Key Concepts and Procedures StudySpecific Training May 2017 Delivery and Postpartum Schedule of Evaluation 2 When should the Delivery Visit occur Within 3 days after delivery Within 5 days after delivery ID: 625586
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Slide1
Delivery Visits: Key Concepts and Procedures
Study-Specific Training
May 2017Slide2
Delivery and PostpartumSchedule of Evaluation
2Slide3
When should the Delivery Visit occur?
Within 3 days after delivery
Within 5 days after delivery
Within 14 days after deliverySomething else
3
34 of 38Slide4
A mother should still complete the Delivery Visit even if she does not deliver a live born infant.
True
False
4
0 of 38Slide5
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
5
True
False
A mother should still complete the Delivery Visit even if she does not deliver a live born infant.Slide6
Why are Delivery Visits so important?Slide7
Primary study outcomes are ascertained at this visit.
9.2.1
Primary Outcome Measures
9.2.1.1Efficacy
HIV-1 RNA <200 copies/mL at delivery (up to 14 days postpartum), using real-time test results obtained at site laboratories
9.2.1.2
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 7.3.3 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 7.3.3 for severity grading)Slide8
Several secondary study outcomes are ascertained at this visit.
9.2.2
Secondary Outcome Measures
9.2.2.1
HIV-1 RNA <200 copies/mL at delivery (up to 14 days postpartum) using real-time test results obtained at site laboratories
9.2.2.2
HIV-1 RNA <50 copies/mL at
delivery (up to 14 days postpartum)
using batched test results obtained from central
laboratoryHIV-1 RNA <200 copies/mL at 50 weeks postpartum using real-time test results obtained from site laboratories9.2.2.3
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 algorithmSlide9
Several secondary study outcomes are ascertained at this visit.
9.2.2
Secondary Outcome Measures
9.2.2.4
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…]
9.2.2.5
Preterm delivery (<37 completed weeks)
Small for gestational age (<10th percentile using WHO norms)Slide10
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
Delivery Visit Activity