Trial Outcomes & Findings for Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor (NCT NCT00308711)

NCT ID: NCT00308711

Last Updated: 2012-06-25

Results Overview

Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1308 participants
• Primary outcome timeframe: 2880 minutes
• Results posted on: 2012-06-25

Participant Flow

First subject entered 26 April 2006; last subject completed 07 August 2007; 49 hospitals entered subjects requiring cervical ripening prior to induction of labor.

Participant milestones

Measure	Misoprostol Vaginal Insert (MVI) 100 Misoprostol vaginal insert 100 mcg over a period of up to 24 h	Misoprostol Vaginal Insert (MVI) 50 Misoprostol vaginal insert 50 mcg over a period of up to 24 h	Cervidil 10 mg Vaginal Insert Cervidil 10 mg vaginal insert over a period of up to 24h
Overall Study STARTED	428	444	436
Overall Study COMPLETED	426	440	431
Overall Study NOT COMPLETED	2	4	5

Reasons for withdrawal

Measure	Misoprostol Vaginal Insert (MVI) 100 Misoprostol vaginal insert 100 mcg over a period of up to 24 h	Misoprostol Vaginal Insert (MVI) 50 Misoprostol vaginal insert 50 mcg over a period of up to 24 h	Cervidil 10 mg Vaginal Insert Cervidil 10 mg vaginal insert over a period of up to 24h
Overall Study Withdrawal by Subject	1	0	1
Overall Study Protocol Violation	0	1	1
Overall Study Lost to Follow-up	0	1	0
Overall Study Baby not born within 7 days of treatment	1	2	2
Overall Study Subject incarcerated, data not allowed	0	0	1

Baseline Characteristics

Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor

Baseline characteristics by cohort

Measure	Misoprostol Vaginal Insert (MVI) 100 n=428 Participants Misoprostol vaginal insert 100 mcg over a period of up to 24 h	Misoprostol Vaginal Insert (MVI) 50 n=444 Participants Misoprostol vaginal insert 50 mcg over a period of up to 24 h	Cervidil 10 mg Vaginal Insert n=436 Participants Cervidil 10 mg vaginal insert over a period of up to 24h	Total n=1308 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	428 Participants n=5 Participants	444 Participants n=7 Participants	436 Participants n=5 Participants	1308 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	26.2 years STANDARD_DEVIATION 5.9 • n=5 Participants	26.9 years STANDARD_DEVIATION 6.2 • n=7 Participants	26.0 years STANDARD_DEVIATION 5.7 • n=5 Participants	26.4 years STANDARD_DEVIATION 5.9 • n=4 Participants
Sex: Female, Male Female	428 Participants n=5 Participants	444 Participants n=7 Participants	436 Participants n=5 Participants	1308 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	413 participants n=5 Participants	427 participants n=7 Participants	419 participants n=5 Participants	1259 participants n=4 Participants
Region of Enrollment Canada	15 participants n=5 Participants	17 participants n=7 Participants	17 participants n=5 Participants	49 participants n=4 Participants
Parity Nulliparous	267 participants n=5 Participants	275 participants n=7 Participants	270 participants n=5 Participants	812 participants n=4 Participants
Parity Parous	161 participants n=5 Participants	169 participants n=7 Participants	166 participants n=5 Participants	496 participants n=4 Participants
modified Bishop score (mBS)	2.69 Units on a scale of 0 (low) to 12 (most) STANDARD_DEVIATION 1.1 • n=5 Participants	2.74 Units on a scale of 0 (low) to 12 (most) STANDARD_DEVIATION 1.1 • n=7 Participants	2.73 Units on a scale of 0 (low) to 12 (most) STANDARD_DEVIATION 1.1 • n=5 Participants	2.72 Units on a scale of 0 (low) to 12 (most) STANDARD_DEVIATION 1.1 • n=4 Participants

PRIMARY outcome

Timeframe: 2880 minutes

Population: This analysis is for time to vaginal delivery (interval from insertion of study drug into the vagina to the delivery of the neonate); patients delivered by cesarean section were censored from this time-to-event analysis using the longest interval for all participants from insertion of study drug to cesarean section delivery of neonate.

Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered.

