Condition category
Pregnancy and Childbirth
Date applied
18/03/2005
Date assigned
17/06/2005
Last edited
24/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Caroline Crowther

ORCID ID

Contact details

University Department of Obstetrics and Gynaecology
Women's & Children's Hospital
72 King William Road
North Adelaide
5006
Australia
+61 (0)8 8161 7647
caroline.crowther@adelaide.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ACTOTTAB

Study hypothesis

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

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Twins at term

Intervention

Elective birth at 37 weeks gestation compared with standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/02/2003

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Women with a twin pregnancy at 37 weeks gestation

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

576

Participant 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.

Recruitment start date

01/02/2003

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Australia

Trial participating centre

University Department of Obstetrics and Gynaecology
North Adelaide
5006
Australia

Sponsor information

Organisation

The University of Adelaide (Australia)

Sponsor details

-
Adelaide
SA 5006
Australia
+61 (0)8 81617647
caroline.crowther@adelaide.edu.au

Sponsor type

University/education

Website

http://www.adelaide.edu.au/

Funders

Funder type

Hospital/treatment centre

Funder name

Women's & Children's Hospital (Australia)

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22691051

Publication citations

  1. Results

    Dodd JM, Crowther CA, Haslam RR, Robinson JS, , Elective birth at 37 weeks of gestation versus standard care for women with an uncomplicated twin pregnancy at term: the Twins Timing of Birth Randomised Trial., BJOG, 2012, 119, 8, 964-973, doi: 10.1111/j.1471-0528.2012.03356.x.

Additional files

Editorial Notes