Preventing preterm birth: Costs and effects of screening of healthy women with a singleton pregnancy for a short cervical length. - The Triple P study

• Conditions: Preterm birth with healthy singleton pregnancies; MedDRA version: 9.1Level: LLTClassification code 10036600Term: Premature labour

• Registration Number: EUCTR2008-005987-15-NL
• Lead Sponsor: AMC Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

-- Capacitated women
-- = 18 years old
-- Singleton healthy pregnancy
-- Two times a cervical length = 25 mm: a cervical length = 25 mm at 16-20 weeks gestation, and a confirmation of this result with a repeat measurement of the cervical length at 20-22 weeks gestation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Women with a pregnancy with major foetal abnormalities, painful regular uterine contractions, a history of ruptured membranes or a cervical cerclage will be excluded. In addition, women with a previous preterm birth are excluded as well.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified