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

Phase 3

Completed

• Conditions: Preterm Birth; Pregnancy Trimester, Second

• Registration Number: NCT00422526
• Lead Sponsor: King's College Hospital NHS Trust

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2003-09
• Study Completion: 2006-11
• Status Verified: 2007-01
• Study First Submitted: 2007-01-15
• Study First Submitted QC: 2007-01-16
• Last Update Submitted: 2007-01-16
• Study First Posted: 2007-01-17
• Last Update Posted: 2007-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Spontaneous delivery before 34 completed weeks (238 days) of gestation.

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (8)

Hospital Clinico Universidad de Chile; 🇨🇱 Santiago, Chile

University Hospital; 🇬🇷 Larissa, Greece

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

Hospital do Servidor Publico Estadual-FMO; 🇧🇷 Sao Paulo, Brazil

University Hospital of Lewisham; 🇬🇧 London, United Kingdom

Southend University Hospital, Essex; 🇬🇧 London, United Kingdom