1. Delivery Visits: Key Concepts and Procedures
Study-Specific Training May 2017

2. Delivery and Postpartum Schedule of Evaluation

3. When should the Delivery Visit occur?
Within 3 days after delivery
Within 5 days after delivery
Within 14 days after delivery
Something else
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4. A mother should still complete the Delivery Visit even if she does not deliver a live born infant.
True
False
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5. A mother should still complete the Delivery Visit even if she does not deliver a live born infant.
If the mother is willing to do so, she should complete the Delivery visit and all subsequent postpartum visits, even if she does not deliver a live born infant, or if that live born infant dies soon after delivery
True
False

6. Why are Delivery Visits so important?

7. Primary study outcomes are ascertained at this visit.
9.2.1
Primary Outcome Measures
Efficacy
HIV-1 RNA <200 copies/mL at delivery (up to 14 days postpartum), using real-time test results obtained at site laboratories
Safety
Composite outcome of spontaneous abortion (occurring at <20 weeks gestation), fetal death (occurring at ≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile using WHO norms)
Maternal grade 3 or higher adverse events, including events resulting in death due to any cause, through 50 weeks postpartum (refer to Section for severity grading)
Infant grade 3 or higher adverse events, including events resulting in death due to any cause, through 50 weeks postpartum (refer to Section for severity grading)

8. Several secondary study outcomes are ascertained at this visit.
9.2.2
Secondary Outcome Measures
HIV-1 RNA <200 copies/mL at delivery (up to 14 days postpartum) using real-time test results obtained at site laboratories
HIV-1 RNA <50 copies/mL at delivery (up to 14 days postpartum) using batched test results obtained from central laboratory
HIV-1 RNA <200 copies/mL at 50 weeks postpartum using real-time test results obtained from site laboratories
HIV-1 RNA <200 copies/mL at delivery using real-time test results obtained from site laboratories and FDA snapshot algorithm
HIV-1 RNA <200 copies/mL at 50 weeks postpartum using real-time results obtained from site laboratories and FDA snapshot algorithm

9. Several secondary study outcomes are ascertained at this visit.
9.2.2
Secondary Outcome Measures
Composite outcome of spontaneous abortion (occurring at <20 weeks gestation), fetal death (occurring at ≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile using WHO norms) or major congenital anomaly*
Ranked composite infant safety outcome (defined in Section 9.6.2) through 50 weeks postpartum
Infant HIV infection at delivery and through 50 weeks postpartum
[continues…]
Preterm delivery (<37 completed weeks)
Small for gestational age (<10th percentile using WHO norms)

10. Delivery Visit Activity
Pink cards for mothers, green for infants
Place the cards in the order in which you expect to perform Delivery Visit procedures at your site
Integrate mother and infant procedures where applicable
Omit any cards that are not applicable; add procedures using “other” cards as needed
Note any questions and any procedures for which the protocol is not clear
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