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

2. 2 Maternal Fetal Medicine Units (MFMU) Network Funded in 1986 by NICHD Funded 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 delivery (20/33) preterm delivery (20/33) preeclampsia (4/33) preeclampsia (4/33) management of term labor management of term labor vaginal birth after a prior cesarean vaginal birth after a prior cesarean thrombembolism thrombembolism gestational diabetes gestational diabetes subclinical hypothyroidism subclinical hypothyroidism

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

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

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