Preterm Birth Clinical Trial
Official title:
Randomised Study to Examine the Effectiveness of Progesterone in Preventing Severe Preterm Delivery
The aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on the incidence of severe preterm delivery, defined as delivery before 33+6 weeks in women with a short cervical length of 15mm.
Status | Completed |
Enrollment | 250 |
Est. completion date | November 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All women with singleton or twin pregnancies attending for routine ultrasound examination at 20-25 weeks of gestation with a short cervical length (<15 mm). Exclusion Criteria: - Women with major fetal abnormalities, - Painful regular uterine contractions, or history of ruptured membranes or cervical cerclage in-situ were excluded from screening. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital do Servidor Publico Estadual-FMO | Sao Paulo | |
Chile | Hospital Clinico Universidad de Chile | Santiago | |
Greece | University Hospital | Larissa | |
United Kingdom | Darent Valley Hospital | Kent | |
United Kingdom | King's College Hospital NHS Foumdation Trust | London | |
United Kingdom | Queen Elizabeth Hospital, NHS Trust Woolwich | London | |
United Kingdom | Southend University Hospital, Essex | London | |
United Kingdom | University Hospital of Lewisham | London |
Lead Sponsor | Collaborator |
---|---|
King's College Hospital NHS Trust |
Brazil, Chile, Greece, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spontaneous delivery before 34 completed weeks (238 days) of gestation. | |||
Secondary | 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). |
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