Phase 3
N=152
Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)
Preterm Delivery
Bottom Line
View on ClinicalTrials.gov: NCT01119963 ↗Enrolled (actual)
152
Serious AEs
1.7%
Results posted
May 2018
Primary outcome: Primary: Gestational Age at Delivery — 29.2; 29.5 weeks.
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 17-alpha-hydroxy-progesterone caproate, Makena® (Drug); Castor Oil (Placebo) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Obstetrix Medical Group
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gestational Age at Delivery |
29.2; 29.5 | — |
| SECONDARY Duration of Latency Period |
17.1; 17.0 | — |
Summary
The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone caproate (17P, Makena®) given to women with preterm rupture of the membranes will:
1. increase the probability of continuing the pregnancy until a favorable gestational age.
2. increase the interval between randomization and delivery.
3. decrease neonatal morbidity.
Eligibility Criteria
Inclusion Criteria
- Participant is 18 years old or older
- Gestational Age (GA) 23w0d and 30w6d @ time of enrollment
- Singleton pregnancy
- PROM defined as either (a) or (b) or (c) below (a) Documentation of vaginal leakage of indigo carmine dye instilled via amniocentesis (b) Positive Amnisure® test (c) Two or more of (i) through (iv): i. Nitrazine test with pH of 7 or more ii. Positive fern test iii. Gross pooling of clear fluid iv. US exam showing oligohydramnios
Exclusion Criteria
- Any contraindication to expectant management
- Any fetal condition likely to cause serious neonatal morbidity independent of gestational age
- History of allergy to 17P
- Any contraindications to 17P use (e.g. Thrombosis, Breast CA, abnormal vaginal bleeding unrelated to pregnancy, jaundice, liver disease, uncontrolled HTN)
- Any medical condition currently treated with systemic steroid medications
- Cervical cerclage present at the time of PROM
- Informed consent not obtained.
Data sourced from ClinicalTrials.gov (NCT01119963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.