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

This study has been completed.
Sponsor:
Information provided by:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT00422526
First received: January 15, 2007
Last updated: January 16, 2007
Last verified: January 2007
  Purpose

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.


Condition Intervention Phase
Preterm Birth
Pregnancy Trimester, Second
Drug: Micronised progesterone (Utrogestan)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Randomised Study to Examine the Effectiveness of Progesterone in Preventing Severe Preterm Delivery

Resource links provided by NLM:


Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • Spontaneous delivery before 34 completed weeks (238 days) of gestation.

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 250
Study Start Date: September 2003
Estimated Study Completion Date: November 2006
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422526

Locations
Brazil
Hospital do Servidor Publico Estadual-FMO
Sao Paulo, Brazil
Chile
Hospital Clinico Universidad de Chile
Santiago, Chile
Greece
University Hospital
Larissa, Greece
United Kingdom
Darent Valley Hospital
Kent, United Kingdom
King's College Hospital NHS Foumdation Trust
London, United Kingdom, SE5 9RS
Queen Elizabeth Hospital, NHS Trust Woolwich
London, United Kingdom, SE18 4QH
University Hospital of Lewisham
London, United Kingdom, SE13 6LH
Southend University Hospital, Essex
London, United Kingdom, SS0 0RY
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
Principal Investigator: Kypros H Nicolaides, MD, PhD King's College London
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00422526     History of Changes
Other Study ID Numbers: 03WH13
Study First Received: January 15, 2007
Last Updated: January 16, 2007
Health Authority: United Kingdom: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by King's College Hospital NHS Trust:
Preterm delivery, short cervix, progesterone

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014