Trial Outcomes & Findings for Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE) (NCT NCT02408315)

NCT ID: NCT02408315

Last Updated: 2022-04-13

Results Overview

number of hours from placement of study drug to delivery Cesarean delivery for fetal non--reassurance indication

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 300 participants
• Primary outcome timeframe: from study entry until delivery- anticipated 3 days
• Results posted on: 2022-04-13

Participant Flow

Participant milestones

Measure	Buccal Misoprostol/Vaginal Placebo Misoprostol administered buccally with placebo administered vaginally.	Vaginal Misoprostol/Buccal Placebo Misoprostol administered vaginally with placebo administered buccally.
Overall Study STARTED	148	152
Overall Study COMPLETED	148	152
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)

Baseline characteristics by cohort

Measure	Buccal Misoprostol/Vaginal Placebo n=148 Participants Misoprostol administered buccally with placebo administered vaginally.	Vaginal Misoprostol/Buccal Placebo n=152 Participants Misoprostol administered vaginally with placebo administered buccally.	Total n=300 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	146 Participants n=5 Participants	150 Participants n=7 Participants	296 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	27.59 years STANDARD_DEVIATION 6.4 • n=5 Participants	28.21 years STANDARD_DEVIATION 6.4 • n=7 Participants	27.91 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	148 Participants n=5 Participants	152 Participants n=7 Participants	300 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	49 Participants n=5 Participants	45 Participants n=7 Participants	94 Participants n=5 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants	74 Participants n=7 Participants	140 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment United States	148 participants n=5 Participants	152 participants n=7 Participants	300 participants n=5 Participants

PRIMARY outcome

Timeframe: from study entry until delivery- anticipated 3 days

number of hours from placement of study drug to delivery

Cesarean delivery for fetal non--reassurance indication

Outcome measures

Measure	Buccal Misoprostol/Vaginal Placebo n=148 Participants Misoprostol administered buccally with placebo administered vaginally.	Vaginal Misoprostol/Buccal Placebo n=152 Participants Misoprostol administered vaginally with placebo administered buccally.
Time to Delivery	28.1 hours Interval 24.1 to 31.4	20.1 hours Interval 18.2 to 22.8

PRIMARY outcome

Timeframe: from study entry until delivery- anticipated 3 days

Rate of cesarean deliveries performed for fetal non-reassurance as the indication

Outcome measures

Measure	Buccal Misoprostol/Vaginal Placebo n=148 Participants Misoprostol administered buccally with placebo administered vaginally.	Vaginal Misoprostol/Buccal Placebo n=152 Participants Misoprostol administered vaginally with placebo administered buccally.
Number of Participants With Cesarean Deliveries Based on Fetal Non-Reassurance Indications	14 Participants	5 Participants

SECONDARY outcome

Timeframe: from study entry until delivery- anticipated 3 days

rate of achieving vaginal delivery within 24 hours

Outcome measures

Measure	Buccal Misoprostol/Vaginal Placebo n=148 Participants Misoprostol administered buccally with placebo administered vaginally.	Vaginal Misoprostol/Buccal Placebo n=152 Participants Misoprostol administered vaginally with placebo administered buccally.
Number of Vaginal Deliveries That Occurred Within 24 Hours	58 Participants	89 Participants

SECONDARY outcome

Timeframe: from study entry until delivery- anticipated 3 days

Presence of uterine hyperstimulation, tachysystole as defined as 6 uterine contractions in a 10 minute period

Outcome measures

Measure	Buccal Misoprostol/Vaginal Placebo n=148 Participants Misoprostol administered buccally with placebo administered vaginally.	Vaginal Misoprostol/Buccal Placebo n=152 Participants Misoprostol administered vaginally with placebo administered buccally.
Number of Participants Who Had Uterine Hyperstimulation	18 Participants	22 Participants

SECONDARY outcome

Timeframe: from study entry until discharge of newborn- anticipated up to 28 days

Admission to NICU

Outcome measures

Measure	Buccal Misoprostol/Vaginal Placebo n=148 Participants Misoprostol administered buccally with placebo administered vaginally.	Vaginal Misoprostol/Buccal Placebo n=152 Participants Misoprostol administered vaginally with placebo administered buccally.
Number of Neonatal Intensive Care Unit (NICU) Admission	30 participants	31 participants

