To evaluate whether a screening program with cervical length measurement to find women at risk for a preterm delivery, is cost-effective. Women with a short cervical length are asked to take part in a follow-up study (the Tripple P treat study) that…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cervical length.
Secondary outcome
Secondary objective is evaluating the cost-effectiveness of screening for
cervical length.
Background summary
Spontaneous preterm delivery is the single most important cause of perinatal
mortality in the Western world. Although it is already known that cervical
length measurement at 20 to 22 weeks can identify women at increased risk for
preterm delivery, an effective treatment has not been available until recently.
In addition, there are no guidelines regarding cut-off values for cervical
length available. In august 2007, Fonseca et al. published in the New England
Journal of Medicine that the risk of preterm delivery in women with a shortened
cervix could be decreased with 50% due to treatment with progesterone. However,
there was no statistically significant effect on neonatal outcome, possibly due
to a lack of statistical power.
Study objective
To evaluate whether a screening program with cervical length measurement to
find women at risk for a preterm delivery, is cost-effective. Women with a
short cervical length are asked to take part in a follow-up study (the Tripple
P treat study) that evaluates whether subsequent progesterone treatment is
effective.
Study design
Multicenter observational cohort study.
Study burden and risks
We don*t expect patients to experience the cervical length measurements as a
burden. Patients exhibiting a short cervical length, have an increased risk of
preterm birth. They will be asked to enter the follow-up clinical trial where
progesterone is administered, which may possibly decrease the preterm birth
rate.
Postbus 22700
1105 DE Amsterdam
NL
Postbus 22700
1105 DE Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- capacitated women
- at least 18 years old
- healthy singleton pregnancy
Exclusion criteria
- major foetal abnormalities
- painful regular uterine contractions
- a history of ruptured membranes
- cervical cerclage
- a previous preterm birth
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL26332.018.08 |