Condition category
Pregnancy and Childbirth
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
27/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.studies-obsgyn.nl/digitat/index.asp

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 measures

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

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

http://www.lumc.nl/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Additional files

Editorial Notes