Trial Outcomes & Findings for Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery (NCT NCT01127581)

NCT ID: NCT01127581

Last Updated: 2014-05-01

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1358 participants

Primary outcome timeframe

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

Results posted on

2014-05-01

Participant Flow

Pregnant women who required to be induced were recruited at 35 sites in the US.

Participant milestones

Participant milestones
Measure	MVI 200 MVI 200 mcg vaginal insert MVI 200: 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.	Dinoprostone Vaginal Insert (DVI) 10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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	678	680
Overall Study COMPLETED	678	680
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MVI 200 n=678 Participants MVI 200 mcg vaginal insert MVI 200: 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.	Dinoprostone Vaginal Insert (DVI) n=680 Participants 10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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=1358 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	678 Participants n=5 Participants	680 Participants n=7 Participants	1358 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.2 years STANDARD_DEVIATION 5.99 • n=5 Participants	25.9 years STANDARD_DEVIATION 5.95 • n=7 Participants	26.0 years STANDARD_DEVIATION 5.96 • n=5 Participants
Sex: Female, Male Female	678 Participants n=5 Participants	680 Participants n=7 Participants	1358 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	678 participants n=5 Participants	680 participants n=7 Participants	1358 participants n=5 Participants

PRIMARY outcome

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

Population: Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery, independent of treatment assignment. Subjects who were discharged prior to delivery or withdrew consent prior to delivery were also censored.

Outcome measures

Outcome measures
Measure	MVI 200 n=678 Participants MVI 200 mcg vaginal insert MVI 200: 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.	Dinoprostone Vaginal Insert (DVI) n=680 Participants 10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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 During the First Hospital Admission	1292.00 minutes Interval 1200.0 to 1402.0	1968.50 minutes Interval 1812.0 to 2093.0

PRIMARY outcome

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

Population: Analysis was based on a between-treatment-group difference in the safety population. Subjects discharged prior to delivery, withdrew early without having a cesarean delivery or were lost-to-follow up were classified as not having the event.

Outcome measures

Outcome measures
Measure	MVI 200 n=678 Participants MVI 200 mcg vaginal insert MVI 200: 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.	Dinoprostone Vaginal Insert (DVI) n=680 Participants 10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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.
Incidence of Cesarean Delivery During the First Hospital Admission	25.96 percentage of participants Interval 22.7 to 29.43	27.06 percentage of participants Interval 23.75 to 30.57

SECONDARY outcome

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

Population: Subjects who did not deliver during the first hospitalization were censored at the time of labour and delivery discharge.

Outcome measures

Outcome measures
Measure	MVI 200 n=678 Participants MVI 200 mcg vaginal insert MVI 200: 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.	Dinoprostone Vaginal Insert (DVI) n=680 Participants 10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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 Any Delivery (Vaginal or Cesarean) During the First Hospital Admission	1096.50 minutes Interval 1031.0 to 1170.0	1639.50 minutes Interval 1573.0 to 1731.0

SECONDARY outcome

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

Population: Intention-to-Treat (ITT) population

Active labor was defined as progressive cervical dilatation to 4 cm with any frequency of contractions OR rhythmic, firm, adequate quality uterine contractions causing progressive cervical change occurring at a frequency of 3 or more in 10 minutes and lasting 45 seconds or more.

Outcome measures

Outcome measures
Measure	MVI 200 n=678 Participants MVI 200 mcg vaginal insert MVI 200: 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.	Dinoprostone Vaginal Insert (DVI) n=680 Participants 10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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 Active Labor During the First Hospital Admission	726.50 minutes Interval 719.0 to 773.0	1116.50 minutes Interval 1083.0 to 1352.0

SECONDARY outcome

Timeframe: At least 30 minutes after study drug removal

Population: Analysis population includes subjects who delivered during the first hospitalization.

Percentage of participants in receipt of Oxytocin for induction after study drug removal.

Outcome measures

Outcome measures
Measure	MVI 200 n=674 Participants MVI 200 mcg vaginal insert MVI 200: 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.	Dinoprostone Vaginal Insert (DVI) n=671 Participants 10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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.
Incidence of Pre-delivery Oxytocin During the First Hospital Admission	48.1 percentage of participants Interval 44.24 to 51.92	74.1 percentage of participants Interval 70.58 to 77.35

SECONDARY outcome

Timeframe: Interval from study drug administration to vaginal delivery within 12 hours

Population: Intention-to-Treat (ITT) population

Outcome measures

Outcome measures
Measure	MVI 200 n=678 Participants MVI 200 mcg vaginal insert MVI 200: 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.	Dinoprostone Vaginal Insert (DVI) n=680 Participants 10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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.
Incidence of Vaginal Delivery Within 12 Hours	19.76 percentage of participants Interval 16.83 to 22.96	8.38 percentage of participants Interval 6.41 to 10.72

