The effectiveness of tocolytic agents in the improvement of neonataloutcome in women with threatened preterm labour

• Conditions: Threatened preterm labour; MedDRA version: 14.1Level: LLTClassification code 10056173Term: Threatened premature labour, antepartumSystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2009-015782-30-NL
• Lead Sponsor: Academic Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-26
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

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

Inclusion Criteria

Women with a singleton pregancy with a gestational age of 25-34 weeks in threatened preterm labour, as defined by:
- Uterine contractions, at least 3 contractions per 30 minutes and one of the following:
- Cervical length = 10 mm or
- Cervical length 11 - 30 mm and a positive fibronectine test or
- Ruptured amniotic membranes.
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 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Vaginal bleeding
- Cerclage
- Cervical dilatation > 30 mm
- Previous treatment for preterm contractions
- Hypertension/ anti-hypertensiva
- Myocard infarction (<1 month)
- Unstable angina pectoris

Study & Design

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