Atosiban versus placebo in the treatment of late threatened preterm birth (APOSTEL VIII).

Atosiban versus placebo in the treatment of late threatened preterm birth (APOSTEL VIII). - APOSTEL VIII

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54673

Enrollment

745

Registered

2017-06-21

Start date

2017-12-04

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

theatened preterm labour threatened preterm birth

Interventions

Tocolysis with atosiban versus placebo.

Eligibility

Inclusion criteria

Inclusion criteria: Women >= 18 years old with a singleton or twin pregnancy with a gestational age between 30 0/7 and 33 6/7 weeks with threatened preterm birth defined by regular uterine contractions, and one of the following: - Cervical length of

Exclusion criteria

Exclusion criteria: - Previous treatment for threatened preterm birth with corticosteroids in current pregnancy. - Contra indication for tocolysis - Signs of fetal distress - Signs of intra uterine infection - Fetal chromosomal or severe congenital abnormalities

Design outcomes

Primary

Measure	Time frame
The primary outcome is a combined perinatal outcome of severe neonatal morbidity and perinatal mortality.	—

Secondary

Measure	Time frame
Secondary outcome measures include birth	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 5, 2026