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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002561-19-AT

Enrollment

Registered

2014-01-23

Start date

2014-03-06

Completion date

Unknown

Last updated

2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature uterine contractions premature labor MedDRA version: 16.1 Level: LLT Classification code 10068718 Term: Premature uterine contractions System Organ Class: 100000004868 MedDRA version: 16.1 Level: LLT Classification code 10036599 Term: Premature labor System Organ Class: 100000004868

Interventions

Trade Name: Tractocile Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ATOSIBAN CAS Number: 90779-69-4 Other descriptive name: Atosiban Concentration unit: mg/ml millig

Eligibility

Sex/Gender

All

Inclusion 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 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

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.

Design outcomes

Primary

Measure	Time frame
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 ;Primary end point(s): Does a long term tocolysis with atosiban lead to a prolongation of pregancy? 1.)Time ( in days) until recurrence of preterm labor with effect on the cervical length during the study period. If 1 is significant: 2.) Time untill delivery during study period. ;Timepoint(s) of evaluation of this end point: recurrence of labor delivery	—

Measure

Time frame

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 ;Primary end point(s): Does a long term tocolysis with atosiban lead to a prolongation of pregancy? 1.)Time ( in days) until recurrence of preterm labor with effect on the cervical length during the study period. If 1 is significant: 2.) Time untill delivery during study period. ;Timepoint(s) of evaluation of this end point: recurrence of labor delivery

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Secondary

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

Measure

Time frame

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

—

Countries

Austria

Contacts

Public ContactStudiensekreteriat Geburtshilfe

Medizinische Universität Wien, Abteilung für Geburtshilfe und Feto-maternale Medizin

00431404002881

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026