Trial | NCT00536003  Report issue

Title

Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor
Prevention of Preterm Delivery With Vaginal Progesterone in Women With Preterm Labor

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    progesterone ...

  • Study Participants

    384
The administration of vaginal progesterone, in addition to standard tocolysis, will decrease the risk of delivering prematurely and of recurrent preterm labor. We also hypothesize that the reduction in preterm delivery will be associated with a decrease in infant mortality and morbidity.
The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation. Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces infant mortality and morbidity.
Study Started
Jul 31
2006
Primary Completion
Dec 31
2012
Anticipated
Study Completion
Dec 31
2012
Anticipated
Last Update
Jun 06
2012
Estimate

Drug progesterone

vaginal capsules containing 200 mg of natural progesterone, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).

  • Other names: Utrogestan

Drug placebo

vaginal capsules containing placebo, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).

1 Experimental

2 Placebo Comparator

Criteria 

Inclusion Criteria:

Gestational age between 240/7 et 336/7 weeks of gestation (based on a reliable estimate by ultrasound performed before 22 weeks)
Singleton pregnancy
Intact membranes

Preterm labor defined as:

2 or more regular and painful uterine contractions in 10 minutes plus one or plus of the following criteria:
short cervix detected by vaginal ultrasound scanning (cervical length less than 30 mm until 31 weeks and less than 25 mm from 32 weeks)
cervical changes detected clinically (cervical length less or equal 10 mm or Bishop score less than 6
cervical changes during hospitalization (more or equal 5 mm between two clinical or US exams)
positive fetal fibronectin
Age ≥ 18 years old
Signed informed consent
Possible and accepted follow-up

Exclusion Criteria:

Multiple gestation
Cervical cerclage
Hydramnios (AFI >95th percentile for gestational age or greatest pocket >8 cm)
Premature rupture of membranes
Chorioamnionitis (criteria for clinical diagnosis are: elevated WBC, elevated CRP, maternal tachycardia, fetal tachycardia, uterine tenderness and/or amniotic fluid foul odor)
Cervical dilatation > 3 cm
Placenta praevia or abruptio placentae
Intra-uterine growth restriction or non-reassuring fetal status
Pre-eclampsia or severe hypertension
Any other maternal or fetal pathology which should indicate medically preterm delivery
No Results Posted