Efficacy & Safety Study Comparing Misoprostol Vaginal Ins... | NCT01127581

NCT01127581

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MVI 200	Experimental	MVI 200 mcg vaginal insert	Drug: MVI 200
Dinoprostone Vaginal Insert (DVI)	Active Comparator	10 mg Dinoprostone vaginal insert	Drug: Dinoprostone Vaginal Insert (DVI)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MVI 200	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Vaginal Delivery During the First Hospital Admission		Interval from study drug administration to vaginal delivery (average 24 hours)
Incidence of Cesarean Delivery During the First Hospital Admission		Interval from study drug administration to cesarean delivery (average 24 hours)

Secondary Outcomes

Measure	Description	Time Frame
Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission		Interval from study drug administration to neonate delivery (average 24 hours)
Time to Active Labor During the First Hospital Admission	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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Maricopa Medical Center - District Medical Group		Phoenix	Arizona		United States
Precision Trials

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25758619	Derived	Miller H, Goetzl L, Wing DA, Powers B, Rugarn O. Optimising daytime deliveries when inducing labour using prostaglandin vaginal inserts. J Matern Fetal Neonatal Med. 2016;29(4):517-22. doi: 10.3109/14767058.2015.1011117. Epub 2015 Mar 16.
23857539	Derived	Wing DA, Brown R, Plante LA, Miller H, Rugarn O, Powers BL. Misoprostol vaginal insert and time to vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2013 Aug;122(2 Pt 1):201-209. doi: 10.1097/AOG.0b013e31829a2dd6.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00026.2± 5.99 BG00125.9± 5.95 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000678 BG001680 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000678 BG001680 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Vaginal Delivery During the First Hospital Admission

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.

Posted

Median

95% Confidence Interval

minutes

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000678 OG001680

Title

Denominators

Categories

Title	Measurements
	OG0001292.00(1200.00 to 1402.00) OG0011968.50(1812.00 to 2093.00)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.	Log Rank		<0.001		Median Difference (Net)	-677			2-Sided	95					Sample size 675 per group provides 90% power to see an improvement of ≥320 minutes (20% improvement from DVI) in time to vaginal delivery between MVI 200 & DVI assuming a median time of 1600 minutes for DVI & 34% dropout rate based on 5% 2-sided test

Primary

Incidence of Cesarean Delivery During the First Hospital Admission

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.

Posted

Number

95% Confidence Interval

percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission

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

Posted

Median

95% Confidence Interval

minutes

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Time to Active Labor During the First Hospital Admission

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.

Intention-to-Treat (ITT) population

Posted

Median

95% Confidence Interval

minutes

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Incidence of Pre-delivery Oxytocin During the First Hospital Admission

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

Analysis population includes subjects who delivered during the first hospitalization.

Posted

Number

95% Confidence Interval

percentage of participants

At least 30 minutes after study drug removal

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Incidence of Vaginal Delivery Within 12 Hours

Intention-to-Treat (ITT) population

Posted

Number

95% Confidence Interval

percentage of participants

Interval from study drug administration to vaginal delivery within 12 hours

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Incidence of Any Delivery Within 24 Hours

Intention-to-Treat (ITT) Population

Posted

Number

95% Confidence Interval

percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Incidence of Any Delivery Within 12 Hours

Intention-to-Treat (ITT) Population

Posted

Number

95% Confidence Interval

percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Incidence of Vaginal Delivery Within 24 Hours

Intention-to-Treat (ITT) Population

Posted

Number

95% Confidence Interval

percentage of participants

Interval from study drug administration to vaginal delivery within 24 hours

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Incidence of Vaginal Delivery

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

Posted

Number

95% Confidence Interval

percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Rate of Adverse Events

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.

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

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			130	678	520	678
EG001	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.			107	680	533	680

