Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01119963 | Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM) | PHASE2 | COMPLETED | 152 | — | — | Oct 1, 2011 | Oct 1, 2014 | Jun 28, 2018 | 15 | United States |
Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the date the baby was born.
| Arm | Type | Description |
|---|---|---|
| 17-alpha hydroxyprogesterone caproate, Makena® | ACTIVE_COMPARATOR | 250 mg of 17P, Makena® intramuscular (IM) weekly. |
| Placebo | PLACEBO_COMPARATOR | Castor Oil (Placebo)intramuscular (IM) weekly |
| Name | Type | Description |
|---|---|---|
| 17-alpha-hydroxy-progesterone caproate, Makena® | DRUG | Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first. |
| Castor Oil (Placebo) | DRUG | IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first. |
Inclusion Criteria: 1. Participant is 18 years old or older 2. Gestational Age (GA) 23w0d and 30w6d @ time of enrollment 3. Singleton pregnancy 4. PROM defined as either (a) or (b) or (c) below (a) Documentation of vaginal leakage of indigo carmine dye instilled via amniocentesis (b) Positive Amnis...