RCT of Progesterone to Prevent Preterm Birth in Nulliparo... | NCT00439374

Secondary IDs

ID	Type	Link
U10HD021410	U.S. NIH Grant/Contract	View source
U10HD027869	U.S. NIH Grant/Contract	View source
U10HD027917	U.S. NIH Grant/Contract	View source
U10HD053097	U.S. NIH Grant/Contract	View source
U10HD027915	U.S. NIH Grant/Contract	View source
U10HD034116	U.S. NIH Grant/Contract	View source
U10HD034208	U.S. NIH Grant/Contract	View source
U10HD034136	U.S. NIH Grant/Contract	View source
U10HD040500	U.S. NIH Grant/Contract	View source
U10HD040485	U.S. NIH Grant/Contract	View source
U10HD040544	U.S. NIH Grant/Contract	View source
U10HD040545	U.S. NIH Grant/Contract	View source
U10HD040560	U.S. NIH Grant/Contract	View source
U10HD040512	U.S. NIH Grant/Contract	View source
U10HD036801	U.S. NIH Grant/Contract	View source
U10HD053118	U.S. NIH Grant/Contract	View source

Status Module

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH

Oversight Module

Description 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
17 alpha-hydroxyprogesterone caproate	Active Comparator	250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery	Drug: 17 alpha-hydroxyprogesterone caproate
Placebo	Placebo Comparator	Placebo oil given by weekly injection until 37 weeks gestation or delivery.	Other: Placebo Oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
17 alpha-hydroxyprogesterone caproate	Drug	Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Delivering Before 37 Weeks Gestation	Number of participants delivering before 37 weeks gestation by indication	Delivery before 37 weeks gestation

Measure	Description	Time Frame
Mean Gestational Age at Delivery	Mean gestational age at delivery	Delivery
Number of Participants With Preterm Premature Rupture of Membranes		<37 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
William Grobman, MD, MBA	Northwestern University	Principal Investigator
Menachem Miodovnik, MD	NICHD Project Scientist	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama - Birmingham		Birmingham	Alabama	35429	United States
Northwestern University-Prentice Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23010094	Derived	Grobman WA, Thom EA, Spong CY, Iams JD, Saade GR, Mercer BM, Tita AT, Rouse DJ, Sorokin Y, Wapner RJ, Leveno KJ, Blackwell S, Esplin MS, Tolosa JE, Thorp JM Jr, Caritis SN, Van Dorsten JP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network. 17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm. Am J Obstet Gynecol. 2012 Nov;207(5):390.e1-8. doi: 10.1016/j.ajog.2012.09.013. Epub 2012 Sep 17.

Label	URL
Click here for more information about the SCAN protocol	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
BG001	Placebo	castor oil
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, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Total Delivery <37 wk

Title	Measurements
	OG00082 OG00180

Spontaneous

Title	Measurements
	OG000

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	All deliveries less than 37 weeks					Risk Ratio (RR)	1.03			2-Sided	95	0.79	1.35					Superiority or Other
OG000 OG001	Spontaneous deliveries

Secondary

Mean Gestational Age at Delivery

Mean gestational age at delivery

Posted

Mean

Standard Deviation

weeks

Delivery

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Participants With Preterm Premature Rupture of Membranes

Posted

Count of Participants

Participants

<37 weeks

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Delivered Before 35 Weeks Gestation

Delivery before 35 weeks gestation

Posted

Count of Participants

Participants

Delivery

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Delivered Before 32 Weeks Gestation

Delivery before 32 weeks gestation

Posted

Count of Participants

Participants

Delivery

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Delivered Before 28 Weeks Gestation

Delivery before 28 weeks gestation

Posted

Count of Participants

Participants

Delivery

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Visited the Hospital Due to Preterm Labor

Number of participants who visited the hospital due to preterm labor before 37 weeks gestation

Posted

Count of Participants

Participants

Between randomization and 37 weeks gestation

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Underwent Tocolytic Therapy

Number of participants who underwent tocolytic therapy during pregnancy

Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.

Posted

Count of Participants

Participants

Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants

Secondary

Number of Participants Who Underwent Corticosteroid Therapy

Number of participants who underwent corticosteroid therapy in pregnancy

Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.

Posted

Count of Participants

Participants

Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants

Secondary

Number of Participants Who Had a Cerclage Placement

Number of participants who had a cerclage placement

Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.

Posted

Count of Participants

Participants

Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Participants Experiencing Gestational Hypertension or Preeclampsia

Data was missing for 1 participant in the placebo group.

Posted

Count of Participants

Participants

Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Participants With Gestational Diabetes Mellitus

Posted

Count of Participants

Participants

Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Participants Experiencing Cholestasis

Data was missing for 1 participant in the Placebo group

Posted

Count of Participants

Participants

Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Experienced Placental Abruption

Data was missing for 2 participants in the placebo group.

Posted

Count of Participants

Participants

Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Experienced Chorioamnionitis

Data was missing for 2 participants in the placebo group.

Posted

Count of Participants

Participants

Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Had Cesarean Delivery

Data was missing for 1 participant in the placebo group.

Posted

Count of Participants

Participants

delivery

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Reported Side Effects

Number of participants who reported any side effect, nausea, urticaria, and/or an issue at the injection site

Data was missing for 1 participant in the treatment group and 2 participants in the placebo group.

Posted

Count of Participants

Participants

Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants

Secondary

Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components

comprised of fetal or infant death, respiratory distress syndrome, intraventricular hemorrhage (grades 3 and 4), periventricular leukomalacia, necrotizing enterocolitis (stage II and III), Bronchopulmonary dysplasia /chronic lung disease, retinopathy of prematurity (stage III or higher), early onset sepsis

With the exception of the composite outcome and death, the neonatal outcomes were only measured for live births.

