Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT
<p>Abstract</p> <p>Background</p> <p>Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2007-07-01
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| Series: | BMC Pregnancy and Childbirth |
| Online Access: | http://www.biomedcentral.com/1471-2393/7/12 |
| _version_ | 1819117644146540544 |
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| author | Huisjes Anjoke JM van der Salm Paulien CM Drogtrop Addie P Ribbert Lucy SM Bekedam Dick J van der Post Joris AM van Meir Claudia A Bloemenkamp Kitty WM Stigter Rob H van Pampus Marielle G Birnie Erwin LeCessie Saskia Mol Ben WJ Bijlenga Denise Boers Kim E Willekes Christine Roumen Frans JME Scheepers Hubertina CJ de Boer Karin Duvekot Johannes J Thornton Jim G Scherjon Sicco A |
| author_facet | Huisjes Anjoke JM van der Salm Paulien CM Drogtrop Addie P Ribbert Lucy SM Bekedam Dick J van der Post Joris AM van Meir Claudia A Bloemenkamp Kitty WM Stigter Rob H van Pampus Marielle G Birnie Erwin LeCessie Saskia Mol Ben WJ Bijlenga Denise Boers Kim E Willekes Christine Roumen Frans JME Scheepers Hubertina CJ de Boer Karin Duvekot Johannes J Thornton Jim G Scherjon Sicco A |
| author_sort | Huisjes Anjoke JM |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term.</p> <p>Methods/design</p> <p>The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ). Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term). The study aims to include 325 patients per arm.</p> <p>Discussion</p> <p>This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term.</p> <p>Trial registration</p> <p>Dutch Trial Register and ISRCTN-Register: ISRCTN10363217.</p> |
| first_indexed | 2024-12-22T05:36:15Z |
| format | Article |
| id | doaj.art-3c9e49224d2048378700902385919257 |
| institution | Directory Open Access Journal |
| issn | 1471-2393 |
| language | English |
| last_indexed | 2024-12-22T05:36:15Z |
| publishDate | 2007-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pregnancy and Childbirth |
| spelling | doaj.art-3c9e49224d20483787009023859192572022-12-21T18:37:18ZengBMCBMC Pregnancy and Childbirth1471-23932007-07-01711210.1186/1471-2393-7-12Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITATHuisjes Anjoke JMvan der Salm Paulien CMDrogtrop Addie PRibbert Lucy SMBekedam Dick Jvan der Post Joris AMvan Meir Claudia ABloemenkamp Kitty WMStigter Rob Hvan Pampus Marielle GBirnie ErwinLeCessie SaskiaMol Ben WJBijlenga DeniseBoers Kim EWillekes ChristineRoumen Frans JMEScheepers Hubertina CJde Boer KarinDuvekot Johannes JThornton Jim GScherjon Sicco A<p>Abstract</p> <p>Background</p> <p>Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term.</p> <p>Methods/design</p> <p>The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ). Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term). The study aims to include 325 patients per arm.</p> <p>Discussion</p> <p>This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term.</p> <p>Trial registration</p> <p>Dutch Trial Register and ISRCTN-Register: ISRCTN10363217.</p>http://www.biomedcentral.com/1471-2393/7/12 |
| spellingShingle | Huisjes Anjoke JM van der Salm Paulien CM Drogtrop Addie P Ribbert Lucy SM Bekedam Dick J van der Post Joris AM van Meir Claudia A Bloemenkamp Kitty WM Stigter Rob H van Pampus Marielle G Birnie Erwin LeCessie Saskia Mol Ben WJ Bijlenga Denise Boers Kim E Willekes Christine Roumen Frans JME Scheepers Hubertina CJ de Boer Karin Duvekot Johannes J Thornton Jim G Scherjon Sicco A Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT BMC Pregnancy and Childbirth |
| title | Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT |
| title_full | Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT |
| title_fullStr | Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT |
| title_full_unstemmed | Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT |
| title_short | Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT |
| title_sort | disproportionate intrauterine growth intervention trial at term digitat |
| url | http://www.biomedcentral.com/1471-2393/7/12 |
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