Details:

Alternative Title:
Reprod Health
Personal Author:
Tinto, Halidou ; Sevene, Esperança ; Dellicour, Stephanie ; Calip, Gregory S. ; d’Alessandro, Umberto ; ... More +
Tinto, Halidou ; Sevene, Esperança ; Dellicour, Stephanie ; Calip, Gregory S. ; d’Alessandro, Umberto ; Macete, Eusébio ; Nakanabo-Diallo, Seydou ; Kazienga, Adama ; Valea, Innocent ; Sorgho, Hermann ; Valá, Anifa ; Augusto, Orvalho ; Ruperez, Maria ; Menendez, Clara ; Ouma, Peter ; Desai, Meghna ; Ter Kuile, Feiko ; Stergachis, Andy Less -
Description:
Background

A major unresolved safety concern for malaria case management is the use of artemisinin combination therapies (ACTs) in the first trimester of pregnancy. There is a need for human data to inform policy makers and treatment guidelines on the safety of artemisinin combination therapies (ACT) when used during early pregnancy.

Methods

The overall goal of this paper is to describe the methods and implementation of a study aimed at developing surveillance systems for identifying exposures to antimalarials during early pregnancy and for monitoring pregnancy outcomes using health and demographic surveillance platforms.

Discussion

Despite few limitations, the methods described here are relevant to the development of sustainable pharmacovigilance systems for drugs used by pregnant women in the tropics using health and demographic surveillance sites to prospectively ascertain drug safety in early pregnancy.

Trial registration

NCT01232530

Electronic supplementary material

The online version of this article (doi:10.1186/s12978-015-0101-0) contains supplementary material, which is available to authorized users.


Subject:
[+]
ACTs
Malaria
Pregnancy
Study Protocol

Source:
Reprod Health. 12.
Pubmed ID:
26637464
Pubmed Central ID:
PMC4670540
Document Type:
Journal Article
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:6234663f805d68cddf6d29450f7983921f3dda409b5e4f1964fe00ff6d38019e
File Type:

Supporting Files

• 	12978_2015_101_MOESM1_ESM.pdf	pdf
  	12978_2015_101_MOESM2_ESM.pdf	pdf
  	12978_2015_Article_101.nxml	bin
  	license.txt	txt

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