Suppression of contractions versus no suppression of contractions in the treatment of women giving birth too early.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001007-72-NL

Enrollment

760

Registered

2017-07-06

Start date

2017-07-06

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Neonatal outcome in threatened preterm birth between 30 and 34 weeks of gestation.

Interventions

Trade Name: Atosiban (Tractocile) Product Name: Atosiban Product Code: EMEA/H/C/000253 Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of a

Eligibility

Sex/Gender

All

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 =65 years) no F.1.3.1 Number of subjects for this age range 0

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
Main Objective: The aim of this study is to investigate if tocolysis with atosiban in late preterm birth (30 to 34 weeks) is (cost-) effective compared with placebo in improving neonatal morbidity and mortality.;Secondary Objective: Not applicable.;Primary end point(s): The primary outcome of the study will be a composite adverse perinatal outcome, consisting of bronchopulmonary dysplasia, periventricular leucomalacia > grade 1, intraventricular hemorrhage > grade 2, necrotizing enterocolitis , retinopathy of prematurity > grade 2 or need for laser therapy, proven sepsis and perinatal death. Neonatal outcome will be assessed by neonatologists according definitions in the Dutch perinatal registry. ;Timepoint(s) of evaluation of this end point: Primary and secondary outcome measures will be registered from clinical patient data during hospitalization.	—

Measure

Time frame

Main Objective: The aim of this study is to investigate if tocolysis with atosiban in late preterm birth (30 to 34 weeks) is (cost-) effective compared with placebo in improving neonatal morbidity and mortality.;Secondary Objective: Not applicable.;Primary end point(s): The primary outcome of the study will be a composite adverse perinatal outcome, consisting of bronchopulmonary dysplasia, periventricular leucomalacia > grade 1, intraventricular hemorrhage > grade 2, necrotizing enterocolitis , retinopathy of prematurity > grade 2 or need for laser therapy, proven sepsis and perinatal death. Neonatal outcome will be assessed by neonatologists according definitions in the Dutch perinatal registry. ;Timepoint(s) of evaluation of this end point: Primary and secondary outcome measures will be registered from clinical patient data during hospitalization.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes will be birth within 48 hours, time to delivery, gestational age at delivery, birth weight, number of days on invasive mechanical ventilation, length of admission in NICU, convulsions, asphyxia, meningitis and pneumothorax until 3 months corrected age, maternal infection, maternal side effects and costs. The components of the composite adverse perinatal outcome will also be assessed separately. Maternal side effects are defined as admission to intensive care, anaphylactic shock, dyspnea, hypotension (leading to CTG abnormalities), liver test abnormalities (elevated ASAT or ALAT), and general side effects (nausea, vomiting, headache), post-partum haemorrhage defined as > 500 ml blood loss and maternal mortality. Outcome parameters are in line with the core outcome set for studies on prevention of preterm birth defined by members of GONet and the Core Outcomes in Women’s health (CROWN) initiative (www.crown-initiative.org). ;Timepoint(s) of evaluation of this end point: We will ask informed consent to perform follow-up of the children by standardized questionnaires at 3 month post partum.	—

Measure

Time frame

Secondary end point(s): Secondary outcomes will be birth within 48 hours, time to delivery, gestational age at delivery, birth weight, number of days on invasive mechanical ventilation, length of admission in NICU, convulsions, asphyxia, meningitis and pneumothorax until 3 months corrected age, maternal infection, maternal side effects and costs. The components of the composite adverse perinatal outcome will also be assessed separately. Maternal side effects are defined as admission to intensive care, anaphylactic shock, dyspnea, hypotension (leading to CTG abnormalities), liver test abnormalities (elevated ASAT or ALAT), and general side effects (nausea, vomiting, headache), post-partum haemorrhage defined as > 500 ml blood loss and maternal mortality. Outcome parameters are in line with the core outcome set for studies on prevention of preterm birth defined by members of GONet and the Core Outcomes in Women’s health (CROWN) initiative (www.crown-initiative.org). ;Timepoint(s) of evaluation of this end point: We will ask informed consent to perform follow-up of the children by standardized questionnaires at 3 month post partum.

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Countries

Ireland, Netherlands, United Kingdom

Contacts

Public ContactMartijn Oudijk

Amsterdam UMC location AMC

apostel8@amsterdamumc.nl31205669111

Outcome results

None listed

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