Capturing primary endpoints under mtn 016 version 2 0
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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

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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


Revised aims

Revised aims


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


Example po 2 crf

Example: PO-2 CRF


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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