Outcome measures

Measure	Misoprostol Vaginal Insert (MVI) 100 n=426 Participants Misoprostol vaginal insert 100 mcg over a period of up to 24 h	Misoprostol Vaginal Insert (MVI) 50 n=440 Participants Misoprostol vaginal insert 50 mcg over a period of up to 24 h	Cervidil 10 mg Vaginal Insert n=431 Participants Cervidil 10 mg vaginal insert over a period of up to 24h
Minutes From Drug Insertion to Vaginal Delivery	1595.5 minutes Interval 1469.0 to 1739.0	2127 minutes Interval 1977.0 to 2253.0	1649.5 minutes Interval 1509.0 to 1824.0

PRIMARY outcome

Timeframe: 2880 minutes

Percentage of participants with cesarean delivery after study drug was administered. There is no set assessment time or date as the woman's labor may last hours or days.

Outcome measures

Measure	Misoprostol Vaginal Insert (MVI) 100 n=426 Participants Misoprostol vaginal insert 100 mcg over a period of up to 24 h	Misoprostol Vaginal Insert (MVI) 50 n=440 Participants Misoprostol vaginal insert 50 mcg over a period of up to 24 h	Cervidil 10 mg Vaginal Insert n=431 Participants Cervidil 10 mg vaginal insert over a period of up to 24h
Percentage of Participants With a Cesarean Section Delivery	28 Percentage of participants Interval 23.6 to 32.3	28 Percentage of participants Interval 23.9 to 32.4	26 Percentage of participants Interval 22.3 to 30.8

SECONDARY outcome

Timeframe: 96 hours

Population: Analysis was based on intention to treat, i.e., all subjects who had the insert placed in the vagina.

This outcome reports the percentage of adverse events in each treatment arm spontaneously reported or observed during the study. The intrapartum period (mother is still pregnant) is called the "Maternal/Fetal" period; once the baby has been born, adverse events are assessed separately for the mother (Post Partum) and the baby (Neonatal). The number of adverse events was assessed separately for each of the three periods.

Outcome measures

Measure	Misoprostol Vaginal Insert (MVI) 100 n=426 Participants Misoprostol vaginal insert 100 mcg over a period of up to 24 h	Misoprostol Vaginal Insert (MVI) 50 n=440 Participants Misoprostol vaginal insert 50 mcg over a period of up to 24 h	Cervidil 10 mg Vaginal Insert n=431 Participants Cervidil 10 mg vaginal insert over a period of up to 24h
Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events Maternal/Fetal	65 Percentage of participants	64 Percentage of participants	65 Percentage of participants
Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events Maternal (Post-Partum)	29 Percentage of participants	26 Percentage of participants	27 Percentage of participants
Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events Neonatal	29 Percentage of participants	24 Percentage of participants	27 Percentage of participants

SECONDARY outcome

Timeframe: 2880 minutes

Population: This analysis included all participants exposed to study drug and for whom there was data available regarding whether oxytocin was used pre-delivery.

Incidence in each treatment group of need for oxytocin for pre-delivery induction or augmentation of labor.

Outcome measures

Measure	Misoprostol Vaginal Insert (MVI) 100 n=426 Participants Misoprostol vaginal insert 100 mcg over a period of up to 24 h	Misoprostol Vaginal Insert (MVI) 50 n=440 Participants Misoprostol vaginal insert 50 mcg over a period of up to 24 h	Cervidil 10 mg Vaginal Insert n=431 Participants Cervidil 10 mg vaginal insert over a period of up to 24h
Percentage of Participants With Pre-Delivery Oxytocin Use	68.5 Percentage of participants	80.8 Percentage of participants	69.0 Percentage of participants

SECONDARY outcome

Timeframe: 12 hours

Measured the percentage of participants who achieved success on the mBS. This composite score is based on the mBS and vaginal delivery and it is measured 12 hours after insertion of the study drug. The mBS has a score of 0 when the cervix is not ripe and a score of 12 when completely ripened. The 12 hour score is compared to baseline. Using the mBS, assess at 12 hours whether each subject has met any of the following three criteria: 1) has improved (increased) the mBS by at least 3 points from baseline; 2) has reached a score of at least 6 on the mBS; or 3) has acheived a vaginal delivery.

