Official Title: “Prevention of Preterm Delivery With Vaginal Progesterone in Women With Preterm Labor”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation
  • Time Frame: end of pregnancy
    Safety Issue?: No

Secondary Measures

• 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 perinatal mortality and morbidity, 4)Side effects
  • Time Frame: end of pregnancy and 28 days after delivery
    Safety Issue?: Yes

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 fibronectin26-28
• 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital, Geneva

Overall Clinical Trial Officials and Contacts

Begona Martinez de Tejada, MD, PhD Principal Investigator University Hospital of Geneva  

Overall Contact: Begona Martinez de Tejada, MD, PhD + 41 22 3826816 begona.mdt@bluewin.ch

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00536003

Study ID Number: CER: 04-196

ClinicalTrials.gov Identifier: NCT00536003

Health Authority: Switzerland: Swissmedic