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Capturing primary endpoints under MTN-016 Version 2.0. Lisa Noguchi, CNM, MSN February 24, 2014 Microbicide Trials Network Annual Meeting Bethesda, MD. Protocol. Version 2.0 distributed to sites on 2/14/2014 Updates aims Deletes product-specific language Omits developmental assessment

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capturing primary endpoints under mtn 016 version 2 0

Capturing primary endpoints under MTN-016 Version 2.0

Lisa Noguchi, CNM, MSN

February 24, 2014

Microbicide Trials Network Annual Meeting

Bethesda, MD

protocol
Protocol
  • Version 2.0 distributed to sites on 2/14/2014
    • Updates aims
    • Deletes product-specific language
    • Omits developmental assessment
    • Updates analysis plan
  • Updated site-specific informed consent forms underway
adverse pregnancy outcomes
Adverse pregnancy outcomes
  • Already being collected under Version 1.0 as secondary endpoints
  • Should be capturing these via careful chart review
    • Prenatal record
    • Records from labor ward or operating theatre
    • May also be noted on records from post-natal visit or even baby’s chart
what do we mean by adverse pregnancy outcomes
What do we mean by “adverse pregnancy outcomes”?
  • Delivery <37 completed weeks of gestation
  • Stillbirth or intrauterine demise (≥ 20 weeks)
  • Spontaneous abortion (< 20 weeks)
  • Ectopic pregnancy
  • Intrapartum or postpartum hemorrhage
  • Non-reassuring fetal status
  • Chorioamnionitis
  • Hypertensive disorders of pregnancy
  • Gestational diabetes
  • Intrauterine growth restriction
pointers
Pointers
  • Get help reading any terrible penmanship
  • Ask management team when you’re unsure – clinicians will be happy to help with de-identified records review
  • Know the lingo
    • “Chorioamnionitis”
    • “Sepsis in labour”
    • “Presented with prolonged rupture of membranes, fever and tenderness of the abdomen”
on subjectivity
On subjectivity…
  • Records may be unclear
  • Reduce subjectivity whenever possible
    • Consistency, consistency, consistency
  • Management team needs to deliver consistent guidance on interpreting pregnancy outcomes (e.g., in SSP)
    • If it’s unclear: ASK
  • Sites need to be diligent about consistent reporting
example
Example
  • Patient is a G3 P2 who presented to the ward with term pregnancy in active labour at 11:00. History of anemia but otherwise uncomplicated course. She delivered precipitously in the triage room at 11:14. NSVD of healthy male infant, Apgars 9, 10. EBL 700 mL. Transferred to postnatal unit at 17:30.
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