Trial reportPloS one2014
Safety of daily co-trimoxazole in pregnancy in an area of changing malaria epidemiology: a phase 3b randomized controlled clinical trial.
Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00711906 (The Role of Daily Co-trimoxazole Prophylaxis For Prevention of Malaria And Its Effects in Pregnancy), which is not on this map. Cited by 11 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Role of Daily Co-trimoxazole Prophylaxis For Prevention of Malaria And Its Effects in Pregnancy
Who cites it
11 citing papers in PubMed, 4 syntheses or guidelines pooled it, 24 citations in OpenAlex.
- Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women.The Cochrane database of systematic reviews · 2024Pooled it
- Safety of Antimicrobials During Pregnancy: A Systematic Review of Antimicrobials Considered for Treatment and Postexposure Prophylaxis of Plague.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020Pooled it
- Systematic review of statistical methods for safety data in malaria chemoprevention in pregnancy trials.Malaria journal · 2020Pooled it
- Pooled it
- Impact of prophylactic antimalarials in pregnant women living with Human Immunodeficiency Virus on birth outcomes in Botswana.Tropical medicine & international health : TM & IH · 2022Article
- Drugs for Intermittent Preventive Treatment of Malaria in Pregnancy: Current Knowledge and Way Forward.Tropical medicine and infectious disease · 2022Review
- Selected Derivatives of Erythromycin B-Materials (Basel, Switzerland) · 2021Article
- Use of trimethoprim-sulfamethoxazole during pregnancy and risk of spontaneous abortion: a nested case control study.British journal of clinical pharmacology · 2018Article
- Antibiotics in malaria therapy: which antibiotics except tetracyclines and macrolides may be used against malaria?Malaria journal · 2016Review
- Lack of effect of intermittent preventive treatment for malaria in pregnancy and intense drug resistance in western Uganda.Malaria journal · 2015Article
- Effectiveness of antenatal intermittent preventive treatment for malaria with sulphadoxine-pyrimethamine on peripartum outcomes.Therapeutic advances in infectious diseaseArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAntibiotic 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.
methodsPregnant 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.
resultsData 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.
conclusionExposure 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.
trial registrationClinicaltrials.gov NCT00711906.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.