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The MFMU Network and the MOMS Trial

The MFMU Network and the MOMS Trial. Elizabeth Thom, PhD The Biostatistics Center e_thom@biostat.bsc.gwu.edu 301-881-9260. Maternal Fetal Medicine Units (MFMU) Network. Funded in 1986 by NICHD 14 clinical centers Biostatistics Center - coordinating center

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The MFMU Network and the MOMS Trial

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  1. The MFMU Network and the MOMS Trial Elizabeth Thom, PhD The Biostatistics Center e_thom@biostat.bsc.gwu.edu 301-881-9260

  2. Maternal Fetal Medicine Units (MFMU) Network • Funded in 1986 by NICHD • 14 clinical centers • Biostatistics Center - coordinating center • 33 studies - sample sizes from 132 – 70,000 • Topics include • preterm delivery (20/33) • preeclampsia (4/33) • management of term labor • vaginal birth after a prior cesarean • thrombembolism • gestational diabetes • subclinical hypothyroidism

  3. Fetal Pulse Oximetry Trial • Fetal pulse oximeter - adjunct to electronic fetal heart rate monitoring (EFM) in labor • Supposed to reduce unnecessary cesarean deliveries • If fetal heart rate pattern ‘non-reassuring’ can check fetal oxygen status • FDA approval in 2000 – based on equivocal trial • MFMU Network started trial of EFM alone versus EFM plus fetal pulse oximeter • Results: no difference in cesarean delivery rate • 31.0% vs 30.5% • Published in NEJM last week

  4. Progesterone Trial • 17-ahydroxy-progesterone caproate (17P) may be effective in prevention of preterm delivery • MFMU Network started trial of weekly shots of 17P vs placebo • In women with previous spontaneous preterm delivery • Reduced preterm delivery by 33% • significant reduction in births < 32 weeks • recently completed follow-up study on infants • basis of recommendation by ACOG • Trial data used for FDA approval • panel supportive • 17P deemed ‘approvable’

  5. MOMS • Prenatal surgery in utero may limit damage from amniotic fluid exposure • Trial of prenatal vs postnatal repair of myelomeningocele (spina bifida) • Funded by NICHD in 2002 • Biostatistics Center - coordinating center • 3 surgical centers – prenatal surgery not offered elsewhere • Evaluate effect on shunt for hydrocephalus, neuromotor status. • Randomized to prenatal vs postnatal surgery • Infants followed up at 12, 30 months

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