Twins - timing of birth at term. A randomised clinical trial
| ISRCTN | ISRCTN15761056 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15761056 |
| Secondary identifying numbers | N/A |
- 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
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 |
|---|---|
| caroline.crowther@adelaide.edu.au |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| 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 | 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). |
| Secondary outcome measures | 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 |
| Overall study start date | 01/02/2003 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
5006
Australia
Sponsor information
The University of Adelaide (Australia)
University/education
University/education
-
Adelaide
SA 5006
Australia
| Phone | +61 (0)8 81617647 |
|---|---|
| caroline.crowther@adelaide.edu.au | |
| Website | http://www.adelaide.edu.au/ |
"ROR" |
https://ror.org/00892tw58 |
Funders
Funder type
Hospital/treatment centre
Women's & Children's Hospital (Australia)
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? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2012 | Yes | No |
