To evaluate whether cervical pessary can replace cervical cerclage in women with previous preterm birth and a short cervix or in women with a history of multiple preterm births in terms of effectiveness and costs
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- delivery before 32 weeks.
Secondary outcome
- delivery before 24 weeks
- delivery before 28 weeks
- delivery before 34 weeks
- delivery before 37 weeks
- time from intervention to delivery
- (early) premature rupture of membranes
- maternal infection
- maternal side effects, i.e. vaginal discharge, bleeding, discomfort,
dyspareunia
- neonatal mortality; i.e. in-hospital death
- neonatal morbidity
Background summary
Preterm birth is a major problem within obstetrics and accounts for the
majority of perinatal morbidity and mortality. When a women had a preterm
delivery the risk of recurrence is increased. According to national guidelines
women with a history of preterm birth are closely monitored with regular visits
to the outpatient clinic and are treated with progesteron. During these
2-weekly prenatal visits the cervical length is measured. In case a cervical
length of 25 millimetres or less is measured, women receive a cerclage. In
women with a history of multiple preterm births a cerclage is offered early in
pregnancy (before 16 weeks) irrespectable of cervical length.
Placing a cercalge is an invasive surgical procedure requiring hospital
admission.
Recent studies have demonstrated that a pessary, a sillicone band folded around
the cervix, is effective in reducing preterm birth in women who have a short
cervical length. This is a non-invasive procedure which takes place at the
outpatient clinic and takes about 10 minutes. This is a patient-friendly
intervention and a much cheaper alternative compared to cerclage. Therefore it
is necessary to asses it's effectiveness in this group of patients.
Hypothesis: we estimate that a pessary is as effective as a cerclage against
lower costs.
Study objective
To evaluate whether cervical pessary can replace cervical cerclage in women
with previous preterm birth and a short cervix or in women with a history of
multiple preterm births in terms of effectiveness and costs
Study design
Nationwide multicentre RCT with an economic analysis alongside it.
Intervention
Pessary versus cerclage inserted for 23+6 weeks of pregnancy
Study burden and risks
In context of this research the burden for patients will be minimal. When
compared to the control group, who receive standard care, burden of the
intervention group is even less, because this group doesn't has to undergo an
invasive procedure.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1. Singleton pregnancy
2. History of preterm birth before 34 weeks of gestation
AND
3. Cervical length of 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
-placenta previa
-vasa previa
-age less than 18 years
-inability to give informed consent
-identified major congenital abnormalities
-Premature Prelabour Rupture of the Membranes (PPROM)
-Cervical dilatation 3cm or more
-Signs of infection or fetal distress
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 |
---|---|
CCMO | NL47362.018.13 |
OMON | NL-OMON26958 |