Women’s Health Center of Excellence Research at Ochsner June 2, 2017

CHAP Chronic Hypertension in Pregnancy NIH funded study: 4700 women, 25 hospitals, 5 years Research question: To treat or not treat mild CHTN in pregnancy; conflicting evidence Subjects randomized (1:1) to: Treatment: maintain BP <140/90 using labetalol and/or nifedipine ER Standard: no treatment unless BP increases to ≥160/105 Pragmatic design- similar to routine care Followed through 6 weeks postpartum

Prevena-C Multicenter Trial Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean: a Multicenter Randomized Trial Large NIH funded study- 4 sites, 2850 subjects total Objective: Assess effectiveness, safety, and cost-effectiveness of prophylactic negative pressure wound therapy in reducing rate of surgical site infections after cesareans in obese women Includes both planned and unplanned c/s Patients randomized 1:1 to either: Prevena wound vacuum device Standard bandage dressing

Maternal-Fetal Medicine Units (MFMU) Network National Institute of Child Health and Human Development (NICHD) created Network in 1986 Current network comprised of 14 university based clinical centers and a data coordinating center Ochsner is sub-site to UAB Designed to conduct perinatal studies to improve maternal and fetal outcome with emphasis on randomized controlled trials Current/starting MFMU Network trials: ARRIVE Prospect

ARRIVE A Randomized Trial of Induction Versus Expectant Management Research question: Does elective induction of labor in nulliparous women at 39 weeks improve perinatal outcome compared with expectant management? Design: randomized, controlled study 6000 women- 2 arms Elective induction 39w 0d to 39w 4d Expectant management until 40w 5d+ Followed through 6 weeks postpartum

PROSPECT A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation with a Short Cervix Primary Hypothesis- In women with twin gestation with short cervical length, risk of preterm birth < 35 weeks is reduced with: Arabin cervical pessary Vaginal progesterone Design: 3 groups- pessary, progesterone, placebo drug Randomized after ultrasound shows short cervix Drug/device until 35 weeks Followed through outcome

Blood Draws Studies- Industry Sponsored Sera Prognostics TREETOP study Validation of PreTRM test to predict preterm birth Development of new tests to predict preterm birth Population: Healthy pregnant women <22 weeks Chart review through delivery and postpartum Progenity, Inc. PRO-100 Evaluate screening method for characterizing chromosomal defects, deletions, aberrations in maternal blood Population: Pregnant women at risk for abnormality with CVS or amniocentesis scheduled

Women’s Health Biobank Samples for both in-house and commercial Control patients- urine Pregnant patients- various time points in pregnancy and delivery Blood Amniotic fluid Cord amniotic fluid Placenta Urine Various treatments- frozen, formalin, RNAlater

Problem Pregnancy Exosomes Enroll 50 pregnant women recently diagnosed GDM, preeclampsia, or FGR- 2nd or 3rd trimester 50 matched controls Collect 12ml blood sample (EDTA) & send to UQ for exosome analysis after consent upon admission for delivery morning after delivery Follow outcomes

EGGO Early Gestational Diabetes Screening in Gravid Obese Women Obese pregnant women will be randomized to GDM screening Early 14-18 weeks GA Routine 24-28 weeks GA Outcomes will be ascertained Nothing done in L&D, but may see in clinic Data to be abstracted

PPROM A Randomized Double-Blind Trial Comparing the Impact of 1 vs 2 Courses of Anetnatal Steroids on Neonatal Outcome in Patients with Prelabor Premature Rupture of Membranes Compare 1 vs 2 doses of antenatal corticosteroids in women with expectantly managed PPROM <33weeks GA 2nd blinded course given 7+ days after 1st

AbbVie Elagolix Elagolix- novel, orally administered gonadotropin-releasing hormone antagonist (GnRH Antagonist) Alters level of pituitary GnRH suppression so, titrating circulating estrogen levels are achieved May provide relief from pain associated with endometriosis and uterine fibroids Studied in multiple clinical trials- 2 at Ochsner

Contact information- at Baptist Chris Servay- x73039 and Kate Garvey x-35967 Sherri Longo, MD- CHAP, ARRIVE, PROSPECT, Prevena-C, TREETOP, Progenity-100, exosomes, EGGO, PPROM studies Nicolle Crovetto- x35878 Biobank Donnalee Trapani- x72864 Elagolix studies