SECONDARY outcome

Timeframe: from study entry until delivery- anticipated 3 days

Number of doses of misoprostol needed

Outcome measures

Measure	Buccal Misoprostol/Vaginal Placebo n=148 Participants Misoprostol administered buccally with placebo administered vaginally.	Vaginal Misoprostol/Buccal Placebo n=152 Participants Misoprostol administered vaginally with placebo administered buccally.
Number of Doses Misoprostol Used	3 doses Interval 1.0 to 7.0	2 doses Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: from study entry until delivery- anticipated 3 days

Presence of uterine rupture

Outcome measures

Measure	Buccal Misoprostol/Vaginal Placebo n=148 Participants Misoprostol administered buccally with placebo administered vaginally.	Vaginal Misoprostol/Buccal Placebo n=152 Participants Misoprostol administered vaginally with placebo administered buccally.
Uterine Rupture	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from study entry until delivery- anticipated 3 days

dose of oxytocin used for augmentation of labor

Outcome measures

Measure	Buccal Misoprostol/Vaginal Placebo n=148 Participants Misoprostol administered buccally with placebo administered vaginally.	Vaginal Misoprostol/Buccal Placebo n=152 Participants Misoprostol administered vaginally with placebo administered buccally.
Dose of Oxytocin Used for Augmentation	6 milliunits per minute Interval 0.0 to 30.0	4 milliunits per minute Interval 0.0 to 36.0

SECONDARY outcome

Timeframe: from study entry until delivery- anticipated 3 days

cord gases from newborn

Outcome measures

Measure	Buccal Misoprostol/Vaginal Placebo n=148 Participants Misoprostol administered buccally with placebo administered vaginally.	Vaginal Misoprostol/Buccal Placebo n=152 Participants Misoprostol administered vaginally with placebo administered buccally.
Number of Participants With Neonatal Cord Gases Measured	12 Participants	15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: from study entry until delivery- anticipated 3 days

pharmacokinetic parameters (Area under the curve, half-life, maximum concentration) measured over first 2 study drug doses

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: from study entry until discharge- anticipated 5 days

participant satisfaction with labor induction and preference for method of drug administration. This will use a questionnaire developed for this study with some similarity to the referenced Nassar study below.

Outcome measures

Outcome data not reported

Adverse Events

Buccal Misoprostol/Vaginal Placebo

Serious events: 11 serious events

Other events: 68 other events

Deaths: 0 deaths

Vaginal Misoprostol/Buccal Placebo

Serious events: 9 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Measure	Buccal Misoprostol/Vaginal Placebo n=148 participants at risk Misoprostol administered buccally with placebo administered vaginally.	Vaginal Misoprostol/Buccal Placebo n=152 participants at risk Misoprostol administered vaginally with placebo administered buccally.
General disorders Inpatient or Postpartum Hospitalization	7.4% 11/148 • Number of events 11 • Maternal and neonatal adverse events were tracked starting from the first dose and ending at neonatal discharge or thirty days of life, whichever is greater..	5.3% 8/152 • Number of events 11 • Maternal and neonatal adverse events were tracked starting from the first dose and ending at neonatal discharge or thirty days of life, whichever is greater..
Pregnancy, puerperium and perinatal conditions Other Life Threatening Event	0.00% 0/148 • Maternal and neonatal adverse events were tracked starting from the first dose and ending at neonatal discharge or thirty days of life, whichever is greater..	0.66% 1/152 • Number of events 1 • Maternal and neonatal adverse events were tracked starting from the first dose and ending at neonatal discharge or thirty days of life, whichever is greater..

Other adverse events

Measure	Buccal Misoprostol/Vaginal Placebo n=148 participants at risk Misoprostol administered buccally with placebo administered vaginally.	Vaginal Misoprostol/Buccal Placebo n=152 participants at risk Misoprostol administered vaginally with placebo administered buccally.
Pregnancy, puerperium and perinatal conditions Any Maternal or Fetal Event	45.9% 68/148 • Number of events 68 • Maternal and neonatal adverse events were tracked starting from the first dose and ending at neonatal discharge or thirty days of life, whichever is greater..	46.7% 71/152 • Number of events 71 • Maternal and neonatal adverse events were tracked starting from the first dose and ending at neonatal discharge or thirty days of life, whichever is greater..

Additional Information

Dr. David M. Haas

Indiana University School of Medicine

Phone: 317-880-3949

Email: dahaas@iu.edu

Results disclosure agreements

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