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Disproportionate intrauterine growth intervention trial at term (DIGITAT).


- candidate number1482
- NTR NumberNTR287
- ISRCTNISRCTN10363217
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitleDisproportionate intrauterine growth intervention trial at term (DIGITAT).
- Scientific TitleDisproportionate intrauterine growth intervention trial at term to assess costs and effects of induction of labour versus expectant management in women with an expected small for gestational babie at term.
- ACRONYMDIGITAT
- hypothesisEarly induction of labour being an effective intervention e.g. for the prevention of neonatal neurologic morbidity for fetus with established disproportionate intauterine growth retardation.
- Healt Condition(s) or Problem(s) studiedFetal growth retardation, Intrauterine growth
- Inclusion criteria1. Women with a presumed diagnosis of growth failure > 36 completed weeks;
2. Women are identified initially by clinical assessment of fetal growth between 35 and 39 weeks. After identification, patients will be referred for fetal 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 > 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.
- Exclusion criteria1. Multiple pregnancy;
2. Obstrtical history with caesarean section;
3. Breech;
4. Inacurate dating of gestational age;
5. Suspected congenital malformation;
6. Fetal distress needing delivery.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-apr-2005
- planned closingdate1-apr-2008
- Target number of participants600
- InterventionsWomen will be randomly allocated to induction of delivery (intervention group) or expectant monitoring group (expectant group).
Fetal condition will be assessed using fetal heart rate pattern, sonographic measurement of amniotic fluid index, and Doppler measurement of the a. umbilicalis and a. cerebri media.
If women are allocated to intervention, labour will be induced within 48 hours after randomisation. The method of induction will be at the obstetricianís discretion. Cervical ripening with prostaglandins, osmotic cervical dilatation or digital sweeping of the membranes is optional.
The use and timing of amionotomy and the timing and use of oxytocine regime (if used) will all follow local practice.
Participants allocated to this group will not have labour induced unless the fetal condition or maternal condition requires a clear indication for this develops. They will be observed according to local practice until labour starts spontaneously.
Fetal monitoring will be according to local practice. However, the minimal monitoring will include a weekly measurement of the umbilical artery Doppler waveform.
- Primary outcomeUnder the condition of equal short term neonatal outcome, the primary outcome will be the number of obstetrical interventions.
,strong> Neonatal outcome:
- Umbilical cord pH< 7.10
- Base Excess < -10 Apgar 5 min. < 7
- Neonatal admittance to NICU
- Secondary outcome- We will also compare costs.
- We aim assessment of the children later in life. Postal enquiries as the CBCL and ASQ will be used
- Timepoints
- Trial web sitehttp://www.studies-obsgyn.nl/digitat/index.asp
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. K. Boers
- CONTACT for SCIENTIFIC QUERIESDr. MD. PhD. S.A. Scherjon
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publicationsvan den Hove MM, Willekes C, Roumen FJ, Scherjon SA. Intrauterine growth restriction at term: Induction or spontaneous labour? Disproportionate intrauterine growth intervention trial at term (DIGITAT): A pilot study.Eur J Obstet Gynecol Reprod Biol. 2005 Jul 26
- Brief summaryPROBLEM:
Small babies with evidence of growth failure, born at term are at increased risk of neurodevelopmental abnormalities, ranging from behavioural problems, minor developmental delay to spastic cerebral palsy.
There is little evidence that these abnormalities originate from acute birth asphyxia; they could be related to antenatal factors. In the systematic review literature no reference is made to early induction of labour being an effective intervention e.g. for the prevention of neonatal neurologic morbidity.
However, early induction might possibly result in more obstetrical interventions, maternal morbidity, a poorer neonatal outcome and higher costs could be possible.
AIM:
To assess costs and effects of induction of labour versus expectant monitoring in women with small for gestational babies at term.
PATIENTS:
In six perinatal centres, patients will be included with a presumed diagnosis of growth failure > 36 completed weeks.
INTERVENTION:
Fetal condition will be assessed using fetal heart rate pattern, sonographic measurement of amniotic fluid index, and Doppler measurement of the a. umbilicalis and a. cerebri media.
Subsequently, women will be randomly allocated to induction of delivery (intervention group) or expectant monitoring group (expectant group).
OUTCOME:
Under the condition of equal short term neonatal outcome, the primary outcome will be the number of obstetrical interventions. We will also compare costs.
We aim assessment of the children later in life, but for these long-term outcomes no funding is asked in the present proposal.
ANALYSIS:
We will compare costs and effects of induction of labour in women with a presumed diagnosis of growth failure. We will evaluate which diagnostic tests are helpful in the antenatal assessment of these patients.
- Main changes (audit trail)
- RECORD12-sep-2005 - 7-mrt-2006


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