Phase 2 Completed N=21 Randomized Quadruple-blind Treatment

Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.

pregnancy complications

Source: ClinicalTrials.gov NCT01050647 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2018

Primary outcomePrimary: Number of Participants With Achievement of 34 Weeks Gestation — 0; 0 Participants

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).

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.