Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,372
- 试验地点
- 2
- 主要终点
- The primary outcome measure was the development of postpartum infectious morbidity amongst HIV infected versus HIV uninfected pregnant women.
研究概览
简要总结
Postpartum infections are among the leading causes of maternal mortality world-wide, particularly in under-resourced countries. Available data suggests that HIV infected women are at greater risk of postpartum complications than uninfected women. In South Africa, HIV/AIDS and related infections are now cumulatively the leading causes of maternal deaths (though indirectly), with puerperal sepsis among the 5 most common causes.
This was a prospective longitudinal cohort of HIV infected (n = 675) and uninfected (n = 648) women. These were women in whom vaginal delivery was anticipated, and were recruited at > 36 weeks of gestation during the antenatal period.
Hypothesis - HIV infected women are at increased risk of postpartum infectious morbidity and this morbidity can be reduced by use of prophylactic intrapartum antibiotics.
详细描述
INTRODUCTION The World Health Organisation (WHO) estimates that 582 000 women die world-wide each year due to pregnancy related conditions that could be prevented. Most of these deaths occur in developing countries1. Some of the underlying causes of increased maternal morbidity and mortality are HIV-related. In South Africa the antenatal HIV seroprevalence surveys report an infection rate of 32%, the highest among the Sub-Saharan countries2. According to the Saving Mothers Report (NCCEMD) pregnancy-related sepsis was the fourth commonest cause of maternal mortality, while AIDS was the second leading cause3. Of the 67 women who died of HIV/AIDS in 1998, 41 died from puerperal sepsis of which 54% had a vaginal delivery and 46% had a caesarean section. It is not clear from the report to what extent HIV infection had contributed to the severity of sepsis.
The clinical impression is that women with HIV infection have a higher incidence of post delivery morbidity than HIV-negative women. Proposed contributory factors include, low CD4 count and associated impaired immunological function, other obstetric complications and sexually transmitted infections3.
The puerperal sepsis rate is about 2-6 % in most studies. It is however much higher in women with bacterial vaginosis (14%)2 and those who deliver out of health institutions (18%)3. Women with HIV infection are more likely to harbour BV and other sexually transmitted infections. For this and other reasons it is generally accepted that HIV-positive women are at increased risk of puerperal infectious morbidity and mortality independent of the mode of delivery and antiretroviral therapy.
Di Lieto et al4 reported a 33.8 % incidence of infectious morbidity following emergency caesarean delivery. The incidence of infectious morbidity has been reported to be higher in HIV positive women compared to HIV negative women (Semprini et al. 1995)5.
The role of prophylactic antibiotics in obstetric complications has been previously investigated especially in women with preterm labour, prelabour rupture of membranes, cardiac disease and women delivered by caesarean section. There is good evidence that prophylactic antibiotics significantly reduce postpartum morbidity. In these studies prophylactic antibiotics were largely administered intra-operatively. The question that remains is whether prophylactic antibiotics need to be given to only women identified as at risk or to all women with HIV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with a pregnancy of > to 36 weeks of gestation
- •Women with known HIV status as documented by routine rapid HIV tests, following pre-test voluntary counselling and testing (VCT).
- •Women who gave informed study consent.
- •Over the age of 18years
- •Eligible for vaginal delivery
排除标准
- •Women who received antibiotic therapy less than 2 weeks prior to study enrolment.
- •Women planned for elective caesarean delivery.
- •Obstetric complications such as preterm prelabour rupture of membranes, cardiac disease, diabetes and antepartum haemorrhage.
结局指标
主要结局
The primary outcome measure was the development of postpartum infectious morbidity amongst HIV infected versus HIV uninfected pregnant women.
To determine the efficacy of intrapartum prophylactic antibiotics in reducing postpartum infectious morbidity in HIV infected women.
次要结局
未报告次要终点
