scale Interval 6.0 to 7.0

SECONDARY outcome

Timeframe: Assessed postpartum day one following delivery, up to 5 days post-delivery.

Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7.

Question 5: The overall organization of my care has not been appropriate.

1=strongly 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

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Patient Satisfaction Six Simple Questions, Question 5	2 score on a scale Interval 1.0 to 2.0	2 score on a scale Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: Assessed postpartum day one following delivery, up to 5 days post-delivery.

Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7.

Question 6: I would choose the same type of care for my next pregnancy.

1=strongly 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

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Patient Satisfaction Six Simple Questions, Question 6	7 score on a scale Interval 6.0 to 7.0	6.5 score on a scale Interval 6.0 to 7.0

SECONDARY outcome

Timeframe: Assessed postpartum day one following delivery, up to 5 days post-delivery.

Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend.

Questions 1: Worst amount of pain experienced during labor. Scale 0-10. 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

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Patient Satisfaction (Labor Pain Scale, Question 1)	8 score on a scale Interval 5.0 to 9.0	8 score on a scale Interval 5.0 to 9.0

SECONDARY outcome

Timeframe: Assessed postpartum day one following delivery, up to 5 days post-delivery.

Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend.

Questions 2: Overall pain that you experienced during labor. Scale 0-10. 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

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Patient Satisfaction (Labor Pain Scale, Question 2)	6 score on a scale Interval 5.0 to 9.0	6.5 score on a scale Interval 5.0 to 9.0

SECONDARY outcome

Timeframe: Assessed postpartum day one following delivery, up to 5 days post-delivery.

Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend.

Questions 3: Worst amount of pain you experienced following placement of the misoprostol

Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 10 patient satisfaction.

Ranges: 0-10 Best score: 10 Worst score: 0

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Patient Satisfaction (Labor Pain Scale, Question 3)	5 score on a scale Interval 4.0 to 7.0	5 score on a scale Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: Assessed postpartum day one following delivery, up to 5 days post-delivery.

Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend.

Questions 4: How likely are you to recommend your method of induction to a friend or family member? Please rate from 0 (strongly recommend) to 10 (strongly DO NOT recommend).

Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 10 patient satisfaction.

Ranges: 0-10 Best score: 0 Worst score: 10

Outcome measures

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 Participants 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 Participants 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.
Patient Satisfaction (Labor Pain Scale, Question 4)	2 score on a scale Interval 0.0 to 5.0	2 score on a scale Interval 1.0 to 5.0

Adverse Events

50 Micrograms Vaginal Misoprostol (Intervention)

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

25 Micrograms Vaginal Misoprostol (Control)

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 participants at risk 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 participants at risk 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.
Pregnancy, puerperium and perinatal conditions Maternal ICU admission	0.00% 0/91 • through study completion, an average of 1 week. Definitions do not differ	1.1% 1/88 • Number of events 1 • through study completion, an average of 1 week. Definitions do not differ
Pregnancy, puerperium and perinatal conditions Neonatal ICU Admission	2.2% 2/91 • Number of events 2 • through study completion, an average of 1 week. Definitions do not differ	4.5% 4/88 • Number of events 4 • through study completion, an average of 1 week. Definitions do not differ

Other adverse events

Measure	50 Micrograms Vaginal Misoprostol (Intervention) n=91 participants at risk 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.	25 Micrograms Vaginal Misoprostol (Control) n=88 participants at risk 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.
Pregnancy, puerperium and perinatal conditions postpartum hemorrhage	13.2% 12/91 • Number of events 12 • through study completion, an average of 1 week. Definitions do not differ	19.3% 17/88 • Number of events 17 • through study completion, an average of 1 week. Definitions do not differ
Surgical and medical procedures wound complication	1.1% 1/91 • Number of events 1 • through study completion, an average of 1 week. Definitions do not differ	0.00% 0/88 • through study completion, an average of 1 week. Definitions do not differ
Pregnancy, puerperium and perinatal conditions clinical endometritis	3.3% 3/91 • Number of events 3 • through study completion, an average of 1 week. Definitions do not differ	2.3% 2/88 • Number of events 2 • through study completion, an average of 1 week. Definitions do not differ
Infections and infestations sepsis	0.00% 0/91 • through study completion, an average of 1 week. Definitions do not differ	1.1% 1/88 • Number of events 1 • through study completion, an average of 1 week. Definitions do not differ
Blood and lymphatic system disorders pRBC transfusion	2.2% 2/91 • Number of events 2 • through study completion, an average of 1 week. Definitions do not differ	3.4% 3/88 • Number of events 3 • through study completion, an average of 1 week. Definitions do not differ

Additional Information

Alexander Saucedo, MD

University of Texas at Austin, Dell Medical School

Phone: 210-845-7571

Email: alexander.saucedo@ascension.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place