Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)
| ISRCTN | ISRCTN10363217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10363217 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 27/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr K. Boers
Scientific
Scientific
Leiden University Medical Centre
Department of Obstetrics
K6-27
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5262872 |
|---|---|
| k.e.boers@lumc.nl |
Study information
| Study design | Multicentre randomised active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | DIGITAT |
| Study objectives | Early induction of labour being an effective intervention e.g. for the prevention of neonatal neurologic morbidity for foetus with established disproportionate intrauterine growth retardation. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Intrauterine Growth Failure |
| Intervention | Women will be randomly allocated to induction of delivery (intervention group) or expectant monitoring group (expectant group). Foetal condition will be assessed using foetal 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 obstetrician's 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 foetal condition or maternal condition requires a clear indication for this develops. They will be observed according to local practice until labour starts spontaneously. Foetal monitoring will be according to local practice. However, the minimal monitoring will include a weekly measurement of the umbilical artery Doppler waveform. |
| Intervention type | Other |
| Primary outcome measure | Under the condition of equal short-term neonatal outcome, the primary outcome will be the number of obstetrical interventions. Neonatal outcome: 1. Umbilical cord pH less than 7.10 2. Base Excess less than -10 3. Apgar at 5 minutes less than 7 4. Neonatal admittance to Neonatal Intensive Care Unit (NICU) |
| Secondary outcome measures | 1. Costs 2. Assessment of children later in life; postal enquiries as the Child Behavior Checklist (CBCL) and Ages and Stages Questionnaire (ASQ) will be used |
| Overall study start date | 01/04/2005 |
| Completion date | 01/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 600 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 01/04/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
University/education
University/education
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/ |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Research organisation
The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol to compare methods of validation: | 04/07/2007 | Yes | No | |
| Protocol article | protocol | 10/07/2007 | Yes | No | |
| Results article | results | 21/12/2010 | Yes | No | |
| Results article | economic analysis results | 01/10/2013 | Yes | No | |
| Other publications | secondary analysis | 01/01/2014 | Yes | No |
