Trial Outcomes & Findings for Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor (NCT NCT00828711)

NCT ID: NCT00828711

Last Updated: 2014-04-21

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

374 participants

Primary outcome timeframe

Interval from study drug administration to 24 hours

Results posted on

2014-04-21

Participant Flow

Pregnant women who required to be induced were recruited at 11 sites in the US

Participant milestones

Participant milestones
Measure	MVI 100 MVI 100 mcg vaginal insert Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 150 MVI 150 mcg vaginal insert Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 200 MVI 200 mcg vaginal insert Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Overall Study STARTED	118	125	131
Overall Study COMPLETED	117	125	131
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	MVI 100 MVI 100 mcg vaginal insert Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 150 MVI 150 mcg vaginal insert Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 200 MVI 200 mcg vaginal insert Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Overall Study Lost to Follow-up	1	0	0

Baseline Characteristics

Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MVI 100 n=117 Participants MVI 100 mcg vaginal insert Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 150 n=125 Participants MVI 150 mcg vaginal insert Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 200 n=131 Participants MVI 200 mcg vaginal insert Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	Total n=373 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	117 Participants n=5 Participants	125 Participants n=7 Participants	131 Participants n=5 Participants	373 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	26.0 years STANDARD_DEVIATION 6.24 • n=5 Participants	25.8 years STANDARD_DEVIATION 5.92 • n=7 Participants	25.5 years STANDARD_DEVIATION 5.93 • n=5 Participants	25.8 years STANDARD_DEVIATION 6.01 • n=4 Participants
Sex: Female, Male Female	117 Participants n=5 Participants	125 Participants n=7 Participants	131 Participants n=5 Participants	373 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	117 participants n=5 Participants	125 participants n=7 Participants	131 participants n=5 Participants	373 participants n=4 Participants

PRIMARY outcome

Timeframe: Interval from study drug administration to 24 hours

Population: Analysis based on Modified Intention-to-Treat (MITT) population who delivered vaginally. Percentage of subjects who delivered vaginally is presented.

Outcome measures

Outcome measures
Measure	MVI 100 n=80 Participants MVI 100 mcg vaginal insert Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 150 n=87 Participants MVI 150 mcg vaginal insert Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 200 n=100 Participants MVI 200 mcg vaginal insert Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Proportion of Women Delivering Vaginally	63.75 percentage of participants Interval 52.24 to 74.21	66.67 percentage of participants Interval 55.75 to 76.42	76.00 percentage of participants Interval 66.43 to 83.98

SECONDARY outcome

Timeframe: Interval from study drug administration to delivery (average 24 hours)

Population: Kaplan-Meier Estimates are based on Modified Intention-to-Treat (MITT) population.Subjects who had a cesarean, discharged prior to delivery or withdrew consent during first hospitalization were censored (MVI 100: 37, MVI 150: 39, MVI 200: 31) using the longest time interval from study drug administration to cesarean or to Labor \& Delivery discharge

Outcome measures

Outcome measures
Measure	MVI 100 n=117 Participants MVI 100 mcg vaginal insert Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 150 n=125 Participants MVI 150 mcg vaginal insert Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 200 n=131 Participants MVI 200 mcg vaginal insert Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Time to Vaginal Delivery	1744 minutes Interval 1368.0 to 2198.0	1535 minutes Interval 1292.0 to 2063.0	1181 minutes Interval 1035.0 to 1443.0

SECONDARY outcome

Timeframe: From study drug administration to hospital discharge (approximately 48 - 72 hours)

Population: The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.

All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.

Outcome measures

Outcome measures
Measure	MVI 100 n=118 Participants MVI 100 mcg vaginal insert Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 150 n=125 Participants MVI 150 mcg vaginal insert Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 200 n=131 Participants MVI 200 mcg vaginal insert Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Rate of Adverse Events Subjects with Intrapartum Adverse Events	81.4 percentage of participants	80.0 percentage of participants	79.4 percentage of participants
Rate of Adverse Events Subjects with Maternal Postpartum Adverse Events	28.0 percentage of participants	27.2 percentage of participants	32.1 percentage of participants
Rate of Adverse Events Subjects with Neonatal Adverse Events	39.8 percentage of participants	42.4 percentage of participants	48.9 percentage of participants

SECONDARY outcome

Timeframe: Interval from study drug administration to cesarean delivery (average 24 hours)

Population: Percentage of subjects who had a cesarean delivery during the first hospitalization (safety population) is presented.

