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Clinical Trials and Research

Perinatal clinical trials and research are designed to be able to answer important questions about the care and health of childbearing women and their babies. The goals of these studies are to support a national and international collaborative approach to evidence based health care. Evidence based health care ensures that women and their infants receive the best possible care, based on the best possible evidence.

The Institute of Women’s and Children’s Health at The Townsville Hospital (TTH) collaborates on a number of large-scale, national and international perinatal clinical trials. All clinical trials and research at TTH must be approved, and assigned a protocol number, by The Townsville Heath Service District Ethics Committee. This safeguard ensures that the medical and ethical experts who have evaluated a study believe that the study does not pose any unnecessary or inappropriate risks.

Clinical Trials

 Project Name

 Research Question

 EECV2
Early External Cephalic Version 2 Trial

(Turning baby from breach to head first)

For women with a baby in a breech presentation, does early  External Cephalic Version (ECV) (at 34-35+6 weeks) versus  delayed ECV (not before 37 weeks) increase or decrease the  likelihood of Caesarean Section?
http://www.utoronto.ca/miru/index.htm

FMS
Fetal Movement Study

The Incidence and Management of Reduced Fetal Movements: A Clinical Audit.

Has a woman in your care reported reduced fetal movements? If yes, please remember to complete a Fetal Movement Audit form after the consultation.

Inclusion Criteria: Singleton pregnancies, >28 weeks gestation, every consultaion where reduced fetal movements are reported, either spontaneously by the woman or upon enquiry by the health care provider.

Exclusion Criteria: Women with a multiple pregnancy, consultation by telephone.

 TBS
Twin Birth Study (head first)

For twin pregnancies of 32-38 weeks gestation, where twin A  is presenting vertex, does a policy of planned Caesarean Section  decrease the likelihood of risks, compared to a policy of planned   Vaginal Birth?
 http://www.utoronto.ca/miru/index.htm

 Twins Timing
Timing of birth for women with a twin pregnancy at term – a randomised controlled trial

Can risks for twins be reduced by the elective timing of birth at  37 weeks gestation?
http://www.adelaide.edu.au/health/og/research/mpctu.html#twins

PROGESTERONE

for previous preterm birth for the prevention of neonatal respiratory distress

Does the administration of intravaginal progesterone for women at risk of preterm birth, result in a reducation in the occurrence of preterm birth and its associated sequelae in infants?

PPROMPT
Immediate Delivery Vs Expectant Care In Women With Preterm Pre-labour Rupture Of The Membranes Close To Term  

In women with preterm pre-labour ruptured membranes (PPROM) between 34 wks and 36 weeks gestation is planned early delivery compared with expectant management associated with less neonatal and maternal morbidity?

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If you are invited to participate in a research project or a clinical trial, it is important that you understand your rights and responsibilities.

If you are invited to participate in a research project or a clinical trial, it is important that you understand your rights and responsibilities.

You have the right to full and complete information about what the study means for you personally. This process is known as informed consent.

It is your choice whether or not you want to join a research study. Only you can decide whether joining a trial is right for you or not. If possible you should discuss your participation in the study with your family.
You have the right to withdraw from a research study whenever you want, and for any reason.

You have the right to ask questions about the study, both before it begins and as it continues.

All the data collected is kept confidential and is de-identified thereby protecting your privacy. No identifiable data is published and all records are kept in a secure locked cupboard.

If you are interested in participating in a clinical trial, or would like more information, then please contact Annemarie Lawrence, Research Midwife, The Townsville Hospital. Telephone: 0747961467; or email:

Annemarie_Lawrence@health.qld.gov.au

Relevant Links:
The Cochrane Library

National Health and Medical Research Council

Queensland Health Research and Ethics Management

Clinical Trials and Research, The Townsville Hospital

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Last Updated: 16 July 2007
Last Reviewed: 16 July 2007