SECONDARY outcome

Timeframe: Interval from study drug administration to delivery of neonate within 24 hours

Population: Intention-to-Treat (ITT) Population

Outcome measures

Outcome measures
Measure	MVI 200 n=678 Participants MVI 200 mcg vaginal insert MVI 200: 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.	Dinoprostone Vaginal Insert (DVI) n=680 Participants 10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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.
Incidence of Any Delivery Within 24 Hours	67.70 percentage of participants Interval 64.03 to 71.21	40.74 percentage of participants Interval 37.02 to 44.54

SECONDARY outcome

Timeframe: Interval from study drug administration to delivery of neonate within 12 hours

Population: Intention-to-Treat (ITT) Population

Outcome measures

Outcome measures
Measure	MVI 200 n=678 Participants MVI 200 mcg vaginal insert MVI 200: 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.	Dinoprostone Vaginal Insert (DVI) n=680 Participants 10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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.
Incidence of Any Delivery Within 12 Hours	23.16 percentage of participants Interval 20.03 to 26.52	9.26 percentage of participants Interval 7.19 to 11.7

SECONDARY outcome

Timeframe: Interval from study drug administration to vaginal delivery within 24 hours

Population: Intention-to-Treat (ITT) Population

Outcome measures

Outcome measures
Measure	MVI 200 n=678 Participants MVI 200 mcg vaginal insert MVI 200: 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.	Dinoprostone Vaginal Insert (DVI) n=680 Participants 10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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.
Incidence of Vaginal Delivery Within 24 Hours	54.57 percentage of participants Interval 50.74 to 58.37	33.97 percentage of participants Interval 30.41 to 37.67

SECONDARY outcome

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

Population: The Intention-to-Treat (ITT) population was used for all secondary efficacy analyses.

Outcome measures

Outcome measures
Measure	MVI 200 n=678 Participants MVI 200 mcg vaginal insert MVI 200: 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.	Dinoprostone Vaginal Insert (DVI) n=680 Participants 10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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.
Incidence of Vaginal Delivery	73.30 percentage of participants Interval 69.8 to 76.6	71.62 percentage of participants Interval 68.07 to 74.98

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.

Outcome measures

Outcome measures
Measure	MVI 200 n=678 Participants MVI 200 mcg vaginal insert MVI 200: 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.	Dinoprostone Vaginal Insert (DVI) n=680 Participants 10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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 an Intrapartum Adverse Events	55.5 percentage of participants	54.6 percentage of participants
Rate of Adverse Events Subjects with Maternal Postpartum Adverse Events	21.4 percentage of participants	21.2 percentage of participants
Rate of Adverse Events Subjects with Neonatal Adverse Events	53.4 percentage of participants	58.1 percentage of participants

Adverse Events

MVI 200

Serious events: 130 serious events

Other events: 520 other events

Deaths: 0 deaths

Dinoprostone Vaginal Insert (DVI)

Serious events: 107 serious events

Other events: 533 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	MVI 200 n=678 participants at risk MVI 200 mcg vaginal insert MVI 200: 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.	Dinoprostone Vaginal Insert (DVI) n=680 participants at risk 10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI 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.
Pregnancy, puerperium and perinatal conditions Abnormal labour affecting foetus +	8.7% 59/678 • Number of events 62 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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.	2.8% 19/680 • Number of events 19 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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 Arrested labour +	14.2% 96/678 • Number of events 96 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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.	18.8% 128/680 • Number of events 129 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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 *	8.6% 58/678 • Number of events 58 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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% 60/680 • Number of events 60 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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 +	5.6% 38/678 • Number of events 38 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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.	8.7% 59/680 • Number of events 59 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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 +	18.3% 124/678 • Number of events 138 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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.	20.3% 138/680 • Number of events 160 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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 *	9.1% 62/678 • Number of events 62 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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.	11.5% 78/680 • Number of events 78 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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 +	17.7% 120/678 • Number of events 120 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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.	13.5% 92/680 • Number of events 92 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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 #	5.9% 40/678 • Number of events 41 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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.	5.4% 37/680 • Number of events 37 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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 *	27.1% 184/678 • Number of events 184 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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.	28.5% 194/680 • Number of events 194 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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 depression *	5.0% 34/678 • Number of events 34 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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.	4.4% 30/680 • Number of events 30 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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.
Surgical and medical procedures Infection prophylaxis *	6.8% 46/678 • Number of events 46 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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.	9.3% 63/680 • Number of events 63 • All adverse events were followed until resolution or at least 30 days after discontinuation of the 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

Email: [email protected]

Results disclosure agreements

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.
Publication restrictions are in place

Restriction type: OTHER