Outcome measures

Outcome measures
Measure	MVI 100 n=118 Participants MVI 100 mcg vaginal insert Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 150 n=125 Participants MVI 150 mcg vaginal insert Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 200 n=131 Participants MVI 200 mcg vaginal insert Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Proportion of Cesarean Delivery	31.36 percentage of participants Interval 23.13 to 40.54	30.40 percentage of participants Interval 22.49 to 39.26	22.90 percentage of participants Interval 16.02 to 31.05

SECONDARY outcome

Timeframe: 12 hours after insertion of drug

Population: Percentage of subjects with cervical ripening success at 12 hours is presented (Modified Intention-to-Treat population).

Cervical ripening success was defined by achievement of one or more of the following by 12 hours after study drug administration: * Increase from baseline in modified Bishop score ≥3; or * Achievement of modified Bishop score of ≥6; or * Vaginal delivery.

Outcome measures

Outcome measures
Measure	MVI 100 n=117 Participants MVI 100 mcg vaginal insert Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 150 n=125 Participants MVI 150 mcg vaginal insert Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 200 n=131 Participants MVI 200 mcg vaginal insert Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Cervical Ripening Using Composite Measure of Success	77.78 percentage of participants Interval 69.16 to 84.94	77.60 percentage of participants Interval 69.28 to 84.57	80.15 percentage of participants Interval 72.29 to 86.61

SECONDARY outcome

Timeframe: At least 30 minutes after study drug removal

Population: Percentage of subjects who required pre-delivery oxytocin is presented (Modified Intention-to-Treat population).

Percentage of participants in receipt of Oxytocin for induction after study drug removal is accurate and appropriate for this outcome measure.

Outcome measures

Outcome measures
Measure	MVI 100 n=117 Participants MVI 100 mcg vaginal insert Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 150 n=125 Participants MVI 150 mcg vaginal insert Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 200 n=131 Participants MVI 200 mcg vaginal insert Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Use of Oxytocin	70.94 percentage of participants Interval 61.83 to 78.96	60.00 percentage of participants Interval 50.86 to 68.66	48.85 percentage of participants Interval 40.03 to 57.74

SECONDARY outcome

Timeframe: From study drug insertion up to 2 hours post study drug removal

Population: The plan was to enrol 24 subjects to the pharmacokinetic (PK) arm of the study. Only 3 subjects enrolled in the PK arm; there were too few subjects and too few samples available. Due to insufficient data, no statistical analysis was possible. Only misoprostol acid levels for each blood sampling timepoint for each subject was determined.

The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5, 1 and 2 hours after removal of the study drug.

Outcome measures

Outcome measures
Measure	MVI 100 n=1 Participants MVI 100 mcg vaginal insert Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 150 n=2 Participants MVI 150 mcg vaginal insert Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 200 MVI 200 mcg vaginal insert Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid.	NA PK Parameters Only misoprostol acid levels for each blood sampling timepoint for this one subject was determined. Due to insufficient data no statistical analysis of PK parameters was possible.	NA PK Parameters Only misoprostol acid levels for each blood sampling timepoint for these two subjects were determined. Due to insufficient data no statistical analysis of PK parameters was possible.	—

SECONDARY outcome

Timeframe: Interval from study drug administration to active labor (average 12 hours)

Population: Kaplan-Meier Estimates for Time to Onset of Active Labor presented (Modified Intention-to-Treat population). Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery (Censored subjects = MVI 100: 5; MVI 150: 7; MVI 200: 8)

