trimethoprim--sulfamethoxazole-drug-combination and Birth-Weight

Antibiotic therapy during pregnancy may be beneficial and impacts positively on the reduction of adverse pregnancy outcomes. No studies have been done so far on the effects of daily Co-trimoxazole (CTX) prophylaxis on birth outcomes. A phase 3b randomized trial was conducted to establish that daily CTX in pregnancy is not inferior to SP intermittent preventive treatment (IPT) in reducing placental malaria; preventing peripheral parasitaemia; preventing perinatal mortality and also improving birth weight. To establish its safety on the offspring by measuring the gestational age and birth weight at delivery, and compare the safety and efficacy profile of CTX to that of SP.. Pregnant women (HIV infected and uninfected) attending antenatal clinic were randomized to receive either daily CTX or sulfadoxine-pyrimethamine as per routine IPT. Safety was assessed using standard and pregnancy specific measurements. Women were followed up monthly until delivery and then with their offspring up to six weeks after delivery.. Data from 346 pregnant women (CTX = 190; SP = 156) and 311 newborns (CTX = 166 and SP = 145) showed that preterm deliveries (CTX 3.6%; SP 3.0%); still births (CTX 3.0%; SP 2.1%), neonatal deaths (CTX 0%; SP 1.4%), and spontaneous abortions (CTX 0.6%; SP 0%) were similar between study arms. The low birth weight rates were 9% for CTX and 13% for SP. There were no birth defects reported. Both drug exposure groups had full term deliveries with similar birth weights (mean of 3.1 Kg). The incidence and severity of AEs in the two groups were comparable.. Exposure to daily CTX in pregnancy may not be associated with particular safety risks in terms of birth outcomes such as preterm deliveries, still births, neonatal deaths and spontaneous abortions compared to SP. However, more data are required on CTX use in pregnant women both among HIV infected and un-infected individuals.. Clinicaltrials.gov NCT00711906.

Topics: Adult; Antimalarials; Birth Weight; Drug Administration Schedule; Female; Gestational Age; HIV Infections; Humans; Malaria; Male; Maternal Exposure; Pregnancy; Pregnancy Complications, Infectious; Pregnancy Complications, Parasitic; Pregnancy Outcome; Treatment Outcome; Trimethoprim, Sulfamethoxazole Drug Combination; Young Adult; Zambia

The effects of cotrimoxazole (CTX) and spiramycin (Spir) in mice infected in midpregnancy with the Beverley (Bev) strain of Toxoplasma gondii were compared. Therapeutic effectiveness was determined according to the following parameters: rate of successful delivery, litter size, offspring weight and survival. When compared with the uninfected untreated control group, CTX showed a more beneficial therapeutic effect than Spir, with a statistically significant increase in the rate of both successful delivery and offspring survival. Results based on antitoxoplasma antibody determinations in the offspring indicated a better in utero control of congenital infection by CTX than by Spir.

Topics: Animals; Antibodies; Birth Weight; Congenital Abnormalities; Delivery, Obstetric; Drug Combinations; Drug Evaluation, Preclinical; Female; Leucomycins; Litter Size; Mice; Pregnancy; Pregnancy Complications, Infectious; Sulfamethoxazole; Toxoplasma; Toxoplasmosis, Animal; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination