Trial · NCT01004029

Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery

NCT01004029, Phase 3, Completed, AMAG Pharmaceuticals, Inc.; results first posted 2021-01-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery. Trials, record NCT01004029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01004029

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery
NCT number: NCT01004029
Status: Completed
Phases: Phase 3
Enrollment: 1,740 participants, actual
Lead sponsor: AMAG Pharmaceuticals, Inc.
Conditions: Preterm Birth
Interventions: Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL, Vehicle
First posted: 2009-10-29
Last updated: 2022-06-01
Results first posted: 2021-01-28

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Preterm Birth <35 Weeks Gestation	Up to 35 weeks	Determine if treatment with 17P reduces the rate of preterm birth \< 35 weeks, 0 days of gestation in women with a previous singleton spontaneous preterm delivery.
Primary	Neonatal Composite Index (NCI)	Until 28 days of life or discharge from the neonatal intensive care unit (NICU), whichever occurred later.	The composite index is defined as a liveborn neonate with any of the following occurring at any time during the birth hospitalization up through discharge from the NICU: neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis or proven sepsis.
Secondary	Fetal/Early Infant Death	Delivery from 16 weeks 0 days through 19 weeks 6 days of gestation; or neonatal death occurring in liveborns born at less than 24 weeks gestation; or stillbirth (antepartum or intrapartum death) from 20 weeks gestation through term).	Defined as spontaneous abortion/miscarriage (delivery from 16 weeks 0 days through 19 weeks 6 days of gestation) or neonatal death occurring in liveborns born at less than 24 weeks gestation or stillbirth (antepartum or intrapartum death from 20 weeks gestation through term), in the 17P group compared to the vehicle group
Secondary	Preterm Birth Prior to 32 Weeks Gestation	Up to 32 weeks
Secondary	Preterm Birth Prior to 37 Weeks Gestation	Up to 37 weeks
Secondary	Stillbirths	20 weeks gestation until term	Defined as all stillbirths/fetal deaths/in utero fetal losses occurring from 20 weeks gestation until term.
Secondary	Neonatal Deaths With ≥24 Weeks Gestational Age	Until 28 days of life or discharge from the NICU whichever occurred later.	Neonatal death (from minutes after birth until 28 days of life) occurring in liveborns born at 24 weeks gestation or greater

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Preterm Birth <35 Weeks Gestation	Up to 35 weeks	Number of ITT (intent to treat) subjects with non-missing delivery data or who were known to still be pregnant at 35 weeks	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Neonatal Composite Index (NCI)	Until 28 days of life or discharge from the neonatal intensive care unit (NICU), whichever occurred later.	Liveborn Neonatal Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Fetal/Early Infant Death	Delivery from 16 weeks 0 days through 19 weeks 6 days of gestation; or neonatal death occurring in liveborns born at less than 24 weeks gestation; or stillbirth (antepartum or intrapartum death) from 20 weeks gestation through term).	Intent to Treat (ITT) Population - all randomized subjects regardless of whether they received study medication.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Preterm Birth Prior to 32 Weeks Gestation	Up to 32 weeks	Intent to Treat (ITT) Population - all randomized subjects regardless of whether they received study medication.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Preterm Birth Prior to 37 Weeks Gestation	Up to 37 weeks	Intent to Treat (ITT) Population - all randomized subjects regardless of whether they received study medication.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Stillbirths	20 weeks gestation until term		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Neonatal Deaths With ≥24 Weeks Gestational Age	Until 28 days of life or discharge from the NICU whichever occurred later.	Liveborn Neonatal Population - all babies of randomized women who were liveborn and have morbidity data available.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Preterm Birth <35 Weeks Gestation	Vehicle	66	Participants
Preterm Birth <35 Weeks Gestation	17P (Hydroxyprogesterone Caproate Injection)	122	Participants
Neonatal Composite Index (NCI)	Vehicle	28	Participants
Neonatal Composite Index (NCI)	17P (Hydroxyprogesterone Caproate Injection)	61	Participants
Fetal/Early Infant Death	Vehicle	11	Participants
Fetal/Early Infant Death	17P (Hydroxyprogesterone Caproate Injection)	19	Participants
Preterm Birth Prior to 32 Weeks Gestation	Vehicle	30	Participants
Preterm Birth Prior to 32 Weeks Gestation	17P (Hydroxyprogesterone Caproate Injection)	54	Participants
Preterm Birth Prior to 37 Weeks Gestation	Vehicle	125	Participants
Preterm Birth Prior to 37 Weeks Gestation	17P (Hydroxyprogesterone Caproate Injection)	257	Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vehicle	578
Overall Study	STARTED	17P (Hydroxyprogesterone Caproate Injection)	1,130
Overall Study	Safety Population	Vehicle	578
Overall Study	Safety Population	17P (Hydroxyprogesterone Caproate Injection)	1,128
Overall Study	COMPLETED	Vehicle	530
Overall Study	COMPLETED	17P (Hydroxyprogesterone Caproate Injection)	1,057
Overall Study	NOT COMPLETED	Vehicle	48
Overall Study	NOT COMPLETED	17P (Hydroxyprogesterone Caproate Injection)	73

