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

NCT00422526 | Completed Phase 3

• 1 other identifier: 03WH13
• Study Type: interventional
• Target: 250
• Locations: 4 countries
• Sites: 8

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.

Conditions

Preterm Birth; Pregnancy Trimester, Second

Keywords

Preterm delivery, short cervix, progesterone

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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).

Interventions

Micronised progesterone (Utrogestan) DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Women with major fetal abnormalities,
• Painful regular uterine contractions, or history of ruptured membranes or cervical cerclage in-situ were excluded from screening.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (8)

Hospital do Servidor Publico Estadual-FMO

São Paulo, São Paulo, Brazil

Location

Hospital Clinico Universidad de Chile

Santiago, Santiago Metropolitan, Chile

Location

University Hospital

Larissa, Larissa, Greece

Location

University Hospital of Lewisham

London, London, SE13 6LH, United Kingdom

Location

Queen Elizabeth Hospital, NHS Trust Woolwich

London, London, SE18 4QH, United Kingdom

Location

King's College Hospital NHS Foumdation Trust

London, London, SE5 9RS, United Kingdom

Location

Southend University Hospital, Essex

London, London, SS0 0RY, United Kingdom

Location

Darent Valley Hospital

Kent, United Kingdom

Location

Related Publications (1)

• 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. doi: 10.1056/NEJMoa067815.

  PMID: 17671254 DERIVED

MeSH Terms

Conditions

Premature Birth; Neoplasm Metastasis

Interventions

Utrogestan

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kypros H Nicolaides, MD, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 15, 2007
• First Posted: January 17, 2007
• Study Start: September 1, 2003
• Study Completion: November 1, 2006
• Last Updated: January 17, 2007

Record last verified: 2007-01

Locations

BR (1); CL (1); GR (1); GB (5)