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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. 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

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  1. Capturing primary endpoints under MTN-016 Version 2.0 Lisa Noguchi, CNM, MSN February 24, 2014 Microbicide Trials Network Annual Meeting Bethesda, MD

  2. 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

  3. Revised aims

  4. 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

  5. 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

  6. Example: PO-2 CRF

  7. 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”

  8. 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

  9. 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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