To assess the long-term effects of in utero exposure to progesterone or a pessary on child (neuro)development and behaviour at 6 years of corrected age
ID
Source
Brief title
Health condition
Women with short cervical length during mid-trimester, therefore having a highrer risk on preterm birth
Sponsors and support
Intervention
Outcome measures
Primary outcome
Child (neuro)development and behaviour disabilities
Secondary outcome
child mortality, growth and general health
Background summary
Vaginal progesterone and a cervical pessary are both interventions to prevent preterm birth in high risk pregnancies. Thus far, beneficial or harmful effects of these interventions on long-term child health and development are not described, but number of literature is scarce. With this follow-up study, we intent to investigate if progesterone or a pessary is superior for the prevention of preterm birth considering child’s health on the long term. This study is a follow-up study of the Quadruple-P trial; a multicentre, randomised clinical trial (NL42926.018.13, Eudractnumber 2013-002884-24) which randomises women with an asymptomatic midtrimester short cervix to daily progesterone or a pessary for the prevention of preterm birth. All children born to mothers who participated in the Quadruple-P study (n=628 singletons and n=332 multiples) will be eligible for follow-up at 4-6 years of corrected age. Children will be assessed using parental questionnaires. Primary outcomes are child (neuro)development and behavior. Secondary outcomes include child mortality, growth and general health. A composite of adverse child outcome will be compared between progesterone and pessary group reporting odds ratio and the corresponding 95% Confidence Interval. Analyses will be performed by intention to treat.
Study objective
To assess the long-term effects of in utero exposure to progesterone or a pessary on child (neuro)development and behaviour at 6 years of corrected age
Study design
questionnaires will be filled in when children are 4 till 7 years of age
Inclusion criteria
children of women who have participated in the Quadruple-P study
Exclusion criteria
Participants who did not give consent to be approached for follow-up Participants who do not speak Dutch
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL9646 |
| Other | METC AMC : W20_481 # 20.531) |