The goal of this study is to assess the long-term impact on child*s cognitive- en neurodevelopment, growth and health in children born from mothers with preterm prelabor rupture of membranes (PPROM) between 34 and 37 weeks* gestation.
ID
Source
Brief title
Condition
- Other condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Health condition
Lange termijn ontwikkeling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective: Child*s cognitive development.
Secondary outcome
Secondary outcome: Child*s motor-, academic-, and behavioural development.
Child*s general health (diseases, hospital admissions), child*s growth; as
measured by length, weight, body composition, head circumference, blood
pressure and child*s pulmonary function and respiratory problems.
Background summary
Preterm birth (PTB) is one of the largest single conditions in the Global
Burden of Disease analysis given the high neonatal mortality and the
considerable risk of lifelong impairment. Preterm prelabor rupture of the
membranes (PPROM) complicates approximately 3 percent of pregnancies and leads
to one third of preterm births. The management of PPROM has been debated for a
long time. Recently several randomized controlled trials have been published on
the management of late PPROM, evaluating induction of labour vs. expectant
management. They concluded that in absence of any clear signs of infection or
fetal compromise, a policy of expectant management with appropriate
surveillance of maternal and fetal wellbeing should be followed in pregnant
women who present with ruptured membranes close to term. However, a recent
study performed in our lab shows that, two years after delivery, expectant
management in women with late PPROM might be associated with an increase in
neurodevelopmental difficulties of their offspring at the age of two as
compared to induction of labour.
Study objective
The goal of this study is to assess the long-term impact on child*s cognitive-
en neurodevelopment, growth and health in children born from mothers with
preterm prelabor rupture of membranes (PPROM) between 34 and 37 weeks*
gestation.
Study design
Follow-up of a multicenter randomized controlled trial (PPROMEXIL trial
registered as ISRCTN05689407, PPROMEXIL II approved by the Medical Ethics
Committee of the Maastricht University Medical Center as an amendment of the
PPROMEXIL trial: MEC 05-240). The long-term follow-up of the PPROMEXIL trials
will study the offspring of women with late PPROM during pregnancy who have
been randomized for induction of labour or expected management. Data from this
follow-up study will be coupled to data of the PPROMEXIL and PPROMEXIL-II
study.
In the follow-up of the PPROMEXIL trials women will be asked to fill out four
questionnaires about their children (a general questionnaire, Short Sensory
Profile questionnaire, the Child Behavior Checklist and a questionnaire
regarding respiratory symptoms (ISAAC), such as asthma or other lung problems).
Teachers wil be asked to fill out a questionnaire on school attianment (TRF).
Furthermore, a cognitive- and a neurodevelopment assessment (resp. WISC-V, CWIT
and M-ABC-2) and a physical examination (including the puberty developmental
scale) will be obtained from these children.
Study burden and risks
In order to investigate the long-term effects of the PPROMEXIL trials on
offspring, children born to women who participated in the PPROMEXIL and
PPROMEXIL-II trials will be investigated in a single visit. Patients and their
children will be asked to travel to a local hospital in their neighbourhood.
Assessment of children has a playful approach, is enjoyable for most children
and is not invasive. Participation in this follow-up trial is not associated
with any risks.
Meibergdreef 9
Amsterdam-Zuidoost 1105 AZ
NL
Meibergdreef 9
Amsterdam-Zuidoost 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Singletons born to women who participated in the PPROMEXIL or PPROMEXIL-II trial (PPROMEXIL trial registered as ISRCTN05689407, PPROMEXIL-II approved by the Medical Ethics Committee of the Maastricht University Medical Center as an amendment of the PPROMEXIL trial: MEC 05-240).
Exclusion criteria
None. This is a follow-up study, all singletons included in the PPROMEXIL or PPROMEXIL-II trial can participate.
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 | NL58494.018.16 |