A randomised controlled trial of prophylaxis of post-abortal infection: ceftriaxone versus placebo.

OBJECTIVE

To investigate the incidence of post-operative infection after first trimester abortion in women treated with a long-acting cephalosporin (ceftriaxone) compared with low risk patients receiving no treatment and with high risk patients receiving our standard treatment of ampicillin/pivampicillin and metronidazole.

DESIGN

A prospective, randomised controlled trial.

SETTING

Department of Obstetrics and Gynaecology, Rigshospitalet, University of Copenhagen, Denmark.

SUBJECTS

Nine hundred and ninety-six women, admitted on an outpatient basis for legal termination of pregnancy at 12 weeks or less of gestation, were included in the study after giving informed consent. The women were divided into high risk and low risk categories and allocated either to treatment with ceftriaxone or to standard treatment. For high risk patients the standard treatment was initiated by a peroperative injection of ampicillin and metronidazole, followed by oral doses of metronidazole and pivampicillin three times daily for four days. No prophylactic antibiotics were given to the women randomised to standard treatment in the low risk group.

INTERVENTIONS

All women were kept under observation, and, between six and 14 days postoperatively, underwent pelvic examination. Clinical endpoints were noted.

MAIN OUTCOME MEASURES

Post-operative pelvic inflammatory disease in women applying for legal first trimester abortion.

RESULTS

Seven hundred and eighty-six women fulfilled the criteria for evaluation. A tendency toward a prophylactic effect of ceftriaxone was observed in most clinical findings. A significant prophylactic effect of ceftriaxone was found in the low risk group.

CONCLUSIONS

This study demonstrated a significant reduction in post-operative pelvic inflammatory disease in low risk patients, who were applying for legal first trimester abortion, treated peroperatively with ceftriaxone. No significant difference was demonstrated between high risk patients treated with ceftriaxone or ampicillin/pivampicillin and metronidazole.