Twins - timing of birth at term. A randomised clinical trial

ISRCTN	ISRCTN15761056
DOI	https://doi.org/10.1186/ISRCTN15761056
Protocol serial number	N/A
Sponsor	The University of Adelaide (Australia)
Funder	Women's & Children's Hospital (Australia)

Submission date: 18/03/2005
Registration date: 17/06/2005
Last edited: 24/09/2012

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

Prof Caroline Crowther
Scientific

University Department of Obstetrics and Gynaecology
Women's & Children's Hospital
72 King William Road
North Adelaide
5006
Australia

Phone	+61 (0)8 8161 7647
Email	caroline.crowther@adelaide.edu.au

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ACTOTTAB
Study objectives	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.
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	Twins at term
Intervention	Elective birth at 37 weeks gestation compared with standard care
Intervention type	Other
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	576
Key inclusion criteria	Women with a twin pregnancy at 37 weeks gestation
Key exclusion criteria	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.
Date of first enrolment	01/02/2003
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Australia

Study participating centre

University Department of Obstetrics and Gynaecology

North Adelaide
5006
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2012		Yes	No