ong term outcomes following a pessary placement to pregnant woman with a multiple pregnancy: 3 year follow-up of the ProTwin trial
Completed
- Conditions
- motorische ontwikkelingMental and Psychomotor development1002892010009841
- Registration Number
- NL-OMON40439
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1634
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The mean scores on the Bayley (mental and motor) scales. The mean scores of the<br /><br>Bayley in the general population is 100. A mean score below 92,5 (0,5 Standard<br /><br>Deviation, SD) is defined as clinically relevant. A sample size of 86 in each<br /><br>group (n=172) will have 90% power to detect a difference in means of 7,5 (the<br /><br>difference between a Group 1 mean of 100 and a Group 2 mean of 92,5 assuming<br /><br>that the common standard deviation is 15 using a two group t-test with a 0,05<br /><br>two-sided significance level ß of 0.20. This means that a total of 69% should<br /><br>be reached in the follow-up and only 31% can be missed due to loss to follow-up<br /><br>or other reasons.</p><br>
- Secondary Outcome Measures
Name Time Method