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The MFMU Network and the MOMS Trial

Elizabeth Thom, PhDThe Biostatistics Center

e_thom@biostat.bsc.gwu.edu301-881-9260

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Maternal Fetal Medicine Units Maternal Fetal Medicine Units (MFMU) Network(MFMU) Network

Funded in 1986 by NICHDFunded in 1986 by NICHD 14 clinical centers 14 clinical centers Biostatistics Center - coordinating center Biostatistics Center - coordinating center 33 studies - sample sizes from 132 – 70,000 33 studies - sample sizes from 132 – 70,000 Topics include Topics include

preterm deliverypreterm delivery (20/33) (20/33) preeclampsia (4/33)preeclampsia (4/33) management of term labormanagement of term labor vaginal birth after a prior cesareanvaginal birth after a prior cesarean thrombembolismthrombembolism gestational diabetesgestational diabetes subclinical hypothyroidismsubclinical hypothyroidism

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Fetal Pulse Oximetry TrialFetal Pulse Oximetry Trial Fetal pulse oximeter - adjunct to electronic Fetal pulse oximeter - adjunct to electronic

fetal heart rate monitoring (EFM) in laborfetal heart rate monitoring (EFM) in labor Supposed to reduce unnecessary cesarean Supposed to reduce unnecessary cesarean

deliveriesdeliveries If fetal heart rate pattern ‘non-reassuring’ can If fetal heart rate pattern ‘non-reassuring’ can

check fetal oxygen statuscheck fetal oxygen status FDA approval in 2000 – based on equivocal FDA approval in 2000 – based on equivocal

trialtrial MFMU Network started trial of EFM alone MFMU Network started trial of EFM alone

versus EFM plus fetal pulse oximeterversus EFM plus fetal pulse oximeter Results: no difference in cesarean delivery rateResults: no difference in cesarean delivery rate

31.0% vs 30.5% 31.0% vs 30.5% Published in NEJM last weekPublished in NEJM last week

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Progesterone TrialProgesterone Trial

17-17-hydroxy-progesterone caproate (17P) hydroxy-progesterone caproate (17P) may be effective in prevention of preterm may be effective in prevention of preterm deliverydelivery

MFMU Network started trial of weekly shots MFMU Network started trial of weekly shots of 17P vs placebo of 17P vs placebo

In women with previous spontaneous In women with previous spontaneous preterm delivery preterm delivery

Reduced preterm delivery by 33%Reduced preterm delivery by 33% significant reduction in births < 32 weekssignificant reduction in births < 32 weeks recently completed follow-up study on infants recently completed follow-up study on infants basis of recommendation by ACOGbasis of recommendation by ACOG

Trial data used for FDA approvalTrial data used for FDA approval panel supportivepanel supportive 17P deemed ‘approvable’17P deemed ‘approvable’

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MOMSMOMS

Prenatal surgery in utero may limit damage Prenatal surgery in utero may limit damage from amniotic fluid exposurefrom amniotic fluid exposure

Trial of prenatal vs postnatal repair of Trial of prenatal vs postnatal repair of myelomeningocele (spina bifida) myelomeningocele (spina bifida)

Funded by NICHD in 2002Funded by NICHD in 2002 Biostatistics Center - coordinating centerBiostatistics Center - coordinating center 3 surgical centers – prenatal surgery not 3 surgical centers – prenatal surgery not

offered elsewhere offered elsewhere Evaluate effect on shunt for hydrocephalus, Evaluate effect on shunt for hydrocephalus,

neuromotor status.neuromotor status. Randomized to prenatal vs postnatal Randomized to prenatal vs postnatal

surgerysurgery Infants followed up at 12, 30 monthsInfants followed up at 12, 30 months