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Review
. 2020 Jun 11;14(6):e0008140.
doi: 10.1371/journal.pntd.0008140. eCollection 2020 Jun.

Inclusion of women susceptible to and becoming pregnant in preregistration clinical trials in low- and middle-income countries: A proposal for neglected tropical diseases

Monique Couderc-Pétry  1 , Elisabeth Eléfant  2 , Monique Wasunna  3 , Alwyn Mwinga  4 , Nilima A Kshirsagar  5 , Nathalie Strub-Wourgaft  6
Affiliations
Review

Inclusion of women susceptible to and becoming pregnant in preregistration clinical trials in low- and middle-income countries: A proposal for neglected tropical diseases

Monique Couderc-Pétry et al. PLoS Negl Trop Dis. .
No abstract available

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. WoSuP inclusion in clinical trials, with availability of safe effective contraception a negative pregnancy test at inclusion, pregnancy test repeated at each visit, and access to safe abortion.
“Safe or nonserious, manageable (toxicology data) effects” indicates not life-threatening, no major disability: for example, supernumerary ribs. “Unsafe, serious (toxicology data) effects” indicates life-threatening or invalidating: for example, cardiac, cleft lip, or neural tube defect. “Life-threatening disease” indicates immediate or rapid death: for example, serious malaria access. “Chronic, invalidating disease” indicates important impact on daily activities: for example, leishmaniasis. “Effective contraception” indicates accessible, suitable, and well-accepted, effective contraception. “No inclusion” indicates formal contra-indication to include WoSuP. “Avoid inclusion” indicates inclusion restricted to where no available treatment alternative. “Possible inclusion” indicates inclusion after balanced evaluation of pros and cons. “Postpone inclusion” indicates inclusion after the end of pregnancy. “Recommended inclusion” indicates encourage inclusion of WoSuP to increase the chance of treatment or cure. “Inclusion” indicates same risks from participation in the trial for WoSuP as for other populations. P, Phase.
Fig 2
Fig 2. Continuation of clinical trials in women who are unexpectedly detected or become pregnant after inclusion.
P, Phase.
See this image and copyright information in PMC

References

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