Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr K. Boers
ORCID ID
Contact details
Leiden University Medical Centre
Department of Obstetrics
K6-27
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5262872
k.e.boers@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
DIGITAT
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Multicentre randomised active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/04/2005
Overall trial end date
01/04/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
600
Participant 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
Recruitment start date
01/04/2005
Recruitment end date
01/04/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (Netherlands)
Sponsor details
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17623077
2007 protocol to compare methods of validation: http://www.ncbi.nlm.nih.gov/pubmed/17610715
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/21177352
2013 secondary analysis in: http://www.ncbi.nlm.nih.gov/pubmed/24192662
2014 economic analysis results in: http://www.ncbi.nlm.nih.gov/pubmed/23910171
Publication citations
-
Protocol
Boers KE, Bijlenga D, Mol BW, LeCessie S, Birnie E, van Pampus MG, Stigter RH, Bloemenkamp KW, van Meir CA, van der Post JA, Bekedam DJ, Ribbert LS, Drogtrop AP, van der Salm PC, Huisjes AJ, Willekes C, Roumen FJ, Scheepers HC, de Boer K, Duvekot JJ, Thornton JG, Scherjon SA, Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT., BMC Pregnancy Childbirth, 2007, 7, 12, doi: 10.1186/1471-2393-7-12.
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Protocol to compare methods of validation
Bijlenga D, Birnie E, Mol BW, Bonsel GJ, When outcome is a balance: methods to measure combined utility for the choice between induction of labour and expectant management in mild risk pregnancy at term., BMC Pregnancy Childbirth, 2007, 7, 10, doi: 10.1186/1471-2393-7-10.
-
Results
Boers KE, Vijgen SM, Bijlenga D, van der Post JA, Bekedam DJ, Kwee A, van der Salm PC, van Pampus MG, Spaanderman ME, de Boer K, Duvekot JJ, Bremer HA, Hasaart TH, Delemarre FM, Bloemenkamp KW, van Meir CA, Willekes C, Wijnen EJ, Rijken M, le Cessie S, Roumen FJ, Thornton JG, van Lith JM, Mol BW, Scherjon SA, , Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)., BMJ, 2010, 341, c7087.
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Secondary analysis
Tajik P, van Wyk L, Boers KE, le Cessie S, Zafarmand MH, Roumen F, van der Post JA, Porath M, van Pampus MG, Spaanderdam ME, Kwee A, Duvekot JJ, Bremer HA, Delemarre FM, Bloemenkamp KW, de Groot CJ, Willekes C, van Lith JM, Bossuyt PM, Mol BW, Scherjon SA, , Which intrauterine growth restricted fetuses at term benefit from early labour induction? A secondary analysis of the DIGITAT randomised trial., Eur. J. Obstet. Gynecol. Reprod. Biol., 2014, 172, 20-25, doi: 10.1016/j.ejogrb.2013.10.014.
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Economic analysis results
Vijgen SM, Boers KE, Opmeer BC, Bijlenga D, Bekedam DJ, Bloemenkamp KW, de Boer K, Bremer HA, le Cessie S, Delemarre FM, Duvekot JJ, Hasaart TH, Kwee A, van Lith JM, van Meir CA, van Pampus MG, van der Post JA, Rijken M, Roumen FJ, van der Salm PC, Spaanderman ME, Willekes C, Wijnen EJ, Mol BW, Scherjon SA, Economic analysis comparing induction of labour and expectant management for intrauterine growth restriction at term (DIGITAT trial)., Eur. J. Obstet. Gynecol. Reprod. Biol., 2013, 170, 2, 358-363, doi: 10.1016/j.ejogrb.2013.07.017.