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.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is a combined perinatal outcome of severe neonatal
morbidity and perinatal mortality.
Secondary outcome
Secondary outcome measures include birth <48 hours, time to delivery,
gestational age at birth, admission to the Neonatal Intensive Care Unit (NICU),
total number of days alive outside the hospital counted from 37 weeks gestation
until corrected age of three months, maternal morbidity, adverse effects and
cost.
Background summary
Theatened preterm birth complicates 20,000 pregnancies annually in the
Netherlands. Tocolysis is historically a part of the treatment, but the
effectiveness of the treatment has never been proven. The WHO has recently
stated that the use of tocolytica should be reconsidered.
Study 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.
Study design
Multicenter randomized placebo-controlled clinical trial with a
cost-effectiveness analysis.
Intervention
Tocolysis with atosiban versus placebo.
Study burden and risks
The burden is very low as well as the risks involved.
Meibergdraaf 9
Amsterdam 1105 AZ
NL
Meibergdraaf 9
Amsterdam 1105 AZ
NL
Listed location countries
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 <= 15 mm or
- Cervical length of 15-30 mm and a positive fFn test or in case of absence of
cervical length measurement in local protocol a positive Fibronectin test or
Partus test
- Ruptured amniotic membranes
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-001007-72-NL |
| CCMO | NL61439.018.17 |
| OMON | NL-OMON25764 |