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Clinical Trial Summary

The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone biweekly can reduce the incidence of preterm labor in patients with an episode of threatened preterm labor during the current pregnancy.


Clinical Trial Description

Preterm birth is one of the main causes of neonatal mortality and morbidity around the world, with serious repercussions on the health system and the families of the preterm baby. Many drugs have been evaluated with the purpose of preventing preterm birth in the patient at risk. One of these drugs is 17 α hydroxyprogesterone caproate. The purpose of this study is to evaluate if the use of biweekly doses of 17 α hydroxyprogesterone caproate in patients hospitalized with the diagnosis of threatened preterm labor, defined as the presence of uterine contractions and a short cervix (below the 10th percentile for the gestational age), can reduce the incidence of preterm birth in this high risk group population. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01317225
Study type Interventional
Source Saint Thomas Hospital, Panama
Contact Osvaldo A Reyes, MD (Gyn/Ob)
Phone 011(507)65655041
Email oreyesmaternidad@gmail.com
Status Recruiting
Phase Phase 3
Start date June 2011
Completion date August 2015

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