Objective
We sought to investigate whether oral antibiotics are necessary, after 48 hours of clinical improvement, in uncomplicated septic abortion.
Study design
In a randomized double-blind clinical trial, 56 women with uncomplicated septic abortion were treated with intravenous antibiotics, followed by uterine evacuation. On hospital discharge (day 1), patients were randomized to receive either oral doxycycline plus metronidazole or placebo, until completing 10 days of treatment. Clinical cure was defined by the absence of fever (<37.7°C), reduced vaginal bleeding, and minimal or no pelvic pain.
Results
Cure was observed in all 56 patients. The institutional review board stopped the treatment arm as it was adding risk with no further benefit to the patients. An observational cohort with additional 75 cases was followed up in the no treatment arm and no failure was identified (probability of an adverse event, 0%; 95% confidence interval, 0–0.03).
Conclusion
After 48 hours of clinical improvement, antibiotics may not be necessary.
In the developing world, an estimated 5 million women are admitted to the hospital for treatment of complications from induced abortions each year. This is an average of 5.7 per 1000 women per year in all developing regions, excluding China. In Brazil, abortion is illegal, and because of this, the complications of this procedure represents the third leading cause of maternal mortality and accounts for 12% of the maternal mortality rate. Brazil’s abortion rate is high at 40.8 per 1000 women, and approximately 31% of pregnancies end in an induced abortion.
Patients with established infection, as indicated by fever (arbitrarily defined as >38°C), pelvic peritonitis, or tachycardia, should be hospitalized for parenteral antibiotic therapy and prompt uterine evacuation. Bacteremia, which is more common in septic abortion than in other pelvic infections, may result in septic shock and adult respiratory distress syndrome. The management of severe sepsis requires eradication of the infection, and supportive care for the cardiovascular system and other involved organ systems.
The Brazilian Ministry of Health recommends the use of intravenous clindamycin plus gentamicin for 7-10 days, in cases of uncomplicated septic abortions. Similarly, the World Health Organization (WHO) advises that broad-spectrum intravenous antibiotic therapy should be followed by oral doxycycline (200 mg/d) for 10-14 days. This regimen is similar to that recommended for pelvic inflammatory disease by the Centers for Disease Control and Prevention (CDC).
Contrary to prolonged treatment with oral antibiotics, French and Smaill demonstrated that it is unnecessary to continue antibiotic therapy in postcesarean section endometritis once the patient is afebrile for 48 hours. It could be safe and less expensive to utilize this regimen in cases of uncomplicated septic abortion. There is no evidence thus far to show that this shorter regimen is safe in such cases.
The objective of this is study was to investigate the need for oral antibiotics after 48 hours of clinical improvement, in patients with uncomplicated septic abortion who have undergone uterine evacuation and received a minimum of 48 hours of intravenous antibiotics.
Materials and methods
Participants
Patients admitted to Hospital de Clínicas de Porto Alegre, with a diagnosis of uncomplicated septic abortion, according to the WHO, were eligible for the study. The WHO defines the condition as abortion with the presence of one of the following signs or symptoms: chills or sweats, fever (≥37.8°C), foul-smelling vaginal discharge, abdominal rebound tenderness, hypotension (arterial systolic pressure <90 mm Hg), history of intrauterine manipulation with nonsterile probes, malaise, or pus coming from cervix or mixed with blood in the vagina. We also used the additional criteria of leukocytosis (>14,000 leukocytes/mL) as suggested by Lurie et al.
Patients were treated with intravenous clindamycin 2700 mg, plus gentamicin 240 mg per day and immediate uterine evacuation (day 1). Patients received intravenous antibiotics in the hospital until 48 hours of clinical improvement was noted. Clinical improvement was defined as: no fever, normal leukogram, and a reduction in vaginal bleeding and pelvic pain.
Patients who used antibiotics within 1 week prior to hospitalization, who were not willing to participate, with a diagnosis of tubo-ovarian abscess, or with known allergy to doxycycline or metronidazole were excluded.
Intervention
Before hospital discharge, patients were invited to participate in the study (day 1). Those meeting study criteria and providing consent were randomized to receive either oral doxycycline 100 mg twice daily plus metronidazole 250 mg twice a day, or an identical placebo, until completion of 10 days of treatment (day 10). Medications were prepared by the pharmacy of the Hospital de Clínicas de Porto Alegre, in identical coded blister packets and capsules to assure double blinding. Patients were instructed not to use drugs for pain or fever. They were instructed to return to the hospital if they experienced pain or fever.
Outcome
At 48-72 hours after hospital discharge, patients were contacted by telephone to determine their clinical condition. After finishing the outpatient treatment (day 10), patients were seen by one of the investigators (G.S.M., R.A.C.). Adherence to the study protocol was evaluated by examining the medication packets. At this visit, a standard interview was utilized to identify the presence or absence of the primary outcome (clinical cure). Clinical cure was defined as the absence of fever (<37.8°C), reduced vaginal bleeding, and minimal or no pelvic pain. Clinical failure was defined as hospital readmission, presence of fever (≥37.8°C) after hospital discharge, no reduction of vaginal bleeding, persistence of pelvic pain, or the need to use additional medication (antibiotics or pain medication) whether prescribed or not.
Sample size
Sample size for equivalence was calculated according to Blackwelder, using the formula:
n = ( Z α + Z β ) 2 [ P S ( 1 − P S ) + P T ( 1 − P T ) ] ( P S − P T − d ) 2
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