Trial Outcomes & Findings for A Study Comparing Vaginal Misoprostol and Intravenous Oxytocin for Induction of Labor (NCT NCT01634854)

NCT ID: NCT01634854

Last Updated: 2017-12-19

Results Overview

Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 130 participants
• Primary outcome timeframe: Time to delivery in minutes from initiation of medication, up to 24 hours
• Results posted on: 2017-12-19

Participant Flow

Participant milestones

Measure	Vaginal Misoprostol Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal	Intravenous Oxytocin 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous
Overall Study STARTED	64	66
Overall Study COMPLETED	62	59
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Measure	Vaginal Misoprostol Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal	Intravenous Oxytocin 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous
Overall Study Cesarean delivery	2	7

Baseline Characteristics

A Study Comparing Vaginal Misoprostol and Intravenous Oxytocin for Induction of Labor

Baseline characteristics by cohort

Measure	Vaginal Misoprostol n=62 Participants Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal	Intravenous Oxytocin n=59 Participants 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous	Total n=121 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	62 Participants n=5 Participants	59 Participants n=7 Participants	121 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	59 Participants n=7 Participants	121 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	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants	55 Participants n=7 Participants	111 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	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	46 Participants n=7 Participants	89 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	62 Participants n=5 Participants	59 Participants n=7 Participants	121 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time to delivery in minutes from initiation of medication, up to 24 hours

Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin.

Outcome measures

Measure	Vaginal Misoprostol n=62 Participants Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal	Intravenous Oxytocin n=59 Participants 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous
Time From Induction to Vaginal Delivery	800 minutes Interval 516.0 to 1107.0	693 minutes Interval 481.0 to 884.0

SECONDARY outcome

Timeframe: At 1 minute and 5 minutes after delivery

APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low.

Outcome measures

Measure	Vaginal Misoprostol n=62 Participants Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal	Intravenous Oxytocin n=59 Participants 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous
Neonatal APGAR Scores APGAR 1 minute	8 number Interval 8.0 to 8.0	8 number Interval 8.0 to 8.0
Neonatal APGAR Scores APGAR 5 minute	9 number Interval 9.0 to 9.0	9 number Interval 9.0 to 9.0

SECONDARY outcome

Timeframe: Immediately following delivery

Neonatal Weight

Outcome measures

Measure	Vaginal Misoprostol n=62 Participants Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal	Intravenous Oxytocin n=59 Participants 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous
Neonatal Weight at Delivery	3500 grams Interval 3082.0 to 3849.0	3415 grams Interval 3182.0 to 3792.0

SECONDARY outcome

Timeframe: Through discharge from hospital

Maternal delivery outcomes

Outcome measures

Measure	Vaginal Misoprostol n=62 Participants Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal	Intravenous Oxytocin n=59 Participants 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous
Maternal Delivery Outcomes Epidural	56 Participants	48 Participants
Maternal Delivery Outcomes Hemorrhage	2 Participants	3 Participants
Maternal Delivery Outcomes Chorioamnionitis	2 Participants	0 Participants
Maternal Delivery Outcomes Cesarean delivery	2 Participants	7 Participants
Maternal Delivery Outcomes Forceps delivery	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 weeks post-partum

Population: data was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured from initiation of medication until delivery time

Number of patients receiving terbutaline during labor for uterine tachysytole

Outcome measures

Measure	Vaginal Misoprostol n=62 Participants Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal	Intravenous Oxytocin n=59 Participants 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous
Number of Participants With Excessive Uterine Activity Necessitating Treatment	9 Participants	4 Participants

SECONDARY outcome

Timeframe: Through discharge from hospital

NICU admission and APGAR less than 7 at 5 minutes

Outcome measures

Measure	Vaginal Misoprostol n=62 Participants Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal	Intravenous Oxytocin n=59 Participants 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous
NICU Admission and APGAR Less Than 7 at 5 Minutes NICU Admission	8 Participants	4 Participants
NICU Admission and APGAR Less Than 7 at 5 Minutes APGAR less than 7 at 5 min	0 Participants	0 Participants

Adverse Events

Vaginal Misoprostol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravenous Oxytocin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Angela Wilson-Liverman CNM

Vanderbilt University Medical Center

Email: angela.wilson-liverman@vanderbilt.edu

Results disclosure agreements

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