Antimicrobial prophylaxis in pregnancy: A randomized, placebo-controlled trial with cefetamet-pivoxil in pregnant women with a poor obstetric history☆,☆☆,★,★★

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Abstract

Objective: This study was undertaken to measure the impact of a single oral dose of cefetamet-pivoxil on pregnancy outcome in a population with substantial rates of low birth weight and high prevalence rates of maternal infections. Study design: A total of 320 pregnant women with a poor obstetric history, defined as a history of low birth weight or stillbirth, were randomized to receive a single oral dose of 2 gm of cefetamet-pivoxil or a placebo at a gestational age between 28 and 32 weeks. Patients were assessed at delivery and 1 week post partum for pregnancy outcome, postpartum endometritis, human immunodeficiency virus-1 and gonococcal infections. Results: A total of 253 (79%) women gave birth at the maternity hospital, of whom 210 (83%) attended the follow-up clinic. Overall, 18.1% of these pregnant women were human immunodeficiency virus-1 seropositive, whereas 9.5% had antibodies against Treponema pallidum. There was a significant difference between cefetamet-pivoxil– and placebo-treated women in infant birth weight (2927 gm vs 2772 gm, p = 0.03) and low birth weight (<2500 gm) rates (18.7% vs 32.8%, p = 0.01, odds ratio 2.1, 95% confidence interval 1.2 to 3.8). The stillbirth rate was 2.2% in the cefetamet-pivoxil group and 4.2% in the placebo group (not significant). Postpartum endometritis was found in 17.3% in the intervention arm versus 31.6% in the placebo group (p = 0.03, odds ratio 2.2, 95% confidence interval 1.1 to 7.6). Neisseria gonorrhoeae was isolated from the cervix in 5 of 103 (4.9%) women in the intervention and in 14 of 101 (13.9%) in the placebo group (p = 0.04, odds ratio 3.2, 95% confidence interval 1.1 to 10.5). Conclusion: A single oral dose of cefetamet-pivoxil administered to pregnant women with a poor obstetric history seemed to improve pregnancy outcome in this population with high rates of maternal infections. Larger studies should be carried out to examine the public health impact, the feasibility, and the overall cost/benefit ratio of this intervention.

Section snippets

Patients and methods

Women with a poor obstetric history attending the mother-child health clinic of Pumwani Maternity Hospital in Nairobi, Kenya, were invited to participate in the study at a gestational age of 28 to 32 weeks. Poor obstetric history was defined as a history of preterm birth (<37 weeks), LBW (<2500 gm), stillbirth, or early perinatal mortality. Stillbirth and early neonatal mortality were included because a large proportion of perinatal mortality was the result of prematurity, but mothers often did

Results

Between November 1995 and February 1996, 320 pregnant women were enrolled in the study, 160 in the cefetamet-pivoxil group and 160 in the placebo arm. No women refused to participate. The first antenatal visit was around 24 weeks of pregnancy. The two groups were comparable with regard to age, marital status, parity, and obstetric history (variables listed in Table I). The mean gestational age, based on the LMP and clinical estimates, at enrollment was 30 weeks. Eighty-three percent of patients

Comment

Our data suggest an effect of a broad-spectrum antibiotic treatment during pregnancy on the infant's birth weight. In a population with high rates of sexually transmitted diseases antenatal case detection and treatment of gonorrhea and other sexually transmitted diseases during pregnancy is the obvious solution to this problem but there are major logistic impediments to its implementation. Diagnostic algorithms for cervical infection, on the basis of clinical signs and symptoms or on behavioral

Acknowledgements

We thank Dr. Louis Haller from the Roche African Research Foundation, Abidjan, Ivory Coast, for helpful discussions and useful comments.

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From the World Health Organization Centre for Research and Training in Sexually Transmitted Diseases, Department of Medical Microbiology, University of Nairobi,a and the Department of Obstetrics and Gynaecology, University of Ghent.b

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Supported by the International Centre for Reproductive Health, University of Ghent, Ghent, Belgium, and the Roche African Research Foundation, Abidjan, Ivory Coast.

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Reprint requests: Marleen Temmerman, MD, PhD, International Centre for Reproductive Health, University Hospital Ghent, De Pintelaan 185, 9000 Ghent, Belgium.

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0002-9378/97 $5.00 + 0 6/1/83056

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