Outcome measures

Measure	Misoprostol Vaginal Insert (MVI) 100 n=426 Participants Misoprostol vaginal insert 100 mcg over a period of up to 24 h	Misoprostol Vaginal Insert (MVI) 50 n=440 Participants Misoprostol vaginal insert 50 mcg over a period of up to 24 h	Cervidil 10 mg Vaginal Insert n=431 Participants Cervidil 10 mg vaginal insert over a period of up to 24h
Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert	59 Percentage of Participants 3.15	50 Percentage of Participants 2.8	60 Percentage of Participants 3.3

SECONDARY outcome

Timeframe: 2880 minutes

Interval from insertion of study drug to onset of active labor, defined as at least three contractions in a ten-minute period of at least moderate intensity and resulting in cervical change such as dilatation or effacement; OR at least 4 cm cervical dilatation achieved after progressive change in dilatation.

Outcome measures

Measure	Misoprostol Vaginal Insert (MVI) 100 n=426 Participants Misoprostol vaginal insert 100 mcg over a period of up to 24 h	Misoprostol Vaginal Insert (MVI) 50 n=440 Participants Misoprostol vaginal insert 50 mcg over a period of up to 24 h	Cervidil 10 mg Vaginal Insert n=431 Participants Cervidil 10 mg vaginal insert over a period of up to 24h
Minutes to Onset of Active Labor	1032.5 minutes Standard Deviation 627.2	1343.7 minutes Standard Deviation 692.0	1005.2 minutes Standard Deviation 667.1

SECONDARY outcome

Timeframe: 2880 minutes

Interval from study drug insertion to ROM.

Outcome measures

Measure	Misoprostol Vaginal Insert (MVI) 100 n=426 Participants Misoprostol vaginal insert 100 mcg over a period of up to 24 h	Misoprostol Vaginal Insert (MVI) 50 n=440 Participants Misoprostol vaginal insert 50 mcg over a period of up to 24 h	Cervidil 10 mg Vaginal Insert n=431 Participants Cervidil 10 mg vaginal insert over a period of up to 24h
Minutes to Rupture of Membranes (ROM)	1285.0 minutes Interval 906.0 to 2208.0	1364.0 minutes Interval 1048.0 to 2491.0	1123 minutes Interval 915.0 to 1580.0

SECONDARY outcome

Timeframe: 5760 minuts

Minutes in Labor and Delivery (L & D) suite starting from insertion of the study drug to discharge from L & D to post partum care.

Outcome measures

Measure	Misoprostol Vaginal Insert (MVI) 100 n=426 Participants Misoprostol vaginal insert 100 mcg over a period of up to 24 h	Misoprostol Vaginal Insert (MVI) 50 n=440 Participants Misoprostol vaginal insert 50 mcg over a period of up to 24 h	Cervidil 10 mg Vaginal Insert n=431 Participants Cervidil 10 mg vaginal insert over a period of up to 24h
Duration of Stay in Minutes in Labor and Delivery Suite	1683.6 minutes Standard Deviation 811	2010 minutes Standard Deviation 850	1729 minutes Standard Deviation 862

SECONDARY outcome

Timeframe: 10 days

Duration of stay in hospital for mother and neonate starting with insertion of the study drug and ending with discharge from the hospital.

Outcome measures

Measure	Misoprostol Vaginal Insert (MVI) 100 n=426 Participants Misoprostol vaginal insert 100 mcg over a period of up to 24 h	Misoprostol Vaginal Insert (MVI) 50 n=440 Participants Misoprostol vaginal insert 50 mcg over a period of up to 24 h	Cervidil 10 mg Vaginal Insert n=431 Participants Cervidil 10 mg vaginal insert over a period of up to 24h
Days in Hospital for Mother and Neonate Mother	4.5 days Standard Deviation 1.24	4.7 days Standard Deviation 1.1	4.5 days Standard Deviation 1.3
Days in Hospital for Mother and Neonate Neonate	3.6 days Standard Deviation 1.8	3.5 days Standard Deviation 1.2	3.6 days Standard Deviation 1.6

