Trial | NCT01317225  Report issue

Title

Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone
Use of 17α Hydroxyprogesterone Caproate for the Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor During Current Pregnancy. Double Blind, Randomized, Controlled Trial.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
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.
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 Started
Jun 30
2011
Primary Completion
Jul 31
2015
Anticipated
Study Completion
Aug 31
2015
Anticipated
Last Update
Jan 06
2015
Estimate

Drug 17 α hydroxyprogesterone caproate

250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.

Drug Placebo

250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.

  • Other names: Saline solution

17 α hydroxyprogesterone caproate Experimental

17α-Hydroxyprogesterone caproate.

Placebo Placebo Comparator

Saline solution.

Criteria 

Inclusion Criteria:

Pregnant women between 26 and 34 weeks of gestation.
Cervical length (determined by transvaginal ultrasound) below the 10th percentile for the gestational age.

Exclusion Criteria:

Multiple gestations.
Maternal pathologies in which preterm termination of pregnancy is required.
No Results Posted