Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Ce... | NCT00828711

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MVI 100	Experimental	MVI 100 mcg vaginal insert	Drug: MVI 100
MVI 150	Experimental	MVI 150 mcg vaginal insert	Drug: MVI 150
MVI 200	Experimental	MVI 200 mcg vaginal insert	Drug: MVI 200

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MVI 100	Drug	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.

Outcomes Module

Measure	Description	Time Frame
Proportion of Women Delivering Vaginally		Interval from study drug administration to 24 hours

Secondary Outcomes

Measure	Description	Time Frame
Time to Vaginal Delivery		Interval from study drug administration to delivery (average 24 hours)
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. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.

Eligibility Module

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Precision Trials		Phoenix	Arizona	85032	United States
Tuscon Medical Center

PubMed Identifier	Type	Citation	Retractions
21343755	Derived	Wing DA, Miller H, Parker L, Powers BL, Rayburn WF; Misoprostol Vaginal Insert Miso-Obs-204 Investigators. Misoprostol vaginal insert for successful labor induction: a randomized controlled trial. Obstet Gynecol. 2011 Mar;117(3):533-541. doi: 10.1097/AOG.0b013e318209d669.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG000117 BG001125 BG002131 BG003373

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

Proportion of Women Delivering Vaginally

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

Posted

Number

95% Confidence Interval

percentage of participants

Interval from study drug administration to 24 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Units	Counts
Participants	OG00080 OG00187 OG002100

Title

Denominators

Categories

Title	Measurements
	OG00063.75(52.24 to 74.21) OG00166.67(55.75 to 76.42) OG00276.00(66.43 to 83.98)

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 OG002	The primary objective of this study is to compare the efficacy of MVI 100 and MVI 200 based on the proportion of vaginal deliveries within 24 hours. A minimum sample size of approximately 120 subjects per arm would provide 84 subjects per arm with vaginal delivery, which would ensure >80% power (with two-sided alpha of 5%) to detect a 20% improvement in the proportion of women delivering vaginally within 24 hours	Cochran-Mantel-Haenszel	Adjusted for site effect	0.057		Difference in Proportions	12.20			2-Sided	95					MVI 200 - MVI 100	No

Secondary

Time to Vaginal Delivery

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

Posted

Median

95% Confidence Interval

minutes

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	MVI 200

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. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.

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 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.
OG001	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.

Secondary

Proportion of Cesarean Delivery

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

Posted

Number

95% Confidence Interval

percentage of participants

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Cervical Ripening Using Composite Measure of Success

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.

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

Posted

Number

95% Confidence Interval

percentage of participants

12 hours after insertion of drug

ID	Title	Description
OG000	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.
OG001	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.
OG002

Secondary

Use of Oxytocin

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

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

Posted

Number

95% Confidence Interval

percentage of participants

At least 30 minutes after study drug removal

ID	Title	Description
OG000	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.
OG001	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.
OG002	MVI 200

Secondary

Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid.

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.

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.

Posted

Number

PK Parameters

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Time to Onset of Active Labor

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)

Posted

Median

95% Confidence Interval

minutes

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

ID	Title	Description
OG000	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.
OG001	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.
OG002	MVI 200

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	43	118	100	118
EG001	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.	48	125	107	125
EG002	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.	42	131	117	131