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Disseminated intravascular coagulation #	Blood and lymphatic system disorders	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Polycythaemia *	Blood and lymphatic system disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Pericarditis #	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Supraventricular tachycardia *	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Supraventricular tachycardia +	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	+ Intrapartum Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Adrenogenital syndrome *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Anal atresia *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Ankyloglossia congenital *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0003 events3 affected678 at risk EG0012 events2 affected680 at risk
Anomalous pulmonary venous connection *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Atrial septal defect *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0008 events8 affected678 at risk EG0016 events6 affected680 at risk
Cataract congenital *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Congenital choroid plexus cyst *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Congenital hydronephrosis *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Congenital nose malformation *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Congenital pyelocaliectasis *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0011 events1 affected680 at risk
Cryptorchism *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0006 events6 affected678 at risk EG0012 events2 affected680 at risk
Hydrocele *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0011 events1 affected680 at risk
Hypospadias *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0004 events4 affected678 at risk EG0014 events4 affected680 at risk
Patent ductus arteriosus *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0004 events4 affected678 at risk EG0014 events4 affected680 at risk
Penile torsion *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0003 events3 affected678 at risk EG0011 events1 affected680 at risk
Phimosis *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0013 events3 affected680 at risk
Pilonidal cyst congenital *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0003 events3 affected678 at risk EG0017 events7 affected680 at risk
Polydactyly *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0003 events3 affected678 at risk EG0013 events3 affected680 at risk
Pulmonary artery stenosis congenital *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Supernumerary nipple *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0012 events2 affected680 at risk
Syndactyly *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Talipes *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
VACTERL syndrome *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0002 events2 affected678 at risk EG0010 events0 affected680 at risk
Ventricular septal defect *	Congenital, familial and genetic disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0004 events4 affected678 at risk EG0011 events1 affected680 at risk
Vitreous haemorrhage *	Eye disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Anal fistula *	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Intestinal obstruction *	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Salivary gland enlargement *	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Fever neonatal *	General disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Endometritis #	Infections and infestations	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0002 events2 affected678 at risk EG0011 events1 affected680 at risk
Pneumonia *	Infections and infestations	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Pneumonia #	Infections and infestations	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Postpartum sepsis #	Infections and infestations	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Sepsis neonatal *	Infections and infestations	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0011 events1 affected680 at risk
Septic shock *	Infections and infestations	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Skull fracture *	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Urine output decreased *	Investigations	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0011 events1 affected680 at risk
Feeding disorder neonatal *	Metabolism and nutrition disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0012 events2 affected680 at risk
Joint crepitation *	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0011 events1 affected680 at risk
Muscular weakness #	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Dysaesthesia #	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Encephalopathy neonatal *	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Hypoxic-ischaemic encephalopathy *	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0004 events4 affected678 at risk EG0010 events0 affected680 at risk
Paraesthesia #	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Abnormal labour affecting foetus +	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	+ Intrapartum Event	EG00013 events13 affected678 at risk EG0010 events0 affected680 at risk
Drug withdrawal syndrome neonatal *	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0011 events1 affected680 at risk
Erb's palsy *	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Foetal acidosis *	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Foetal heart rate disorder +	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	+ Intrapartum Event	EG00065 events65 affected678 at risk EG00146 events46 affected680 at risk
Hypoglycaemia neonatal *	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0003 events3 affected678 at risk EG0012 events2 affected680 at risk
Neonatal disorder *	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Postpartum haemorrhage #	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0002 events2 affected678 at risk EG0013 events3 affected680 at risk
Premature separation of placenta +	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	+ Intrapartum Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Puerperal pyrexia #	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Retained placenta or membranes #	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Uterine contractions abnormal +	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	+ Intrapartum Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Uterine rupture +	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	+ Intrapartum Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Weight decrease neonatal *	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0011 events1 affected680 at risk
Anxiety #	Psychiatric disorders	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Hydronephrosis *	Renal and urinary disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Chordee *	Reproductive system and breast disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Testicular torsion *	Reproductive system and breast disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Vulval haematoma #	Reproductive system and breast disorders	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Neonatal aspiration *	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0012 events2 affected680 at risk
Neonatal respiratory depression *	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Neonatal respiratory distress syndrome *	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Pneumothorax *	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected678 at risk EG0011 events1 affected680 at risk
Transient tachypnoea of the newborn *	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Deep vein thrombosis #	Vascular disorders	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0001 events1 affected678 at risk EG0010 events0 affected680 at risk
Hypertension #	Vascular disorders	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG0001 events1 affected678 at risk EG0011 events1 affected680 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abnormal labour affecting foetus +	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	+ Intrapartum Event	EG00062 events59 affected678 at risk EG00119 events19 affected680 at risk
Arrested labour +	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	+ Intrapartum Event	EG00096 events96 affected678 at risk EG001129 events128 affected680 at risk
Caput succedaneum *	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG00058 events58 affected678 at risk EG00160 events60 affected680 at risk
Chorioamnionitis +	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	+ Intrapartum Event	EG00038 events38 affected678 at risk EG00159 events59 affected680 at risk
Foetal heart rate disorder +	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	+ Intrapartum Event	EG000138 events124 affected678 at risk EG001160 events138 affected680 at risk
Hyperbilirubinaemia neonatal *	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG00062 events62 affected678 at risk EG00178 events78 affected680 at risk
Meconium in amniotic fluid +	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	+ Intrapartum Event	EG000120 events120 affected678 at risk EG00192 events92 affected680 at risk
Postpartum haemorrhage #	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	# Postpartum Event	EG00041 events40 affected678 at risk EG00137 events37 affected680 at risk
Umbilical cord around neck *	Pregnancy, puerperium and perinatal conditions	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG000184 events184 affected678 at risk EG001194 events194 affected680 at risk
Neonatal respiratory depression *	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG00034 events34 affected678 at risk EG00130 events30 affected680 at risk
Infection prophylaxis *	Surgical and medical procedures	MedDRA (13.1)	Systematic Assessment	* Neonatal Event	EG00046 events46 affected678 at risk EG00163 events63 affected680 at risk

ID	Term
D015232	Dinoprostone

Ancestor Terms

ID	Term
D011458	Prostaglandins E
D011453	Prostaglandins
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids
D008055	Lipids
D012898	Autacoids
D018836	Inflammation Mediators
D001685	Biological Factors

Units	Counts
Participants	OG000678 OG001680

Units	Counts
Participants	OG000678 OG001680