EUCTR2013-002561-19-AT
Active, not recruiting
Phase 1
A prospective, double blind, randomised, placebo controlled trial to evaluate the effect of a long term tokolysis with atosiban on the pregnancy outcome. A pilot study. - Long term tokolysis with atosiban
Medizinische Universität Wien, Univ.Klinik f.Frauenheilkunde,Abt. f.Geburtshilfe und Feto-maternale Medizin0 sites60 target enrollmentJanuary 23, 2014
ConditionsPremature uterine contractionspremature laborMedDRA version: 16.1Level: LLTClassification code 10068718Term: Premature uterine contractionsSystem Organ Class: 100000004868MedDRA version: 16.1Level: LLTClassification code 10036599Term: Premature laborSystem Organ Class: 100000004868Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
DrugsTractocile
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Premature uterine contractionspremature labor
- Sponsor
- Medizinische Universität Wien, Univ.Klinik f.Frauenheilkunde,Abt. f.Geburtshilfe und Feto-maternale Medizin
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •intact singleton pregnancy between 23\+0 and 28\+0 weeks gestation
- •intact membranes
- •cervical length \= 15mm
- •immediate previous completion of standard tocolysis with atosiban for 48 hours
- •Able to communicate well with the investigator, to understand and comply with the requirements of the study
- •Signed the written informed consent
- •women over 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •rupture of membranes
- •Amnion infection syndrome, fever (\>38°C)
- •vaginal bleeding with intensity of menstruation or above
- •placenta praevia
- •polyhydramnion
- •congenital malformations, deformations and chromosomal abnormalities
- •preexistant Diabetes Typ I or II
- •multiple pregnancies
- •Prolaps of membranes till the external cervical os.
Outcomes
Primary Outcomes
Not specified
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