Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)
- Conditions
- Intrauterine Growth FailurePregnancy and Childbirth
- Registration Number
- ISRCTN10363217
- Lead Sponsor
- eiden University Medical Centre (LUMC) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 600
1. Women with a presumed diagnosis of growth failure greater than 36 completed weeks
2. Women are identified initially by clinical assessment of foetal growth between 35 and 39 weeks. After identification, patients will be referred for foetal biometry, a non-stress test and Doppler ultrasound of the umbilical artery and the a. cerebri media
3. Patients in whom the diagnosis of growth failure greater than 36 is confirmed, and in whom the obstetrician is uncertain whether delivery is indicated or not are eligible for the study
4. The final entry criteria are an accurate ultrasound dating scan before 20 weeks and clinical suspicion of failure to thrive in-utero after 36 completed weeks or later, while the clinician is uncertain whether to induce or to await spontaneous delivery
1. Multiple pregnancy
2. Obstetrical history with caesarean section
3. Breech
4. Inaccurate dating of gestational age
5. Suspected congenital malformation
6. Foetal distress needing delivery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method nder the condition of equal short-term neonatal outcome, the primary outcome will be the number of obstetrical interventions. <br><br>Neonatal outcome: <br>1. Umbilical cord pH less than 7.10<br>2. Base Excess less than -10 <br>3. Apgar at 5 minutes less than 7<br>4. Neonatal admittance to Neonatal Intensive Care Unit (NICU)
- Secondary Outcome Measures
Name Time Method 1. Costs<br>2. Assessment of children later in life; postal enquiries as the Child Behavior Checklist (CBCL) and Ages and Stages Questionnaire (ASQ) will be used