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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00422526
Other study ID # 03WH13
Secondary ID
Status Completed
Phase Phase 3
First received January 15, 2007
Last updated January 16, 2007
Start date September 2003
Est. completion date November 2006

Study information

Verified date January 2007
Source King's College Hospital NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Department of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Intervention

Drug:
Micronised progesterone (Utrogestan)


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
King's College Hospital NHS Trust

Countries where clinical trial is conducted

Brazil,  Chile,  Greece,  United Kingdom, 

Outcome

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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