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

January 16, 2007 updated by: King's College Hospital NHS Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Hospital do Servidor Publico Estadual-FMO
  • Chile
      • Santiago, Chile
        • Hospital Clinico Universidad de Chile
  • Greece
      • Larissa, Greece
        • University Hospital
  • United Kingdom
      • Kent, United Kingdom
        • Darent Valley Hospital
      • London, United Kingdom, SE13 6LH
        • University Hospital of Lewisham
      • London, United Kingdom, SE18 4QH
        • Queen Elizabeth Hospital, NHS Trust Woolwich
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foumdation Trust
      • London, United Kingdom, SS0 0RY
        • Southend University Hospital, Essex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Spontaneous delivery before 34 completed weeks (238 days) of gestation.

Secondary Outcome Measures

Outcome Measure
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Investigators

  • Principal Investigator: Kypros H Nicolaides, MD, PhD, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion

November 1, 2006

Study Registration Dates

First Submitted

January 15, 2007

First Submitted That Met QC Criteria

January 16, 2007

First Posted (Estimate)

January 17, 2007

Study Record Updates

Last Update Posted (Estimate)

January 17, 2007

Last Update Submitted That Met QC Criteria

January 16, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03WH13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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