Adverse Events

Misoprostol Vaginal Insert (MVI) 100

Serious events: 106 serious events

Other events: 130 other events

Deaths: 0 deaths

Misoprostol Vaginal Insert (MVI) 50

Serious events: 134 serious events

Other events: 129 other events

Deaths: 0 deaths

Cervidil 10 mg Vaginal Insert

Serious events: 117 serious events

Other events: 132 other events

Deaths: 0 deaths

Serious adverse events

Measure	Misoprostol Vaginal Insert (MVI) 100 n=428 participants at risk Misoprostol vaginal insert 100 mcg over a period of up to 24 h	Misoprostol Vaginal Insert (MVI) 50 n=443 participants at risk Misoprostol vaginal insert 50 mcg over a period of up to 24 h	Cervidil 10 mg Vaginal Insert n=436 participants at risk Cervidil 10 mg vaginal insert over a period of up to 24h
Infections and infestations cellulitis	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Infections and infestations pyelonephritis	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.46% 2/436 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions Arrested Labor	5.8% 25/428 • Number of events 25 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	8.1% 36/443 • Number of events 36 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	7.6% 33/436 • Number of events 33 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions Cephalopelvic Disproportion	3.3% 14/428 • Number of events 14 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	7.9% 35/443 • Number of events 35 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	6.7% 29/436 • Number of events 29 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Blood and lymphatic system disorders Thrombocytopenia	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Cardiac disorders Wolff-Parkinson-White Syndrome	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/443 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Infections and infestations Herpes Simplex	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions Abnormal Labor Affecting Fetus	0.47% 2/428 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions Chorioamnionitis	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.90% 4/443 • Number of events 4 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions Foetal heart rate disorder	10.7% 46/428 • Number of events 46 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	10.6% 47/443 • Number of events 47 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	8.0% 35/436 • Number of events 35 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions Foetal malpresentation	0.93% 4/428 • Number of events 4 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.68% 3/443 • Number of events 3 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	1.4% 6/436 • Number of events 6 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions Pregnancy-induced hypertension	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions Premature separation of placenta	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions umbilical cord prolapse	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	1.1% 5/436 • Number of events 5 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions uterine contractions abnormal	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/443 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions uterine hypertonus	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/443 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Blood and lymphatic system disorders Anaemia	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/443 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Cardiac disorders Cardiac Failure Congestive	0.70% 3/428 • Number of events 3 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.45% 2/443 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Cardiac disorders congestive cardiomyopathy	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Cardiac disorders Tachycardia	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Gastrointestinal disorders Ileus	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Cardiac disorders Chest pain	0.47% 2/428 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
General disorders Pyrexia	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Hepatobiliary disorders Liver abscess	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/443 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Infections and infestations Endometritis	0.47% 2/428 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.45% 2/443 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.69% 3/436 • Number of events 3 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Infections and infestations wound infection	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Investigations urine output decreased	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Nervous system disorders peroneal nerve palsy	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions postpartum hemorrhage	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.90% 4/443 • Number of events 4 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.92% 4/436 • Number of events 4 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions preeclampsia	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Renal and urinary disorders nephrolithiasis	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.46% 2/436 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Renal and urinary disorders urinary retention	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Reproductive system and breast disorders uterine atony	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Respiratory, thoracic and mediastinal disorders dyspnoea	0.47% 2/428 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.45% 2/443 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Respiratory, thoracic and mediastinal disorders pleuritic pain	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/443 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Vascular disorders hypertension	0.47% 2/428 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Blood and lymphatic system disorders polycythaemia	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Cardiac disorders bradycardia neonatal	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Cardiac disorders tachcardia foetal	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Congenital, familial and genetic disorders congenital anomaly	2.3% 10/428 • Number of events 10 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	1.6% 7/443 • Number of events 7 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	1.6% 7/436 • Number of events 7 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
General disorders Neonatal hypothermia	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/443 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Hepatobiliary disorders hyperbilirubinemia neonatal	1.4% 6/428 • Number of events 6 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	1.1% 5/443 • Number of events 5 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	1.8% 8/436 • Number of events 8 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Infections and infestations Group B sepsis neonatal	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Infections and infestations sepsis	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/443 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Investigations Apgar score low	0.93% 4/428 • Number of events 4 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.45% 2/443 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.46% 2/436 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions ABO hemolytic disease of the newborn	2.1% 9/428 • Number of events 9 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	1.8% 8/443 • Number of events 9 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.69% 3/436 • Number of events 3 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions cephalohaematoma	0.00% 0/428 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/443 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.00% 0/436 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions jaundice	0.47% 2/428 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.45% 2/443 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/436 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Respiratory, thoracic and mediastinal disorders neonatal aspiration	0.47% 2/428 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/443 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.92% 4/436 • Number of events 4 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Respiratory, thoracic and mediastinal disorders neonatal respiratory depression	1.2% 5/428 • Number of events 5 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/443 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	1.1% 5/436 • Number of events 5 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Respiratory, thoracic and mediastinal disorders neonatal respiratory distress syndrome	0.47% 2/428 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.68% 3/443 • Number of events 3 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.92% 4/436 • Number of events 4 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Respiratory, thoracic and mediastinal disorders transient tachypnea of the newborn	0.23% 1/428 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.23% 1/443 • Number of events 1 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.92% 4/436 • Number of events 4 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Surgical and medical procedures infection prophylaxis	0.47% 2/428 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.68% 3/443 • Number of events 3 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	0.46% 2/436 • Number of events 2 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.

