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Disproportionate intrauterine growth intervention trial at term (DIGITAT).

Disproportionate 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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23592
Enrollment
600
Registered
2005-09-09
Start date
2005-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disproportionate intrauterine growth retardation at 36 weeks gestational weeks and on

Interventions

Women 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, sonog

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
Under 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

MeasureTime frame
- We will also compare costs. - We aim assessment of the children later in life. Postal enquiries as the CBCL and ASQ will be used

Contacts

Public ContactK. Boers

Leiden University Medical Center (LUMC), Department of Obstetrics, (k6-27), P.O. Box 9600

k.e.boers@lumc.nl+31 (0)71 5262872

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)