Early

Human

Development,

29 (1992)

313-3

313

15

Elsevier Scientific Publishers Ireland Ltd. EHD 01295

Multicentre collaboration in perinatal trials in Canada J.M. Moutquin and William D. Fraser The Perinatal

Research

Unit, Hdpital

Saint-Fraqois-d’Assise, University, Quebec

Department (Canadn)

of Obstetrics

Gynecology,

Lava1

From a request of the Ministry of Health, the Canadian Association of Professors of Obstetrics and Gynecology and the Medical Research Council played a leadership role in convening perinatal investigators of all 16 university departments. The consensus was reached that the best means to improve the health of Canadians was to treat and/or prevent prematurity. In the last 10 years, several multicentre clinical trials were designed and carried out on perinatal interventions. This multicentre Canadian collaboration has recently evolved in the formation of a permanent perinatal clinical trial network of more than 100 members. Key words: multicentre perinatal trial; clinical trial; clinical trial network; perinatal interventions

Introduction

In the late 197Os, a national conference was held to identify the priority health problems of Canadians. The Ministry of Health requested several agencies including the Medical Research Council of Canada to encourage and support research in health promotion. A question was raised: what could be done to improve the health of Canadians? Among responders, the Association of Professors of Obstetrics and Gynecology, together with the Medical Research Council, played a leadership role by convening three annual workshops. The 16 departments of Obstetrics and Gynecology and Paediatrics, basic researchers interested in fetal or neonatal physiology, and international scientists shared their experience and selected a short list of priority areas needing further research. Correspondence to: J.M. Moutquin, The Perinatal Research Unit, HBpital Saint-Franqois-d’Assise, Department of Obstetrics Gynecology, Lava1 University, Quebec, Canada, GIL 3L5.

0378-3782/92/$05.00 0 1992 Elsevier Scientific Publishers Ireland Ltd. Printed and Published in Ireland

Compare PrednisoneIASA vs. placebo Live births treatment in women with unexplained fetal loss

Toronto

treatment in women with recurrent fetal loss

Treatment failure

Serious Fetal/neonatal infection Postpartum morbidity

Dystocia

VBAC rate

Prednisone/ASA

Toronto

Term premature rupture of the membranes study de Montreal Perineal Management Montreal

Quebec

A multicentre randomized controlled trial of early amniotomy

McGill University/University Trial

Quebec

Randomized trial of prenatal education program on rate of vaginal birth after previous cesarean delivery

Quebec

Prophylactic ind. Cesarean rate Neonatal outcome Pregnancy loss Test accuracy

Mortality and neonatal morbidity

RCT of treatment of chlamydial infection during pregnancy

Toronto

The Canadian multicenlre randomized trial of induction vs. monitoring in post-term pregnancy

Compare effect of Beta adrenergic treatment vs. placebo on perinatal mortality and-neonatal fohow up Compare 2 approaches to management of the post-term pregnancy

Main outcome

Compare CVS to amniocentesis for prenatal diagnosis of chromosomal disorders Compare effect of two approaches to prenatal education for women with previous cesarean section Effect of membrane management on rate of dystocia in nuiliparae Compare effect of induction vs. expectant management in women with Term-prom Compare attempt to avoid episiotomy vs. attempt to avoid tear Compare Amoxicillin vs. Erythromycin in the treatment of genital infection

Quebec

Canadian multicentre randomized controlled trial of the treatment of threatened preterm delivery

Intervention tested

Multicentre randomized clinical trial of chorion villus sampling Winnipeg vs. amniocentesis

Coord. centre

Research

12000 women screened 200 women

1050 mixed parity

2280 patients

925 women

1300 women

2787 pregnancies

3500 women ~41 weeks

708 women 20-35 weeks

Sample size

315

Among these areas, fetal asphyxia and prematurity were selected as priorities to best improve the health of Canadians in the medium term. In 1981, at the final workshop, a consensus was reached that treatment and prevention of prematurity would be the first priority area and that the best approach to addressing this question was to carry out a clinical trial. A planning group was formed to design the first Canadian perinatal clinical trial on treatment of preterm delivery. Members of this group were two obstetricians: P.T. Mohide, J.M. Moutquin; a paediatrician, J.C. Sinclair and a methodologist, R.A. Milner. Careful planning included the site visit of every department of Ob/Gyn and Paediatrics across Canada and then implementation of the trial in some centres. Canadian collaboration experience The ground work carried out by this group together with successful enrolment in a national collaborative trial was a milestone which has facilitated the development of other perinatal trials. In the last ten years, approximately ten national clinical trials have been designed and carried out, generated either by members of the original team or using many of the same centres. The areas of investigation and the current status of these trials is briefly described in the adjoining table. Future prospects: the Canadian perinatal clinical trials network There has been recognition of the need for better coordination and communication in the planning and implementation of multicentre perinatal clinical trials. In June 1991, the Medical Research Council sponsored a workshop which had as its goal the identification of methods to facilitate this process. The workshop brought together representatives from 15 of the 16 departments of Obstetrics and Gynecology across Canada, as well as representatives from the disciplines of Family Medicine, Pediatrics, Neonatology, Epidemiology and Nursing. A decision was taken that there was a need for a permanent perinatal clinical trials network. The establishment of a newsletter was identified as a first priority for the network. Dr. Mary Hannah of the University of Toronto was nominated as editor of this newsletter. A steering committee with both regional and discipline representation was nominated. Dr. William Fraser of Lava1 University is the first chairman of this committee. Its task will be to draft a framework for the functioning of the network. There is a plan to hold annual general meetings of the members of the network. These meetings will serve as a forum to discuss new studies and to assess progress of ongoing studies. Furthermore, the network will interact with other professional organizations with the goal of promoting the integration of research findings into clinical practice.