Posted

Count of Participants

Participants

within 72 hours of delivery

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts

Secondary

Mean Birth Weight

Birth weight as measured in grams

Posted

Mean

Standard Deviation

Grams

Delivery

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Birth Weight by Count of Participants

Birth weight by count of participants < 2500 grams and < 1500 grams

Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.

Posted

Count of Participants

Participants

Delivery

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Neonates Who Measured Small for Gestational Age

Birth weight percentile and small for gestational age <10th percentile based on number of weeks and gender.

Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.

Posted

Count of Participants

Participants

Delivery

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Participants With Apgar Score of Less Than 7 at 5 Minutes

The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score.

Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.

Posted

Count of Participants

Participants

5 minutes post delivery

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.

Secondary

Number of Neonates With a Major Congenital Anomaly

Presence of a major congenital anomaly at birth

Data was missing for 1 participant in the treatment group and 2 participants in the placebo group.

Posted

Count of Participants

Participants

Delivery

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Neonates With Patent Ductus Arteriosus

Number of neonates diagnosed with the heart defect patent ductus arteriosus

Data was missing for 7 participants in the treatment group and 8 participants in the placebo group.

Posted

Count of Participants

Participants

Delivery through neonatal discharge

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Neonates Experiencing Seizures

Number of neonates experiencing seizures from delivery to hospital discharge

Data was missing for 7 participants in the treatment group and 8 participants in the placebo group.

Posted

Count of Participants

Participants

Delivery through neonatal discharge

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Number of Neonates Admitted to NICU

Admission to the neonatal intensive care unit

Data was missing for 5 participants in the treatment group and 1 participant in the placebo group.

Posted

Count of Participants

Participants

Delivery through hospital discharge

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

Secondary

Median Length of NICU Stay

Median length of stay in the neonatal intensive care unit in days

Data was missing for 5 participants in the treatment group and 1 participant in the placebo group.

Posted

Median

Inter-Quartile Range

days

NICU admission through NICU discharge

ID	Title	Description
OG000	17 Alpha-hydroxyprogesterone Caproate	17 alpha-hydroxyprogesterone caproate 17 alpha-hydroxyprogesterone caproate : Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OG001	Placebo	castor oil

Units	Counts
Participants	OG000

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	17 Alpha-hydroxyprogesterone Caproate	250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery 17 alpha-hydroxyprogesterone caproate: Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.			22	327	326	326
EG001	Placebo	Placebo oil given by weekly injection until 37 weeks gestation or delivery. Placebo Oil: Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative			13	330	328	328

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Miscarriage or stillbirth	Pregnancy, puerperium and perinatal conditions	Systematic Assessment	Miscarriage, antepartum stillbirth, intrapartum stillbirth	EG0005 affected327 at risk EG0011 affected330 at risk
Placental abruption	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment		EG0002 affected327 at risk EG0012 affected330 at risk
Pregnancy Complications	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	advanced cervical dilation, oligohydramnios, preterm rupture of the membranes	EG0003 affected327 at risk EG0013 affected330 at risk
Chest Pain	Vascular disorders	Non-systematic Assessment		EG0001 affected327 at risk EG0010 affected330 at risk
Epistaxis	Vascular disorders	Non-systematic Assessment	Nosebleed	EG0001 affected327 at risk EG0010 affected330 at risk
Maternal Pulmonary edema	Cardiac disorders	Non-systematic Assessment	due to anemia and cardiac insufficiency	EG0001 affected327 at risk EG0010 affected330 at risk
Maternal blood disorders	Blood and lymphatic system disorders	Non-systematic Assessment	Pulmonary embolism, thrombocytopenia	EG0002 affected327 at risk EG0010 affected330 at risk
Congenital Anomalies	Congenital, familial and genetic disorders	Non-systematic Assessment	ovarian cyst, esophageal atresia, flexion contracture, hypospadias, patent ductus arteriosis, polydactyly, torticollis, Trisomy 21	EG0005 affected327 at risk EG0013 affected330 at risk
Neonatal death	General disorders	Non-systematic Assessment		EG0006 affected327 at risk EG0018 affected330 at risk
Neonatal Hematochromatosis	Blood and lymphatic system disorders	Non-systematic Assessment		EG0001 affected327 at risk EG0010 affected330 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Headache	General disorders	Non-systematic Assessment	EG0007 affected326 at risk EG0018 affected328 at risk
Fatigue	General disorders	Non-systematic Assessment	EG0005 affected326 at risk EG0012 affected328 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0007 affected326 at risk EG00110 affected328 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0006 affected326 at risk EG0013 affected328 at risk
Diarrhea	Gastrointestinal disorders	Non-systematic Assessment	EG0002 affected326 at risk EG0016 affected328 at risk
Reaction at injection site	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG000217 affected326 at risk EG001210 affected328 at risk
Sore/burn at injection site	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG000145 affected326 at risk EG001153 affected328 at risk
Itching at injection site	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG000121 affected326 at risk EG001109 affected328 at risk
Swelling/lump at injection site	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG000107 affected326 at risk EG00193 affected328 at risk
Bruising at injection site	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG00026 affected326 at risk EG00123 affected328 at risk
Redness at injection site	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0008 affected326 at risk EG00111 affected328 at risk
Urticaria	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG00010 affected326 at risk EG0012 affected328 at risk

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D019326	17-alpha-Hydroxyprogesterone
D006908	Hydroxyprogesterones
D011374	Progesterone
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D045167	Progesterone Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists