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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00422526
First Posted: January 17, 2007
Last Update Posted: January 17, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
King's College Hospital NHS Trust
January 15, 2007
January 17, 2007
January 17, 2007
September 2003
Not Provided
Spontaneous delivery before 34 completed weeks (238 days) of gestation.
Same as current
No Changes Posted
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).
Same as current
Not Provided
Not Provided
 
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention
  • Preterm Birth
  • Pregnancy Trimester, Second
Drug: Micronised progesterone (Utrogestan)
Not Provided
Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
November 2006
Not Provided

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.
Sexes Eligible for Study: Female
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil,   Chile,   Greece,   United Kingdom
 
 
NCT00422526
03WH13
Not Provided
Not Provided
Not Provided
Not Provided
King's College Hospital NHS Trust
Not Provided
Principal Investigator: Kypros H Nicolaides, MD, PhD King's College London
King's College Hospital NHS Trust
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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