Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery (PROLONG)
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|ClinicalTrials.gov Identifier: NCT01004029|
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : January 28, 2021
Last Update Posted : January 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth||Drug: Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL Drug: Vehicle||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1740 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3B, Multi-Center, Randomized, Double-Blind Study of Hydroxyprogesterone Caproate (HPC) Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery|
|Actual Study Start Date :||October 2009|
|Actual Primary Completion Date :||October 2018|
|Actual Study Completion Date :||October 2018|
Placebo Comparator: Vehicle
Weekly intramuscular injections of 1 mL vehicle inert oil until 36 weeks, 6 days of gestation or delivery, whichever occurs first.
Other Name: Placebo
Active Comparator: Hydroxyprogesterone Caproate Injection (HPC), 250 mg/mL
HPC 250 mg/mL in oil
Drug: Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL
1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first.
- Preterm Birth <35 Weeks Gestation [ Time Frame: 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.
- Neonatal Composite Index (NCI) [ Time Frame: 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.
- Fetal/Early Infant Death [ Time Frame: 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
- Preterm Birth Prior to 32 Weeks Gestation [ Time Frame: Up to 32 weeks ]
- Preterm Birth Prior to 37 Weeks Gestation [ Time Frame: Up to 37 weeks ]
- Stillbirths [ Time Frame: 20 weeks gestation until term ]Defined as all stillbirths/fetal deaths/in utero fetal losses occurring from 20 weeks gestation until term.
- Neonatal Deaths With ≥24 Weeks Gestational Age [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004029