Pregnancy and Infant Outcomes Among Women Using the Dapivirine Vaginal Ring in Early Pregnancy

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Date
2018Author
Makanani, Bonus
Balkus, Jennifer E.
Jiao, Yuqing
Noguchi, Lisa M.
Palanee-Phillips, Thesla
Mbilizi, Yamikani
Moodley, Jothi
Kintu, Kenneth
Reddy, Krishnaveni
Kabwigu, Samuel
Jeenariain, Nitesha
Harkoo, Ishana
Mgodi, Nyaradzo
Piper, Jeanna
Rees, Helen
Scheckter, Rachel
Beigi, Richard
Baeten, Jared M. ,
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Show full item recordAbstract
Monthly use of the dapivirine vaginal ring has been shown to be safe and effective for HIV-1 prevention in nonpregnant
reproductive-aged women. The impact of dapivirine on pregnancy outcomes and infant is not known. We compared pregnancy incidence and outcomes by study arm among HIV-1–uninfected women who became pregnant while participating in MTN-020/ASPIRE.
ASPIRE was a randomized, double-blind, placebocontrolled phase III safety and effectiveness study of the dapivirinering for HIV-1 prevention. Sexually active women aged 18–45 years from Malawi, South Africa, Uganda, and Zimbabwe were enrolled.
Urine pregnancy tests were performed monthly, and, if positive, study product was withheld during pregnancy and breastfeeding. Pregnancy-related outcomes included the following: pregnancy incidence, pregnancy outcomes (live birth, preterm birth, pregnancy loss, and congenital anomalies), and infant growth.
URI
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6231990/https://nru.uncst.go.ug/xmlui/handle/123456789/1434
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- Medical and Health Sciences [3684]