Now that the ProTwin study has shown an important benefit of pessary use in woman with a short cervix in twin pregnancy, long term follow-up is needed to show that there is no potential harm in using a pessary for preterm delivery prevention. We…
ID
Source
Brief title
Condition
- Other condition
- Neonatal and perinatal conditions
- Cognitive and attention disorders and disturbances
Synonym
Health condition
motorische ontwikkeling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The mean scores on the Bayley (mental and motor) scales. The mean scores of the
Bayley in the general population is 100. A mean score below 92,5 (0,5 Standard
Deviation, SD) is defined as clinically relevant. A sample size of 86 in each
group (n=172) will have 90% power to detect a difference in means of 7,5 (the
difference between a Group 1 mean of 100 and a Group 2 mean of 92,5 assuming
that the common standard deviation is 15 using a two group t-test with a 0,05
two-sided significance level ß of 0.20. This means that a total of 69% should
be reached in the follow-up and only 31% can be missed due to loss to follow-up
or other reasons.
Secondary outcome
The scores in the ASQ, CBCL, general health status and maternal fertility
questionnaires will be evaluated in secundary analyses.
Comparison of the pessary group with the no-pessary group will be performed.
For the ASQ questionnaire an abnormal score is a score of *2SD below the
expected mean of a reference population. For the CBCL questionnaire for each
scale, a strandardized T-score will be calculated. An abnormal T-score is a
score at the >97 percentile. Scores on the general assessment questionnaire
will be used for correction if there are relevant differences on the baseline
characteristics.
Univariate regression analysis will be performed to test the predictive value
of a multiple antepartum variables on the neurodevelopmental and health related
outcomes.
Mortality
Besides developmental outcomes we will register all children who died between
the short term and long term follow-up. The possible difference in percentage
will be tested for significance using Chi-square test.
Background summary
Preterm birth is a major cause of handicaps in genetically normal children
despite the enormous advance in neonatal care during the last decades.
Therefore prevention of preterm birth is the major goal of obstetrical care.
However, strategies to prevent preterm birth have been largely unsuccessful. It
has been suggested that the use of a cervical pessary reduces the risk of
preterm delivery (1;2).
Twin pregnancies are at high risk for preterm birth. In the Netherlands about
50% of the women with a multiple pregnancy deliver before 37 weeks of gestation
and 15% before 34 weeks of gestation (3). At present, about 1 in 60
pregnancies is a twin pregnancy, and about 30% of the preterm born children
admitted in a neonatal care (NICU) are from twin pregnancies (4;5). Due to an
increase in age of pregnant women and an increase in assisted reproductive
technologies the incidence of twin pregnancies is still rising.
The ProTwin study was a Multicenter randomized study investigating the
hypothesis that prophylactic use of a cervical pessary will be effective in the
prevention of preterm delivery and the neonatal mortality and morbidity
resulting from preterm delivery in multiple pregnancy. In conclusion, the
study shows that in women with a multiple pregnancy prophylactic use of a
cervical pessary does not reduce poor perinatal outcome. However, in women with
a relative short cervix at 16-22 weeks, a pessary significantly reduces both
poor perinatal outcome and very preterm birth rates
Study objective
Now that the ProTwin study has shown an important benefit of pessary use in
woman with a short cervix in twin pregnancy, long term follow-up is needed to
show that there is no potential harm in using a pessary for preterm delivery
prevention.
We expect that the ProTwin study is going to have an extended global impact. To
our knowledge there is no long term information on the use of pessary during
pregnancy. Therefore there is a need for long term follow up information.
Study design
A developmental questionnaire called Ages and Stages Questionnaire (ASQ), a
behavioral questionnaire called Child Behavior Checklist (CBCL) and a general
questionnaire concerning the general health status will be used. These tests
will be used as screening tool to see if there is a potential harm using a
pessary on the long term.
A more extended follow-up of the children whose mother had a cervical length of
*38mm (n= 268 children) at three years corrected age. The reason for choosing
this subgroup for a more extended follow-up is because this is the group that
showed a significant positive result on the use of a pessary (mainly on a
different rate of prematurity).
Study burden and risks
The Bayley scales have a positive approach. The tests focus on the abilities
instead of disabilities often experiences as fun by the children and parents.
For the age of 3 years the test will endure approximately 90 minutes. The tests
is safe with no risk of harm, and is used as a standard test in the follow-up
of premature born children at the age of two in the Netherlands. Therefore
there is no need for study-insurance.
Meibergdreef 9
HAARLEM 2033 AL
NL
Meibergdreef 9
HAARLEM 2033 AL
NL
Listed location countries
Age
Inclusion criteria
All patients who were randomized in the ProTwin study (n<=1634 children). A more extended follow-up of all the children whose mother had a cervical length of *38mm will also be performed (n<=268).
Exclusion criteria
None
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 | NL46768.018.13 |