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Ankyloglossia congenital *	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Atrial septal defect *	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected118 at risk EG0010 events0 affected125 at risk EG0021 events1 affected131 at risk
Dysmorphism *	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected118 at risk EG0010 events0 affected125 at risk EG0021 events1 affected131 at risk
Polydactyly *	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected118 at risk EG0013 events3 affected125 at risk EG0025 events5 affected131 at risk
Supernumerary nipple *	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected118 at risk EG0010 events0 affected125 at risk EG0021 events1 affected131 at risk
Syndactyly *	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Dacryostenosis congenital *	Eye disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Fever neonatal *	General disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Congenital syphilis *	Infections and infestations	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected118 at risk EG0011 events1 affected125 at risk EG0020 events0 affected131 at risk
Endometritis #	Infections and infestations	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG0000 events0 affected118 at risk EG0011 events1 affected125 at risk EG0021 events1 affected131 at risk
Herpes simplex *	Infections and infestations	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Postoperative wound infection #	Infections and infestations	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG0000 events0 affected118 at risk EG0010 events0 affected125 at risk EG0021 events1 affected131 at risk
Arterial injury #	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Post procedural haemorrhage #	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Medical observation *	Investigations	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected118 at risk EG0010 events0 affected125 at risk EG0021 events1 affected131 at risk
Urine cannabinoids increased +	Investigations	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG0000 events0 affected118 at risk EG0011 events1 affected125 at risk EG0020 events0 affected131 at risk
Dehydration *	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected118 at risk EG0011 events1 affected125 at risk EG0020 events0 affected131 at risk
Feeding disorder neonatal *	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected118 at risk EG0012 events2 affected125 at risk EG0021 events1 affected131 at risk
Haemorrhage intracranial *	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected118 at risk EG0010 events0 affected125 at risk EG0021 events1 affected131 at risk
Hydrocephalus *	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected118 at risk EG0010 events0 affected125 at risk EG0021 events1 affected131 at risk
Abnormal labour affecting foetus +	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Arrested labour +	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG00015 events15 affected118 at risk EG00116 events16 affected125 at risk EG00211 events11 affected131 at risk
Chorioamnionitis +	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG0002 events2 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Drug withdrawal syndrome neonatal +	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0022 events2 affected131 at risk
Foetal heart rate disorder +	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG00011 events11 affected118 at risk EG00112 events12 affected125 at risk EG00218 events18 affected131 at risk
Foetal malpresentation +	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG0000 events0 affected118 at risk EG0011 events1 affected125 at risk EG0020 events0 affected131 at risk
Hyperbilirubinaemia neonatal *	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0003 events3 affected118 at risk EG0017 events7 affected125 at risk EG0026 events6 affected131 at risk
Hypoglycaemia neonatal *	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected118 at risk EG0012 events2 affected125 at risk EG0022 events2 affected131 at risk
Neonatal disorder *	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected118 at risk EG0011 events1 affected125 at risk EG0020 events0 affected131 at risk
Postpartum haemorrhage #	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Pre-eclampsia +	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG0000 events0 affected118 at risk EG0011 events1 affected125 at risk EG0020 events0 affected131 at risk
Pre-eclampsia #	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Puerperal pyrexia #	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG0000 events0 affected118 at risk EG0011 events1 affected125 at risk EG0020 events0 affected131 at risk
Small for dates baby *	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0000 events0 affected118 at risk EG0011 events1 affected125 at risk EG0020 events0 affected131 at risk
Uterine cervical laceration during labour #	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG0000 events0 affected118 at risk EG0010 events0 affected125 at risk EG0021 events1 affected131 at risk
Renal failure acute #	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Penis disorder *	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Vaginal haematoma #	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Vulval haematoma +	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Neonatal hypoxia *	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0001 events1 affected118 at risk EG0010 events0 affected125 at risk EG0020 events0 affected131 at risk
Pulmonary oedema #	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG0000 events0 affected118 at risk EG0011 events1 affected125 at risk EG0020 events0 affected131 at risk
Infection prophylaxis *	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0002 events2 affected118 at risk EG0012 events2 affected125 at risk EG0020 events0 affected131 at risk
Hypertension #	Vascular disorders	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG0000 events0 affected118 at risk EG0010 events0 affected125 at risk EG0021 events1 affected131 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia #	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG00010 events10 affected118 at risk EG0018 events8 affected125 at risk EG00211 events11 affected131 at risk
Abnormal labour affecting foetus +	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG0008 events8 affected118 at risk EG00114 events12 affected125 at risk EG00216 events16 affected131 at risk
Caput succedaneum *	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0004 events4 affected118 at risk EG0015 events5 affected125 at risk EG0027 events7 affected131 at risk
Chorioamnionitis +	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG0005 events5 affected118 at risk EG0017 events7 affected125 at risk EG0022 events2 affected131 at risk
Foetal heart rate disorder +	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG00096 events67 affected118 at risk EG00179 events62 affected125 at risk EG00287 events57 affected131 at risk
Hyperbilirubinaemia neonatal *	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0009 events9 affected118 at risk EG0016 events6 affected125 at risk EG00210 events10 affected131 at risk
Meconium in amniotic fluid +	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG00015 events15 affected118 at risk EG00113 events13 affected125 at risk EG00222 events22 affected131 at risk
Postpartum haemorrhage #	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG0004 events4 affected118 at risk EG0015 events5 affected125 at risk EG0028 events8 affected131 at risk
Umbilical cord around neck *	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG00014 events14 affected118 at risk EG00111 events11 affected125 at risk EG00222 events22 affected131 at risk
Uterine contractions abnormal +	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG00023 events23 affected118 at risk EG00133 events32 affected125 at risk EG00257 events54 affected131 at risk
Uterine hypertonus +	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	+ Intrapartum Event	EG0004 events4 affected118 at risk EG0017 events7 affected125 at risk EG0029 events9 affected131 at risk
Uterine atony #	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment	# Postpartum Event	EG0005 events5 affected118 at risk EG0019 events9 affected125 at risk EG0026 events6 affected131 at risk
Neonatal respiratory distress syndrome *	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	* Neonatal Event	EG0006 events6 affected118 at risk EG0014 events4 affected125 at risk EG0025 events5 affected131 at risk