NCT05693688

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
760

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

6.2 years

First QC Date

January 12, 2023

Last Update Submit

July 24, 2024

Conditions

Preterm Birth

Keywords

preterm birththreatened preterm birthpreterm labouratosibanadverse neonatal outcome

Outcome Measures

Primary Outcomes (1)

  • Adverse neonatal outcome

    Combination perinatal mortality and severe neonatal morbidity (BPD, NEC, ROP, IVH, PVL, sepsis,

    Up to 3 months corrected age

Secondary Outcomes (12)

  • Birth within 48 hours

    48 hours

  • Time to delivery

    Not applicible

  • Gestational age at delivery

    At birth

  • Birth weight

    At birth

  • Mechanical ventilation

    Up to 3 months corrected age

  • +7 more secondary outcomes

Other Outcomes (1)

  • Costs

    Up to 3 months corrected age

Study Arms (2)

atosiban

EXPERIMENTAL

Atosiban: bolus injection of 6.75 mg/0.9 ml atosiban in one minute followed by a continuous infusion of 18 mg/hour (=24ml/hour) for 3 hours followed by a continuous infusion of 6 mg/hour (=8 ml/hour) for the remaining 45 hours.

Drug: Atosiban

placebo

PLACEBO COMPARATOR

Placebo: injection of 0.9 ml saline in one minute followed by a saline infusion for 3 hours (24 ml/hour) followed by a continuous infusion (8 ml/hour) for the remaining 45 hours.

Drug: Atosiban

Interventions

AtosibanDRUG

atosiban i.v. administred for 48 hours. The medication will be administered by a bolus injection of 6.75 mg/0.9 mL in 1 min followed by a continuous infusion of 18 mg/hour for 3 hours followed by a continuous infusion of 6 mg/hour for the remaining 45 hours.

Also known as: Tractocile
atosibanplacebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women ≥ 18 years
  • Singleton or twin pregnancy
  • Gestational age between 30 0/7 and 33 6/7 weeks
  • Threatened preterm birth defined by regular uterine contractions, AND one of the following:
  • Cervical length of \< 15 mm OR
  • Cervical length of 15-30 mm and a positive Fibronectine test (≥ 50 ng/mL) OR
  • In case of absence of cervical length measurement in local protocol a positive Fibronectin test or Partus test OR
  • Ruptured amniotic membranes

You may not qualify if:

  • Previous treatment for threatened preterm birth with corticosteroids in current pregnancy
  • Contra indication for tocolysis
  • Signs of fetal distress
  • Signs of intra uterine infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam University Medical Centres, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (1)

  • Klumper J, Breebaart W, Roos C, Naaktgeboren CA, van der Post J, Bosmans J, van Kaam A, Schuit E, Mol BW, Baalman J, McAuliffe F, Thornton J, Kok M, Oudijk MA. Study protocol for a randomised trial for atosiban versus placebo in threatened preterm birth: the APOSTEL 8 study. BMJ Open. 2019 Nov 26;9(11):e029101. doi: 10.1136/bmjopen-2019-029101.

    PMID: 31772083BACKGROUND

Related Links

MeSH Terms

Conditions

Premature BirthObstetric Labor, Premature

Interventions

atosiban

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: International, multicenter, double blinded, placebo controlled RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 23, 2023

Study Start

December 1, 2017

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

July 25, 2024

Record last verified: 2024-07

Locations

NL(1)