Source ClinicalTrials.gov

Adverse events152

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Vehicle	56	578
other	Anaemia	Blood and lymphatic system disorders	17P (Hydroxyprogesterone Caproate Injection)	104	1,128
other	Anaemia of pregnancy	Blood and lymphatic system disorders	Vehicle	18	578
other	Anaemia of pregnancy	Blood and lymphatic system disorders	17P (Hydroxyprogesterone Caproate Injection)	30	1,128
other	Abdominal pain	Gastrointestinal disorders	Vehicle	27	578
other	Abdominal pain	Gastrointestinal disorders	17P (Hydroxyprogesterone Caproate Injection)	40	1,128
other	Abdominal pain lower	Gastrointestinal disorders	Vehicle	7	578
other	Abdominal pain lower	Gastrointestinal disorders	17P (Hydroxyprogesterone Caproate Injection)	23	1,128
other	Constipation	Gastrointestinal disorders	Vehicle	17	578
other	Constipation	Gastrointestinal disorders	17P (Hydroxyprogesterone Caproate Injection)	38	1,128

1 to 10 of 152Source ClinicalTrials.gov

See all 152 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vehicle	0	578
Total, all-cause mortality	17P (Hydroxyprogesterone Caproate Injection)	0	1,130
Total, other adverse events	Vehicle	334	578
Total, other adverse events	17P (Hydroxyprogesterone Caproate Injection)	647	1,128
Total, serious adverse events	Vehicle	18	578
Total, serious adverse events	17P (Hydroxyprogesterone Caproate Injection)	34	1,128

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31652479	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons9

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Hydroxyprogesterone Caproate Injection, 250 mg/mL vs Vehicle: Stillbirths	Trial comparisons
17P (Hydroxyprogesterone Caproate Injection) vs Vehicle: Fetal/Early Infant Death	Trial comparisons
17P (Hydroxyprogesterone Caproate Injection) vs Vehicle: Neonatal Composite Index (NCI)	Trial comparisons
17P (Hydroxyprogesterone Caproate Injection) vs Vehicle: Preterm Birth Prior to 37 Weeks Gestation	Trial comparisons
17P (Hydroxyprogesterone Caproate Injection) vs Vehicle: Preterm Birth Prior to 32 Weeks Gestation	Trial comparisons
17P (Hydroxyprogesterone Caproate Injection) vs Vehicle: deaths from any cause	Trial comparisons
17P (Hydroxyprogesterone Caproate Injection) vs Vehicle: Neonatal Deaths With ≥24 Weeks Gestational Age	Trial comparisons
17P (Hydroxyprogesterone Caproate Injection) vs Vehicle: Preterm Birth <35 Weeks Gestation	Trial comparisons
17P (Hydroxyprogesterone Caproate Injection) vs Vehicle: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01004029

GET https://conductscience.org/api/trials/v1/NCT01004029/events?page=2

API reference For AI assistants