Outcome measures

Outcome measures
Measure	MVI 100 n=117 Participants MVI 100 mcg vaginal insert Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 150 n=125 Participants MVI 150 mcg vaginal insert Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 200 n=131 Participants MVI 200 mcg vaginal insert Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Time to Onset of Active Labor	1069.00 minutes Interval 885.0 to 1153.0	775.00 minutes Interval 724.0 to 977.0	701.00 minutes Interval 550.0 to 759.0

Adverse Events

MVI 100

Serious events: 43 serious events

Other events: 100 other events

Deaths: 0 deaths

MVI 150

Serious events: 48 serious events

Other events: 107 other events

Deaths: 0 deaths

MVI 200

Serious events: 42 serious events

Other events: 117 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	MVI 100 n=118 participants at risk MVI 100 mcg vaginal insert Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 150 n=125 participants at risk MVI 150 mcg vaginal insert Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.	MVI 200 n=131 participants at risk MVI 200 mcg vaginal insert Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Blood and lymphatic system disorders Anaemia #	8.5% 10/118 • Number of events 10 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	6.4% 8/125 • Number of events 8 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	8.4% 11/131 • Number of events 11 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.
Pregnancy, puerperium and perinatal conditions Abnormal labour affecting foetus +	6.8% 8/118 • Number of events 8 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	9.6% 12/125 • Number of events 14 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	12.2% 16/131 • Number of events 16 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.
Pregnancy, puerperium and perinatal conditions Caput succedaneum *	3.4% 4/118 • Number of events 4 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	4.0% 5/125 • Number of events 5 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	5.3% 7/131 • Number of events 7 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.
Pregnancy, puerperium and perinatal conditions Chorioamnionitis +	4.2% 5/118 • Number of events 5 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	5.6% 7/125 • Number of events 7 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	1.5% 2/131 • Number of events 2 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.
Pregnancy, puerperium and perinatal conditions Foetal heart rate disorder +	56.8% 67/118 • Number of events 96 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	49.6% 62/125 • Number of events 79 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	43.5% 57/131 • Number of events 87 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.
Pregnancy, puerperium and perinatal conditions Hyperbilirubinaemia neonatal *	7.6% 9/118 • Number of events 9 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	4.8% 6/125 • Number of events 6 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	7.6% 10/131 • Number of events 10 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.
Pregnancy, puerperium and perinatal conditions Meconium in amniotic fluid +	12.7% 15/118 • Number of events 15 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	10.4% 13/125 • Number of events 13 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	16.8% 22/131 • Number of events 22 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage #	3.4% 4/118 • Number of events 4 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	4.0% 5/125 • Number of events 5 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	6.1% 8/131 • Number of events 8 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.
Pregnancy, puerperium and perinatal conditions Umbilical cord around neck *	11.9% 14/118 • Number of events 14 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	8.8% 11/125 • Number of events 11 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	16.8% 22/131 • Number of events 22 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.
Pregnancy, puerperium and perinatal conditions Uterine contractions abnormal +	19.5% 23/118 • Number of events 23 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	25.6% 32/125 • Number of events 33 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	41.2% 54/131 • Number of events 57 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.
Pregnancy, puerperium and perinatal conditions Uterine hypertonus +	3.4% 4/118 • Number of events 4 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	5.6% 7/125 • Number of events 7 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	6.9% 9/131 • Number of events 9 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.
Reproductive system and breast disorders Uterine atony #	4.2% 5/118 • Number of events 5 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	7.2% 9/125 • Number of events 9 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	4.6% 6/131 • Number of events 6 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome *	5.1% 6/118 • Number of events 6 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	3.2% 4/125 • Number of events 4 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.	3.8% 5/131 • Number of events 5 • All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first. All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.

Additional Information

Clinical Development Support

Ferring Pharmaceuticals

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Principal investigator is a sponsor employee Any abstract,presentation or manuscript proposed for publication must be submitted to the Sponsor for review at least 30 days prior to submission for any meeting or journal.If deemed necessary by the Sponsor for protection of proprietary information prior to patent filing,the Investigator agrees to a further delay of 60 days before any presentation or publication is submitted.Publications must be in a form that does not reveal technical information that is considered confidential or proprietary.
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