Does a long term tokolysis with atosiban provide any benefit for the pregnancy outcome, compared to the standard short term tokolysis?

Phase 1

Conditions: Premature uterine contractionspremature labor
MedDRA version: 16.1Level: LLTClassification code 10068718Term: Premature uterine contractionsSystem Organ Class: 100000004868
MedDRA version: 16.1Level: LLTClassification code 10036599Term: Premature laborSystem Organ Class: 100000004868
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2013-002561-19-AT

Lead Sponsor: Medizinische Universität Wien, Univ.Klinik f.Frauenheilkunde,Abt. f.Geburtshilfe und Feto-maternale Medizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 60

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
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of long term tocolysis with atosiban on the pregency outcome. (Gestational age at delivery);Secondary Objective: Prolongation of pregnancy, time intervall til recurrant preterm labor, cervical length/shortening of the cervix, drop out rate <br>;Primary end point(s): Does a long term tocolysis with atosiban lead to a prolongation of<br>pregancy?<br><br>1.)Time ( in days) until recurrence of preterm labor with effect on the cervical length during the study period.<br><br><br>If 1 is significant: <br>2.) Time untill delivery during study period.<br>;Timepoint(s) of evaluation of this end point: recurrence of labor <br>delivery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): gestational age at birth<br><br>Time period (days) after long term tocolysis ( after the end of the study period) until birth<br><br>time period (days) after routine tocolysis (48hrs) until birth.<br><br>Time period (days) after the study period until recurrence of preterm labor with effect on the cervical length.<br><br>need for another tocolysis cycle after the study period until SSW 33+6.<br><br>Delivery before gestational age 28+0, 30+0, 33+6<br><br> Perinatal Mortality<br><br> Perinatal Morbidity- Perinatal Morbidity composite index<br><br>Side effects of the therapy (study period) ;Timepoint(s) of evaluation of this end point: recurrence of preterm labor and delivery