ArticleVaccine2017
Safety of the oral cholera vaccine in pregnancy: Retrospective findings from a subgroup following mass vaccination campaign in Dhaka, Bangladesh.
Article in Vaccine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01339845 (Introduction of Cholera Vaccine in Bangladesh), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Introduction of Cholera Vaccine in Bangladesh: " Impact Evaluation of Cholera Vaccine and Behaviour Change Interventions in Urban Dhaka"
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- Oral killed cholera vaccines for preventing cholera.The Cochrane database of systematic reviews · 2024Pooled it
- Safety of a bivalent, killed, whole-cell oral cholera vaccine in pregnant women in Bangladesh: evidence from a randomized placebo-controlled trial.BMC infectious diseases · 2019Trial
- Defining and reporting adverse events of special interest in comparative maternal vaccine studies: a systematic review.Vaccine: X · 2024Review
- Controlled Human Infection Models To Accelerate Vaccine Development.Clinical microbiology reviews · 2022Review
- Diagnosis, Management, and Future Control of Cholera.Clinical microbiology reviews · 2022Review
- Maternal vaccination: a review of current evidence and recommendations.American journal of obstetrics and gynecology · 2022Review
- Licensed and Recommended Inactivated Oral CholeraVaccines: From Development to Innovative Deployment.Tropical medicine and infectious disease · 2021Review
- Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response.Vaccine · 2021Review
- Global oral cholera vaccine use, 2013-2018.Vaccine · 2020Review
- The projected impact of geographic targeting of oral cholera vaccination in sub-Saharan Africa: A modeling study.PLoS medicine · 2019Article
- Oral cholera vaccines and their impact on the global burden of disease.Human vaccines & immunotherapeutics · 2019Review
- Cholera.Current epidemiology reports · 2018Article
- Maternal Vaccination as an Essential Component of Life-Course Immunization and Its Contribution to Preventive Neonatology.International journal of environmental research and public health · 2018Review
- Safety of oral cholera vaccines during pregnancy in developing countries.Human vaccines & immunotherapeutics · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPregnant women are vulnerable to complications of cholera. Killed oral cholera vaccines (OCV) are not recommended for pregnant women though there is no evidence of harmful effects during pregnancy. We evaluated the effect of a killed OCV, Shanchol™, on pregnancy outcomes during an effectiveness trial of the vaccine in urban Bangladesh. METHODOLOGY: Individuals ⩾1year were invited to participate in the trial, conducted in 2011 in Dhaka, Bangladesh. Pregnancy by history was an exclusion criterion and all women of reproductive age (15-49years) were verbally questioned about pregnancy at enrollment and prior to vaccination. Out of 48,414 women of reproductive age 286 women received the OCV unknowingly while pregnant. Out of these, we could recruit 69 women defined as exposed to OCV. Accordingly, we selected 69 pregnant women randomly from those who did not take the OCV (non-exposed to OCV). We evaluated adverse pregnancy outcome (spontaneous miscarriages, still births, or congenital malformations) between those who were exposed to OCV and those who were not exposed to OCV.
resultsAbout 16% of pregnant women exposed to OCV had pregnancy loss, as compared to 12% of unvaccinated pregnant women (P=0.38). One congenital anomaly was observed and occurred in women non-exposed to OCV group. Models that adjusted for baseline characteristics that were unbalanced between the exposed and non-exposed groups, revealed a no elevation of risk of adverse pregnancy outcomes in vaccinees versus non-vaccinees (Adj. OR (95% CI): 0.45 (0.11-1.88).
conclusionsNo excess of adverse fetal outcomes associated with receipt of OCV was observed in this study.
trial registrationClinical Trials.gov number NCT01339845.
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Registered trials
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.