To evaluate whether progesterone treatment for women with a short cervical length is effective in reducing the risk of preterm delivery. In addition to assess whether it is cost-effective to do so.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bad neonatal outcome.
Secondary outcome
-- delivery before 34 weeks
-- child health, growth and development at 2 years time to delivery
-- preterm birth rate before 32 weeks, and before 37 weeks
-- days of neonatal admission
-- maternal morbidity
-- maternal admission for preterm labour
-- costs
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 was until recently not 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 progesterone treatment for women with a short cervical
length is effective in reducing the risk of preterm delivery. In addition to
assess whether it is cost-effective to do so.
Study design
Multicenter randomised clinical trial.
Intervention
Vaginal progesterone each night or placebo from 24 to 34 weeks of gestation.
Study burden and risks
A minimal burden for the pregnant woman: from 24 to 34 weeks of gestation daily
1 vaginal capsule.
However, the pregnant woman could benefit a lot from participating in the
trial: if progesterone indeed reduces the preterm birth probability, she does
not have to undergo all problems related to preterm birth.
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
- both measurements of cervical length were < 30 mm (Triple P screening study)
Exclusion criteria
- major foetal abnormalities
- painful regular uterine contractions
- a history of ruptured membranes
- cervical cerclage
- a previous preterm birth
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-005987-15-NL |
| CCMO | NL25467.018.08 |