Other adverse events

Measure	Misoprostol Vaginal Insert (MVI) 100 n=428 participants at risk Misoprostol vaginal insert 100 mcg over a period of up to 24 h	Misoprostol Vaginal Insert (MVI) 50 n=443 participants at risk Misoprostol vaginal insert 50 mcg over a period of up to 24 h	Cervidil 10 mg Vaginal Insert n=436 participants at risk Cervidil 10 mg vaginal insert over a period of up to 24h
Pregnancy, puerperium and perinatal conditions Abnormal labour affecting foetus	5.6% 24/428 • Number of events 24 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	2.7% 12/443 • Number of events 12 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	6.4% 28/436 • Number of events 28 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions Chorioamnionitis	4.0% 17/428 • Number of events 17 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	6.8% 30/443 • Number of events 30 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	5.0% 22/436 • Number of events 22 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions Foetal heart rate disorder	30.4% 130/428 • Number of events 130 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	29.1% 129/443 • Number of events 129 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	30.3% 132/436 • Number of events 132 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions Meconium in amniotic fluid	8.9% 38/428 • Number of events 38 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	10.2% 45/443 • Number of events 45 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	10.1% 44/436 • Number of events 44 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions uterine contractions abnormal	19.4% 83/428 • Number of events 86 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	13.8% 61/443 • Number of events 63 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	18.6% 81/436 • Number of events 89 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions uterine hypertonus	4.0% 17/428 • Number of events 17 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	3.6% 16/443 • Number of events 16 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	5.7% 25/436 • Number of events 25 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Vascular disorders Hypotension	4.2% 18/428 • Number of events 18 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	4.7% 21/443 • Number of events 21 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	5.3% 23/436 • Number of events 23 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Blood and lymphatic system disorders Anemia	4.9% 21/428 • Number of events 21 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	5.6% 25/443 • Number of events 25 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	4.6% 20/436 • Number of events 20 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions Perineal laceration	4.9% 21/428 • Number of events 21 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	6.3% 28/443 • Number of events 28 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	4.8% 21/436 • Number of events 21 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Pregnancy, puerperium and perinatal conditions post partum hemorrhage	4.0% 17/428 • Number of events 17 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	3.6% 16/443 • Number of events 16 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	4.8% 21/436 • Number of events 21 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Hepatobiliary disorders neonatal hyperbilirubinemia	2.1% 9/428 • Number of events 9 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	1.4% 6/443 • Number of events 6 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	3.4% 15/436 • Number of events 15 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
Investigations Apgar score low	2.3% 10/428 • Number of events 10 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	2.3% 10/443 • Number of events 10 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.	2.3% 10/436 • Number of events 10 • 96 hours Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.

Additional Information

Barbara L. Powers

Cytokine PharmaSciences, Inc.

Phone: 610-687-1776

Email: bpowers@cytokinepharmasciences.com

Results disclosure agreements

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