Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial

Preterm Birth Clinical Trial

Official title:

Randomised Study to Examine the Effectiveness of Progesterone in Preventing Severe Preterm Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422526
• Other study ID #: 03WH13
• 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
• 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

Related Conditions & MeSH terms

• Pregnancy Trimester, Second
• Premature Birth
• Preterm Birth

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).