Measuring Adverse Pregnancy and Newborn Congenital Outcomes

MI-összefoglaló

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A vizsgálat olyan várandós nőket keres, HIV-fertőzéssel vagy anélkül, akik a vizsgálati helyen terhesgondozásban vesznek részt, valamint a babáikat. A helyszínen történt összes szülés adatait is gyűjtik.

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Csak nők.

A részvétel fő kizáró okai

• Olyan nők, akiknek testi vagy szellemi fogyatékossága megakadályozza, hogy beleegyezésüket adják

A regiszter feltételei, szó szerint

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The purpose of this study is to develop a pharmacovigilance (PV) surveillance program to monitor adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).

A vizsgálat 3 csoportja

• Cohort 1 (C1)

  Prospective recruitment of pregnant women enrolling in antenatal clinic (ANC) at the site. All HIV+ pregnant women and a 1:1 systematic sample of HIV- pregnant women enrolling in ANC at the site will be prospectively enrolled. In addition, medical record data for the mother and infant will be collected at the time of delivery for all women who deliver at the site and as such will contribute to a subset of C2 (below). Women enrolled in C1 who do not deliver at the site will be contacted by phone and through field follow-up to ascertain their pregnancy and infant outcomes. Infants born to women enrolled in this component who are suspected of having congenital abnormalities (CAs) will be enrolled as outlined in C3 (below) if their mothers deliver at the site. If their mothers do not deliver at the site these infants will be enrolled in the field. Photos/videos of infants with CAs will also be taken for review and classification by a panel of experts (see C3 below).

  Kezelés: Pharmacovigilance surveillance program

• Cohort 2 (C2)

  Cross-sectional data collection for deliveries at the site. Data will be collected retrospectively from medical records for all women who deliver at the site (including the women enrolled in C1 above), as well from the medical records of all newborn infants and stillbirths delivered at the site. Missing or incomplete information in the woman or her infant's medical record will be clarified by contacting the woman to provide this information.

  Kezelés: Pharmacovigilance surveillance program

• Cohort 3 (C3)

  Photos/videos of infants with CAs. All newborn infants and stillbirths ≥ 24 weeks gestational age delivered at the site, as well as all infants born to women enrolled in C1, will be assessed by surface exam for the presence of CAs. Video and photographs will be taken of CAs identified on surface exam. These images will be reviewed and classified by panel of experts in genetics, dysmorphology and teratology. Mothers of infants with major CAs will be contacted by phone at 1, 6, and 12 months post-delivery to ascertain their infants' vital status and care engagement status.

  Kezelés: Pharmacovigilance surveillance program