Nav: Home

Evaluation of recombinant antithrombin vs. placebo in preterm preeclampsia

January 23, 2017

LAS VEGAS (Jan. 23, 2017)--In a study to be presented Friday, Jan. 27, in the late breaking oral session at 10 a.m. PST, at the Society for Maternal-Fetal Medicine's annual meeting, The Pregnancy Meeting™, researchers with The PRESERVE-1 Study Group University of Texas Health Science Center at Houston--McGovern Medical School, Houston, Texas, and Yale School of Medicine, New Haven, Connecticut, present findings of a study titled Randomized double-blind placebo controlled evaluation of the safety and efficacy of recombinant Antithrombin versus placebo in preterm preeclampsia. The study was sponsored by rEVO Biologics, Inc.

Preeclampsia is a major cause of maternal and perinatal mortality and morbidity. In addition, women who develop early onset preeclampsia have markedly increased rate of complications both acute and long term such as cardiovascular disease, stroke, renal injury and metabolic syndrome. Infants born at less than 30 weeks have significant neonatal complications with prolonged stays in the neonatal intensive care unit. In addition, they are at increased risk for chronic lung disease, cerebral palsy and other neurologic deficits. There are approximately 8,000 cases of early onset preeclampsia each year in the U.S. The estimated maternal and neonatal cost of these pregnancies is almost $1.5 billion.

This trial investigated the effects of recombinant antithrombin (ATryn®), a man-made version of antithrombin, a protein molecule found in blood that is produced by the liver, regulates the coagulation system, and has anti-inflammatory properties. It was studied to determine its potential to prolong gestation and improve maternal and neonatal outcomes. The study's design was remarkable in that it was the largest randomized, controlled trial ever to be completed in patients who developed preeclampsia very early in pregnancy, 23-30 weeks' gestational age.

Baha Sibai, M.D. with the University of Texas Health Science Center at Houston and the presenter of the study at the SMFM annual meeting, reported "The results found no improvement in outcomes with such therapy. There were no reported safety events related to Recombinant Antithrombin" Future studies should investigate different novel targeted therapies to improve outcome in such pregnancies."
-end-
A copy of the abstract is available at http://www.smfmnewsroom.org and below. For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell).

About the Society for Maternal-Fetal Medicine

The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine. The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed. For more information visit http://www.smfm.org.

Abstract LB02 Randomized double-blind placebo controlled evaluation of the safety and efficacy of recombinant Antithrombin versus placebo in preterm preeclampsia Baha Sibai¹ , Michael J. Paidas² , The PRESERVE Study Group ¹University of Texas Health Science Center at Houston - McGovern Medical School, Houston, TX, ²Yale School of Medicine, New Haven, CT

OBJECTIVE: Antithrombin's (AT) anti-inflammatory and anticoagulant properties along with prior clinical evidence support AT as a potential therapy for preeclampsia (PreE). We studied recombinant AT (rhAT) in a multi-center study to determine if rhAT could extend the duration of pregnancy and decrease neonatal morbidity in expectantly managed patients with early onset PreE.

STUDY DESIGN: We performed a double-blind, placebo controlled trial at 23 tertiary hospitals. Women were eligible if they had a singleton pregnancy, early onset PreE/superimposed PreE at 23 0/7 to 30 0/7 wks, and deemed stable for expectant management. Antihypertensives, magnesium sulfate and steroids were used as indicated. Patients were randomized 1:1 to receive either rhAT 250 mg loading dose followed by a continuous infusion 2000mg/24hours or an identical saline infusion. The infusion was continued until delivery. Specific predefined outcomes of interest were assessed in both mother and neonate (through 36 weeks post menstrual age). The primary efficacy endpoint was median increase in gestational age (GA) from randomization until delivery. The secondary efficacy endpoint was a composite neonatal outcome score (Image 1). Safety was assessed through laboratory and adverse event review. A sample size of 120 was required.

RESULTS: 120 were randomized: 62 rhAT and 58 placebo. There were no differences between groups in median GA at enrollment (27.6 vs 27.3 for placebo vs rhAT respectively), demographics, or rate of superimposed PreE. Mean baseline % AT activity was similar between groups and much higher than anticipated (93% vs 95% for placebo vs rhAT respectively). There were no differences between groups in primary outcome or composite neonatal score (Table). Results remained the same in pre-specified subgroups: GA at enrollment (<27 vs> 27), PreE vs superimposed PreE. Finally, there were no significant differences in maternal complications such as pulmonary edema, eclampsia, or HELLP syndrome. There were no reported safety events related to rhAT.

CONCLUSION: Administration of rhAT in early onset PreE was not associated with pregnancy prolongation nor improved maternal/ neonatal outcomes.

