Dataset Information

Detecting congenital malformations - Lessons learned from the Mpepu study, Botswana.

ABSTRACT:

Introduction

A large and increasing number of HIV-infected women are conceiving on antiretroviral treatment (ART). While most antiretrovirals are considered safe in pregnancy, monitoring for rare pregnancy and infant adverse outcomes is warranted.

Methods

We conducted a retrospective secondary analysis nested within a clinical trial of infant cotrimoxazole vs. placebo prophylaxis in Botswana (the Mpepu Study). Infants were examined at birth, and at least every 3 months through 18 months of age. Abnormal physical findings and diagnostic testing revealing malformations were documented. Post hoc, a geneticist classified all reported malformations based on available documentation. Structural malformations with surgical, medical or cosmetic importance were classified as major malformations. We present a descriptive analysis of identified malformations.

Results

Between 2011 and 2014, 2,933 HIV-infected women who enrolled in the Mpepu study delivered 2,971 live-born infants. Study staff conducted 2,944 (99%) newborn exams. One thousand eighty-eight (38%) women were taking ART at conception; 1,147 (40%) started ART during pregnancy; 442 (15%) received zidovudine monotherapy; and 223 (7%) received no antiretroviral during pregnancy. Of 33 reported anomalies, 25 (76%) met congenital malformations criteria, 10 (30%) were classified as major malformations, 4 (40%) of which were identified after the birth exam.

Discussion

Our results highlight the importance of staff training on identification of congenital malformations, programmatic monitoring beyond the birth examination and the value of geneticist involvement in the malformations classification process in resource-limited settings. These elements will be important to fully define antiretroviral drug safety in pregnancy.

Significance

Surveillance systems for monitoring the safety of antiretroviral use during pregnancy among HIV-infected women in resource-limited setting are lacking. The World Health Organization's published programmatic recommendations for such surveillance systems represents the gold standard. We employed data from a clinical trial in Botswana, a country with a generalized HIV epidemic and high antiretroviral uptake by HIV-infected women, to highlight practical opportunities to strengthen congenital malformation surveillance systems in these settings where over 1 million HIV infected pregnant women reside.

Trial registration

Clinical Trials.gov NCT01229761.

SUBMITTER: Ajibola G

PROVIDER: S-EPMC5365099 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Detecting congenital malformations - Lessons learned from the Mpepu study, Botswana.

Ajibola Gbolahan G Zash Rebecca R Shapiro Roger L RL Batlang Oganne O Botebele Kerapetse K Bennett Kara K Chilisa Florence F Widenfelt Erik von EV Makhema Joseph J Lockman Shahin S Holmes Lewis B LB Powis Kathleen M KM

PloS one 20170324 3

<h4>Introduction</h4>A large and increasing number of HIV-infected women are conceiving on antiretroviral treatment (ART). While most antiretrovirals are considered safe in pregnancy, monitoring for rare pregnancy and infant adverse outcomes is warranted.<h4>Methods</h4>We conducted a retrospective secondary analysis nested within a clinical trial of infant cotrimoxazole vs. placebo prophylaxis in Botswana (the Mpepu Study). Infants were examined at birth, and at least every 3 months through 18 ...[more]

PMID: 28339500

Similar Datasets

Project description:Congenital heart defects (CHD) are structural malformations found at birth with a prevalence of 1%. The clinical trajectory of CHD is highly variable and thus in need of robust diagnostics and therapeutics. Major surgical interventions are often required for most CHDs. In Africa, despite advances in life sciences infrastructure and improving education of medical scholars, the limited clinical data suggest that CHD detection and correction are still not at par with the rest of the world. But the toll and genetics of CHDs in Africa has seldom been systematically investigated. We present an expert review on CHD with lessons learned on Africa. We found variable CHD phenotype prevalence in Africa across countries and populations. There are important gaps and paucity in genomic studies of CHD in African populations. Among the available genomic studies, the key findings in Africa were variants in GATA4 (P193H), MTHFR 677TT, and MTHFR 1298CC that were associated with atrial septal defect, ventricular septal defect (VSD), Tetralogy of Fallot (TOF), and patent ductus arteriosus phenotypes and 22q.11 deletion, which is associated with TOF. There were no data on epigenomic association of CHD in Africa, however, other studies have shown an altered expression of miR-421 and miR-1233-3p to be associated with TOF and hypermethylation of CpG islands in the promoter of SCO2 gene also been associated with TOF and VSD in children with non-syndromic CHD. These findings signal the urgent need to develop and implement genetic and genomic research on CHD to identify the hereditary and genome-environment interactions contributing to CHD. These projected studies would also offer comparisons on CHD pathophysiology between African and other populations worldwide. Genomic research on CHD in Africa should be developed in parallel with next generation technology policy research and responsible innovation frameworks that examine the social and political factors that shape the emergence and societal embedding of new technologies.

Project description:BACKGROUND:In Uruguay it is mandatory to review all cases of positive HIV or reactive syphilis tests in pregnancy and peripartum. We compared the rates of mother-to-child transmission of syphilis and HIV detected by case reviews to those obtained from the usual surveillance system and described the characteristic of vertical transmission cases. METHODS:This is a cross-sectional study performed with secondary data obtained from official government sources, for all the country cases of maternal to child transmission of HIV and syphilis from 2012 to 2017, with descriptive analyses. For congenital syphilis analyses, the following pregnancy characteristics were investigated: number of antenatal checks, gestational age at pregnancy diagnosis, gestational age at syphilis test and diagnosis, adequate treatment, and treatment of partners. Sociodemographic characteristics included type of health care (public/private), maternal age, distribution of ethnic minorities, maximum educational attainment, presence of partner, planned pregnancy, drug and alcohol use, domestic violence, previous maternal diagnosis of syphilis, and previous children with congenital syphilis. RESULTS:Coverage of syphilis case reviews increased from 82% in 2014 to 97.4% in 2017. For HIV, this coverage reached 100% in 2017 and elimination of mother to child transmission was achieved. A marked decline in congenital syphilis was noted in the public health care sector, especially in the capital Montevideo, whereas the private sector has remained below the elimination target. Variables related with congenital syphilis in exposed children were late pregnancy diagnosis, <?5 antenatal checks, delayed diagnosis of gestational syphilis, lower rate of correct treatment for gestational syphilis, untreated partner, low maternal schooling, unplanned pregnancy, history of syphilis, and having other children with syphilis. CONCLUSION:The use of case reviews provided knowledge regarding the accurate number of mother-to-child transmission cases and the evolution of elimination of mother to child transmission in the country. The results suggest that rates must be adjusted, providing an opportunity to improve the reliability of surveillance data, and point the need to address specific gaps in order to improve the quality of care during pregnancy, delivery, and the neonatal period.

Dataset Information

Detecting congenital malformations - Lessons learned from the Mpepu study, Botswana.

Introduction

Methods

Results

Discussion

Significance

Trial registration

Publications

Detecting congenital malformations - Lessons learned from the Mpepu study, Botswana.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure