NEWS
SA's women in world's largest HIV study
October 02 2002

By Liz Clarke

The largest study in the world aimed at stemming the numbers of HIV-positive mothers dying of sepsis after the birth of their babies is to be undertaken in KwaZulu-Natal and Transkei.
About 12 000 pregnant mothers will be enrolled in the two-year programme, which, if successful, could prolong the lives of affected mothers worldwide.

The study will be undertaken at two sites - King Edward VIII Hospital in Durban and the Umtata Hospital in the Eastern Cape - and has been made possible by a R2 440 624 grant from pharmaceutical giant Bristol-Myers Squibb under its "Secure the Future" programme.

At a cheque-handing-over ceremony at the University of Natal's Nelson Mandela School of Medicine in Durban on Wednesday, Dr Richard Sebastian Wanless, director of BMS's HIV Research Institute in South Africa and vice-president of the company's bio-ethics division, said after a rigorous process of evaluation, research scientists from KwaZulu-Natal and Transkei were in a position to do the job.
'No large investigations of this nature have ever been done'

"This is a hugely important study," he said. "If the results are what we are hoping for, the impact on children and families will be enormous." Explaining the study process, Dr Jack Moodley, head of the medical school's department of obstetrics and gynaecology, said pregnant women who attended antenatal clinics would be offered the chance of taking a broad-spectrum antibiotic during the birthing process, which would be administered intravenously in a 2-gram dose.

"This will be a randomised double-blind study in which some mothers will be given medication and some not," he said.

"Giving placebos in an HIV-sensitive setting is possible because at this stage we have little indication whether the antibiotic intervention will work, as no large investigations of this nature have ever been done."
An alarming increase in the number of deaths due to postpartum sepsis, and the fact that more maternal deaths were caused by HIV-related disease than any other reason, have prompted the study.

The treatment favoured for the single-dose intervention is Mefoxin, from the cephalosporin class of antibiotics, which is effective against a wide range of anaerobic bacteria (those that tend to form abscesses).
The antibiotic will be delivered during the last stages of labour - but as yet the optimum timing is unclear.

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