Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
|Preterm Birth Pregnancy Trimester, Second||Drug: Micronised progesterone (Utrogestan)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Prevention
|Official Title:||Randomised Study to Examine the Effectiveness of Progesterone in Preventing Severe Preterm Delivery|
- Spontaneous delivery before 34 completed weeks (238 days) of gestation.
- Birth weight, fetal or neonatal death, major adverse outcome before discharge from hospital and need for neonatal special care (admission to special care baby unit, phototherapy, treatment of proven or suspected sepsis, or blood transfusion).
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||November 2006|
BACKGROUND The results of randomized studies have shown that the prophylactic use of progesterone in women who previously delivered prematurely reduces the risk of recurrence. Asymptomatic women found to have a short cervix (< 15 mm) at mid-gestation are at greatly increased risk for spontaneous early preterm delivery and it is uncertain whether in such women the risk is reduced by progesterone.
METHODS Cervical length was measured by transvaginal sonography at 22 (range 20-25) weeks in 24,620 pregnant women attending for routine antenatal care. The cervix was 15 mm or less in 413 (1.7%), and 250 (60.5%) of these women participated in a randomized study of vaginal progesterone (200 mg per night) vs identical-looking placebo, between 24 and 34 weeks. Primary outcome was the frequency of spontaneous delivery before 34 weeks (238 days) of pregnancy. Analysis was performed according to the intention-to-treat principle.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422526
|Hospital do Servidor Publico Estadual-FMO|
|Sao Paulo, Brazil|
|Hospital Clinico Universidad de Chile|
|Darent Valley Hospital|
|Kent, United Kingdom|
|University Hospital of Lewisham|
|London, United Kingdom, SE13 6LH|
|Queen Elizabeth Hospital, NHS Trust Woolwich|
|London, United Kingdom, SE18 4QH|
|King's College Hospital NHS Foumdation Trust|
|London, United Kingdom, SE5 9RS|
|Southend University Hospital, Essex|
|London, United Kingdom, SS0 0RY|
|Principal Investigator:||Kypros H Nicolaides, MD, PhD||King's College London|