Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject entered 26 April 2006; last subject completed 07 August 2007; 49 hospitals entered subjects requiring cervical ripening prior to induction of labor.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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

Participant Flow:   Overall Study

	Misoprostol Vaginal Insert (MVI) 100	Misoprostol Vaginal Insert (MVI) 50	Cervidil 10 mg Vaginal Insert
STARTED	428	444	436
COMPLETED	426	440	431
NOT COMPLETED	2	4	5
Withdrawal by Subject	1	0	1
Protocol Violation	0	1	1
Lost to Follow-up	0	1	0
Baby not born within 7 days of treatment	1	2	2
Subject incarcerated, data not allowed	0	0	1

Reporting Groups

	Description
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

Baseline Measures

	Misoprostol Vaginal Insert (MVI) 100	Misoprostol Vaginal Insert (MVI) 50	Cervidil 10 mg Vaginal Insert	Total
Number of Participants   [units: participants]	428	444	436	1308
Age   [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	428	444	436	1308
>=65 years	0	0	0	0
Age   [units: years] Mean ± Standard Deviation	26.2  ± 5.9	26.9  ± 6.2	26.0  ± 5.7	26.4  ± 5.9
Gender   [units: participants]
Female	428	444	436	1308
Male	0	0	0	0
Region of Enrollment   [units: participants]
United States	413	427	419	1259
Canada	15	17	17	49
Parity [1] [units: participants]
Nulliparous	267	275	270	812
Parous	161	169	166	496
modified Bishop score (mBS) [2] [units: Units on a scale of 0 (low) to 12 (most)] Mean ± Standard Deviation	2.69  ± 1.1	2.74  ± 1.1	2.73  ± 1.1	2.72  ± 1.1

1.  Primary:

Minutes From Drug Insertion to Vaginal Delivery   [ Time Frame: 2880 minutes ]

2.  Primary:

Percentage of Participants With a Cesarean Section Delivery   [ Time Frame: 2880 minutes ]

3.  Secondary:

Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events   [ Time Frame: 96 hours ]

4.  Secondary:

Percentage of Participants With Pre-Delivery Oxytocin Use   [ Time Frame: 2880 minutes ]

5.  Secondary:

Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert   [ Time Frame: 12 hours ]

6.  Secondary:

Minutes to Onset of Active Labor   [ Time Frame: 2880 minutes ]

7.  Secondary:

Minutes to Rupture of Membranes (ROM)   [ Time Frame: 2880 minutes ]

8.  Secondary:

Duration of Stay in Minutes in Labor and Delivery Suite   [ Time Frame: 5760 minuts ]

9.  Secondary:

Days in Hospital for Mother and Neonate   [ Time Frame: 10 days ]