Trial Outcomes & Findings for A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor (NCT NCT02777190)

NCT ID: NCT02777190

Last Updated: 2022-10-13

Results Overview

Active phase of labor defined as greater than or equal to 6 cm cervical dilation

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 34 participants
• Primary outcome timeframe: from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.
• Results posted on: 2022-10-13

Participant Flow

Participant milestones

Measure	Oral Misoprostol oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol vaginal misoprostol given 25 mcg every 4 hours
Overall Study STARTED	17	17
Overall Study COMPLETED	16	11
Overall Study NOT COMPLETED	1	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor

Baseline characteristics by cohort

Measure	Oral Misoprostol n=17 Participants oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=17 Participants vaginal misoprostol given 25 mcg every 4 hours	Total n=34 Participants Total of all reporting groups
Age, Continuous	27.8 years STANDARD_DEVIATION 4.3 • n=5 Participants	26.5 years STANDARD_DEVIATION 5.7 • n=7 Participants	27.2 years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	17 Participants n=7 Participants	34 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	13 Participants n=7 Participants	26 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.

Population: Subjects who reached active phase of labor.

Active phase of labor defined as greater than or equal to 6 cm cervical dilation

Outcome measures

Measure	Oral Misoprostol n=17 Participants oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=11 Participants vaginal misoprostol given 25 mcg every 4 hours
Time to Active Labor	19.8 hours Standard Deviation 10.6	21.4 hours Standard Deviation 10.3

SECONDARY outcome

Timeframe: From start of induction of labor (first misoprostol administration) to initiation of oxytocin for labor augmentation, up to 36 hours

Population: Subjects who initiated oxytocin

The length of time (in hours) between the administration of misoprostol (first dose) and the first administration of oxytocin for labor augmentation.

Outcome measures

Measure	Oral Misoprostol n=15 Participants oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=15 Participants vaginal misoprostol given 25 mcg every 4 hours
Time to Initiation of Oxytocin for Labor Augmentation	11.0 hours Standard Deviation 6.8	12.6 hours Standard Deviation 6.8

SECONDARY outcome

Timeframe: from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days

Population: vaginal deliveries

includes vaginal deliveries only; cesarean section deliveries are excluded

Outcome measures

Measure	Oral Misoprostol n=15 Participants oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=10 Participants vaginal misoprostol given 25 mcg every 4 hours
Time to Vaginal Delivery	22.3 hours Standard Deviation 11.1	23.2 hours Standard Deviation 9.7

SECONDARY outcome

Timeframe: From enrollment until delivery, up to 3 days

Number of cesarean sections/total deliveries (%)

Outcome measures

Measure	Oral Misoprostol n=17 Participants oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=17 Participants vaginal misoprostol given 25 mcg every 4 hours
Cesarean Section Rate	2 Participants	7 Participants

SECONDARY outcome

Timeframe: from enrollment until delivery, up to 3 days

Tachysystole is defined as 4 or more contractions in a 10 minute period.

Outcome measures

Measure	Oral Misoprostol n=17 Participants oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=17 Participants vaginal misoprostol given 25 mcg every 4 hours
Rate of Tachysystole	1 Participants	4 Participants

SECONDARY outcome

Timeframe: From enrollment until delivery, up to 3 days

Previously defined as "hyperstimulation", this outcome measure is defined as 4 or more contractions in a 10 minute period (tachysystole) thought to be causing recurrent variable or late decelerations, bradycardia, or minimal variability in the fetal heart rate tracing (non-reassuring fetal heart tones,which would require intervention to resolve or delivery of the infant).

Outcome measures

Measure	Oral Misoprostol n=17 Participants oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=17 Participants vaginal misoprostol given 25 mcg every 4 hours
Rate of Tachysystole Causing Non-reassuring Fetal Heart Tones	1 Participants	2 Participants

SECONDARY outcome

Timeframe: from enrollment until delivery, up to 3 days

Tocolysis is the administration of medication to decrease or stop contractions.

Outcome measures

Measure	Oral Misoprostol n=17 Participants oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=16 Participants vaginal misoprostol given 25 mcg every 4 hours
Rate of Need for Tocolysis	1 Participants	2 Participants

SECONDARY outcome

Timeframe: from enrollment until delivery, up to 3 days

Chorioamnionitis is defined as an intraamniotic infection.

Outcome measures

Measure	Oral Misoprostol n=17 Participants oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=17 Participants vaginal misoprostol given 25 mcg every 4 hours
Rate of Chorioamnionitis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from enrollment until delivery, up to 3 days

Amniotic fluid with visible meconium (from fetal defecation) within it.

Outcome measures

Measure	Oral Misoprostol n=17 Participants oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=16 Participants vaginal misoprostol given 25 mcg every 4 hours
Rate of Meconium Stained Fluid	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 4 hours from delivery

Population: Excludes neonates with APGAR score\>7 not admitted to NICU but were missing cord blood gas results

binary composite outcome defined as Apgar score < 7, or cord blood gas pH of less than 7 or base deficit great than 12, or neonatal intensive care unit admission within 4 hours of delivery.

Outcome measures

Measure	Oral Misoprostol n=10 Participants oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=12 Participants vaginal misoprostol given 25 mcg every 4 hours
Neonatal Morbidity	2 Participants	3 Participants

SECONDARY outcome

Timeframe: from enrollment until delivery, up to 3 days

Use of medication to treat nausea.

Outcome measures

Measure	Oral Misoprostol n=17 Participants oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=17 Participants vaginal misoprostol given 25 mcg every 4 hours
Rate of Anti-emetic Use	7 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 hours from start of induction of labor (first misoprostol administration)

Population: vaginal deliveries only

Vaginal delivery within from start of induction with misoprostol.

Outcome measures

Measure	Oral Misoprostol n=15 Participants oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=10 Participants vaginal misoprostol given 25 mcg every 4 hours
Rate of Vaginal Delivery Within 24 Hours	10 Participants	6 Participants

SECONDARY outcome

Timeframe: from enrollment until delivery, up to 3 days

Based on clinician's judgment on the progress of the induction, the rate that misoprostol administration was stopped and a cervical ripening balloon was used instead

Outcome measures

Measure	Oral Misoprostol n=17 Participants oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=17 Participants vaginal misoprostol given 25 mcg every 4 hours
Rate of Abandoning Misoprostol for Cervical Ripening and Switching to Mechanical Dilation for Cervical Ripening	2 Participants	7 Participants

Adverse Events

Oral Misoprostol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Vaginal Misoprostol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oral Misoprostol n=17 participants at risk oral misoprostol given 25 mcg every 2 hours	Vaginal Misoprostol n=17 participants at risk vaginal misoprostol given 25 mcg every 4 hours
Pregnancy, puerperium and perinatal conditions Neonatal NICU admission	5.9% 1/17 • Number of events 1 • During hospital stay-admission for induction until discharge after delivery, up to 7 days. Charts were reviewed for the specific events of postpartum hemorrhage requiring blood transfusion, maternal surgical ICU admission and neonatal NICU admission during the maternal hospital stay (admission for induction until discharge after delivery, up to 7 days).	5.9% 1/17 • Number of events 1 • During hospital stay-admission for induction until discharge after delivery, up to 7 days. Charts were reviewed for the specific events of postpartum hemorrhage requiring blood transfusion, maternal surgical ICU admission and neonatal NICU admission during the maternal hospital stay (admission for induction until discharge after delivery, up to 7 days).

Additional Information

Dr. Jaimey Pauli

Penn State Milton S. Hershey Medical Center

Phone: 717-531-8142

Email: jpauli@pennstatehealth.psu.edu

Results disclosure agreements

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