Phase 2
N=21
Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
Pregnancy Complications
Bottom Line
View on ClinicalTrials.gov: NCT01050647 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Number of Participants With Achievement of 34 Weeks Gestation — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 17-Hydroxyprogesterone Caproate (Drug); Caster Oil injections (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Achievement of 34 Weeks Gestation |
0; 0 | — |
| SECONDARY Number of Participants With Neonatal Respiratory Distress Syndrome |
7; 10 | 0.31 |
| SECONDARY Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage |
1; 2 | >0.99 |
| SECONDARY Number of Participants With Neonatal Necrotizing Enterocolitis |
2; 1 | 0.59 |
| SECONDARY Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days |
39; 50 | 0.16 |
| SECONDARY Length of Latency Assessed as Number of Days |
14.5; 8 | 0.14 |
Summary
Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy in a group of patients in whom this medication has not been previously studied. Specifically, we hope to learn whether progesterone supplementation will delay delivery in women with pre-term, premature rupture of membranes (PPROM).
Eligibility Criteria
Inclusion Criteria
- 18yr of age
- Singleton pregnancy
- PPROM confirmed on clinical exam
- GA between 24+0 and 33+5 wk
- Ability to understand consent in either English or Spanish
Exclusion Criteria
- Contraindication to ongoing pregnancy including:
- Evidence of active infection
- Evidence of significant placental abruption
- IUFD diagnosed at the time of P-PROM diagnosis
- Major fetal malformation
- Maternal allergy to progesterone or placebo drug components
- Current use of progesterone at the time of P-PROM
- Multiple Gestations
- Inability to understand consent in either English or Spanish
Data sourced from ClinicalTrials.gov (NCT01050647). 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.