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

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ClinicalTrials.gov Identifier: NCT00422526
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : January 17, 2007
Information provided by:
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Randomised Study to Examine the Effectiveness of Progesterone in Preventing Severe Preterm Delivery
Study Start Date : September 2003
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422526

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Hospital do Servidor Publico Estadual-FMO
Sao Paulo, Brazil
Hospital Clinico Universidad de Chile
Santiago, Chile
University Hospital
Larissa, Greece
United Kingdom
Darent Valley Hospital
Kent, United Kingdom
University Hospital of Lewisham
London, United Kingdom, SE13 6LH
Queen Elizabeth Hospital, NHS Trust Woolwich
London, United Kingdom, SE18 4QH
King's College Hospital NHS Foumdation Trust
London, United Kingdom, SE5 9RS
Southend University Hospital, Essex
London, United Kingdom, SS0 0RY
Sponsors and Collaborators
King's College Hospital NHS Trust
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Principal Investigator: Kypros H Nicolaides, MD, PhD King's College London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00422526    
Other Study ID Numbers: 03WH13
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: January 17, 2007
Last Verified: January 2007
Keywords provided by King's College Hospital NHS Trust:
Preterm delivery, short cervix, progesterone
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs