No registrations found.
ID
Source
Brief title
Health condition
preterm birth
history of preterm birth
short cervical length
Sponsors and support
Intervention
Outcome measures
Primary outcome
Preterm birth < 32 weeks of gestation
Secondary outcome
Neonatal outcomes
Maternal outcomes
Background summary
Preterm birth (PTB) is in quantity and in severity the most important pregnancy complication in
obstetric care in the developed world. A cervical pessary and a cervical cerclage are both considered
as potential preventive treatments for spontaneous PTB in women at increase risk due to a history
of preterm birth or a short cervical length. This study evaluates the hypothesis that a cervical pessary
is non-inferior to a cervical cerclage in women who are scheduled for cerclage based on their risk
profile for spontaneous PTB.
The study is a nationwide open-label multicenter randomized clinical trial. Eligible women will be
randomized <24weeks in case of previous preterm delivery and short cervical
length to either a cervical pessary or cervical cerclage or before 16 weeks in case a primary cerclage
is required. Both cervical pessary and cervical cerclage will be removed at 36 weeks of GA or until
delivery, whatever comes first.
The primary outcome will be delivery before 32 weeks (<32 weeks). Secondary outcomes will
be preterm rate birth before 24, 28, 34 and 37 weeks, time from intervention to delivery, (early)
premature rupture of membranes, maternal infection, maternal side effects and composite bad
neonatal outcome including both morbidity and mortality rate of children as well as costs.
Study objective
NA
Study design
We will need a run-in period of 3 months for the study set up, and 36 months for inclusion. After inclusion of the last patient, 6 months (additional pregnancy) will be needed for data collection and report of results. The first report on the primary outcome is expected at 4 years after the start of the study.
Intervention
Pessary
Cerclage
Inclusion criteria
1) Singleton pregnancy
2) previous preterm birth < 34 weeks of gestation
AND
3)cervical length < 25mm or less on transvaginal ultrasound before 24 weeks of GA
OR
Indication for primary cerclage before 16 weeks in current pregnancy based on obstetric history, according to local protocol
Exclusion criteria
1) Maternal age less than 18 years
2) Inability to give informed consent
3) Placenta praevia
4) Vasa praevia
5) Premature Prelabour Rupture of the Membranes (PPROM)
6) Cervical dilatation iY3cm
7) Cervical length 2mm
8) Identified major congenital abnormalities.
9) Women with clinical signs of chorioamnionitis or signs of intra uterine infection
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4204 |
| NTR-old | NTR4415 |
| CCMO | NL47362.018.13 |
| OMON | NL-OMON47528 |