Society for Maternal-Fetal Medicine

Related Pregnancy Articles:

Paracetamol during pregnancy can inhibit masculinity
Paracetamol during pregnancy can inhibit masculinity Paracetamol during pregnancy can inhibit the development of 'male behavior' in mice.
The cost of opioid use during pregnancy
A new study published today by the scientific journal Addiction reveals that the incidence of neonatal abstinence syndrome -- often caused by mothers using opioids during pregnancy -- is increasing in the United States, and carries an enormous burden in terms of hospital days and costs.
New study: Pre-pregnancy BMI directly linked to excess pregnancy weight gain
It's well known that excessive weight gain during pregnancy can have a lasting negative impact on the health of a mother and her baby.
Pregnancy-specific β1-glycoproteins
Development of new strategies and novel drug design to treat trophoblastic diseases and to provide pregnancy success are of crucial importance in maintenance the female reproductive health.
Should hypothyroidism in pregnancy be treated?
When a woman becomes pregnant, many changes occur in her body.
Pre-pregnancy progesterone helps women with recurrent pregnancy loss
Women who have had two or more unexplained miscarriages can benefit from natural progesterone treatment before pregnancy, a new a study from the University of Illinois at Chicago shows.
Male pipefish pregnancy, it's complicated
In the upside-down world of the pipefish, sexual selection appears to work in reverse, with flashy females battling for males who bear the pregnancy and carry their young to term in their brood pouch.
Pregnancy leads to changes in the mother's brain
A study directed by researchers from the UAB and IMIM are the first to reveal how pregnancy causes long-lasting alterations in brain structure, probably related to improving the mother's ability to protect and interact with the child.
MRIs during pregnancy and outcomes for infants, children
In an analysis that included more than 1.4 million births, exposure to magnetic resonance imaging (MRI) during the first trimester of pregnancy compared with nonexposure was not associated with increased risk of harm to the fetus or in early childhood, although gadolinium MRI at any time during pregnancy was associated with an increased risk of a broad set of rheumatological, inflammatory, or skin conditions and, possibly, for stillbirth or neonatal death, according to a study appearing in the Sept.
The benefits of exercise during pregnancy
Women who exercise during pregnancy are more likely to deliver vaginally than those who do not, and show no greater risk of preterm birth.

Related Pregnancy Reading:

Real Food for Pregnancy: The Science and Wisdom of Optimal Prenatal Nutrition
by Lily Nichols (Author)

The Mama Natural Week-by-Week Guide to Pregnancy and Childbirth
by Genevieve Howland (Author)

What to Expect When You're Expecting
by Heidi Murkoff (Author), Sharon Mazel (Contributor)

The Big Fat Activity Book for Pregnant People
by Jordan Reid (Author), Erin Williams (Author)

Dude, You're Gonna Be a Dad!: How to Get (Both of You) Through the Next 9 Months
by John Pfeiffer (Author)

Mayo Clinic Guide to a Healthy Pregnancy: 2nd Edition: Fully Revised and Updated
by Dr. Myra J. Wick M.D. Ph.D. (Author)

Expecting You: A Keepsake Pregnancy Journal
by Amelia Riedler (Author)

Mayo Clinic Guide to a Healthy Pregnancy: From Doctors Who Are Parents, Too!
by the pregnancy experts at Mayo Clinic (Author)

Bump to Birthday, Pregnancy & First Year Baby Journal : an award-winning journal / diary to help you hold onto memories of the growing bump, the birth & the first year with your baby
by Journals of a Lifetime (Author), Helen Stephens (Author), from you to me (Editor)

The Whole 9 Months: A Week-By-Week Pregnancy Nutrition Guide with Recipes for a Healthy Start
by Jennifer Lang MD (Author), Dana Angelo White MS RD (Author), Jessica Alba (Foreword)

Best Science Podcasts 2018

We have hand picked the best science podcasts for 2018. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Circular
We're told if the economy is growing, and if we keep producing, that's a good thing. But at what cost? This hour, TED speakers explore circular systems that regenerate and re-use what we already have. Guests include economist Kate Raworth, environmental activist Tristram Stuart, landscape architect Kate Orff, entrepreneur David Katz, and graphic designer Jessi Arrington.
Now Playing: Science for the People

#504 The Art of Logic
How can mathematics help us have better arguments? This week we spend the hour with "The Art of Logic in an Illogical World" author, mathematician Eugenia Cheng, as she makes her case that the logic of mathematics can combine with emotional resonance to allow us to have better debates and arguments. Along the way we learn a lot about rigorous logic using arguments you're probably having every day, while also learning a lot about our own underlying beliefs and assumptions.