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ISRCTN
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ISRCTN15761056
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ClinicalTrials.gov identifier
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Public title
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Twins - timing of birth at term. A randomised clinical trial
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Scientific title
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Acronym
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ACTOTTAB
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Serial number at source
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N/A
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Study hypothesis
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The primary hypothesis of the trial is that for women with a twin pregnancy elective timing of birth at 37 weeks gestation is associated with a reduction in serious adverse outcome for the infant, defined as one or more of stillbirth, neonatal death or significant infant morbidity.
Please note that, as of 28/08/2009, the anticipated start and end dates of this trial have been updated from 01/05/2005 and 31/08/2008 to 01/02/2003 and 31/12/2010, respectively.
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Lay summary
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Ethics approval
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Approval for the lead centre was obtained from the Women's & Children's Hospital Research Ethics Committee (ref: EC00197). All other centres have obtained ethics approval before recruitment of the first participant.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Twins at term
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Participants - inclusion criteria
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Women with a twin pregnancy at 37 weeks gestation
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Participants - exclusion criteria
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Women with any of the following will be excluded from the trial: intrauterine fetal death of one or both fetuses at the time of trial entry; active labour; fetal distress or non-reassuring fetal heart rate trace; maternal or fetal compromise precluding continued antenatal surveillance.
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Anticipated start date
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01/02/2003
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Anticipated end date
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31/12/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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576
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Interventions
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Elective birth at 37 weeks gestation compared with standard care
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Primary outcome measure(s)
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A composite mortality and morbidity index has been chosen as the primary outcome for the trial.
For a policy of elective birth at 37 weeks gestation to be justified in clinical practice, there must be an important benefit of reduced perinatal mortality or serious adverse outcome for the infants defined as one or more of the following occurring within six weeks postpartum:
1. Perinatal mortality defined as any fetal death after trial entry, or death of a liveborn infant within 28 days of age (excluding lethal congenital anomalies); or
2. Serious neonatal morbidity defined as one or more of the following, excluding lethal congenital anomalies: birth trauma (subdural or intracerebral haemorrhage, spinal cord injury, basal skull fracture, other fracture, peripheral nerve injury present at discharge from hospital); birth weight <3rd centile for gestational age at birth and infant sex (Roberts 1999); Apgar score <4 at 5 minutes of age; cord pH <7.18; base deficit (arterial or venous cord blood) >-8; seizures at <24 hours age or requiring two or more drugs to control; neonatal encephalopathy grade 3 or 4 (Sarnat 1976); altered level of consciousness (stupor, decreased response to pain or coma); use of ventilation >24 hours; use of tube feeding >4 days; admission to neonatal intensive care unit (NICU) >4 days; severe respiratory distress syndrome (mean arterial pressure [MAP] >10 and or FiO2 >0.8 with need for ventilation); proven necrotising enterocolitis; proven systemic infection within 48 hours of birth treated with antibiotics.
These definitions of adverse outcome are those used by the Australian and New Zealand Neonatal Network (Donoghue 2000), and those considered by experts as important measures of term and post-term neonatal morbidity (Hannah 1992).
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Secondary outcome measure(s)
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1. Antenatal medical and obstetric defined complications
2. Labour and birth defined complications
3. Adverse outcomes for the infant defined
4. Serious adverse outcome for the woman defined as a composite endpoint of birth
5. Maternal physical wellbeing
6. Maternal emotional wellbeing
7. Maternal satisfaction with care
8. Longer term health, growth and development of the infant
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Sources of funding
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Women's & Children's Hospital (Australia)
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Trial website
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Publications
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Contact name
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Prof
Caroline
Crowther
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Address
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University Department of Obstetrics and Gynaecology
Women's & Children's Hospital
72 King William Road
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City/town
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North Adelaide
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Zip/Postcode
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5006
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Country
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Australia
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Tel
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+61 (0)8 8161 7647
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Fax
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+61 (0)8 8161 7652
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Email
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caroline.crowther@adelaide.edu.au
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Sponsor
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The University of Adelaide (Australia)
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Address
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-
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City/town
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Adelaide
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Zip/Postcode
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SA 5006
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Country
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Australia
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Tel
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+61 (0)8 81617647
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Fax
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+61 (0)8 8161 7652
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Email
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caroline.crowther@adelaide.edu.au
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Sponsor website:
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http://www.adelaide.edu.au/
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Date applied
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18/03/2005
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Last edited
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28/08/2009
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Date ISRCTN assigned
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17/06/2005
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