Most Strokes In Women With Preeclampsia During Pregnancy Occur After Delivery

MedicalResearch.com Interview with:

Eliza Miller, M.D. Vascular neurology fellow New York-Presbyterian Hospital/Columbia University Medical Center New York City

Dr. Eliza Miller

Eliza Miller, M.D.
Vascular neurology fellow
New York-Presbyterian Hospital/Columbia University Medical Center
New York City 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Preeclampsia is a common disorder that causes high blood pressure during pregnancy. It affects about 1 in 20 pregnant women. Women with preeclampsia are at higher risk for stroke during pregnancy and post-partum, but it’s very difficult to predict who is going to have a stroke. Our study looked at a large dataset of billing data from New York State, and compared women who had preeclampsia and strokes to women who had preeclampsia but did not have a stroke.

We found that preeclamptic women with urinary tract infections, bleeding or clotting disorders, or preexisting high blood pressure were at higher risk of having strokes during pregnancy or postpartum.

Continue reading

Risk of Postoperative Venous Thromboembolism among Pregnant Women

MedicalResearch.com Interview with:

Hirohito Ichii, M.D, Ph.D, FACS Associate Professor of Clinical Surgery Division of Transplantation, Department of Surgery University of California, Irvine, Orange CA 92868

Dr. Hirohito Ichii

Hirohito Ichii, M.D, Ph.D, FACS
Associate Professor of Clinical Surgery
Division of Transplantation,
Department of Surgery
University of California, Irvine,
Orange CA 92868

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Venous thromboembolism (VTE) is a critical complication after surgery. Although pregnancy is known to increase the risk of VTE 4- to 5-fold, there are scarce data on the risk of VTE among pregnant women who are undergoing surgery. In this study using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) data, we observed that pregnant women, compared to matched non-pregnant women, experienced 93% higher likelihood of developing VTE. Absolute incidence of VTE among pregnant vs. matched non-pregnant were 0.5% vs. 0.3%.

Continue reading

Phase 3 Studies Demonstrate Reduce Endometriosis-Associated Pain with Elagolix

MedicalResearch.com Interview with:

Hugh S. Taylor, M.D. Anitta O’keeffe Young Professor and Chair Departemnt of Obstetrics, Gynecology and Reproductive Sciences Yale School of Medicine Chief of Obstetrics and Gynecology Yale-New Haven Hospital

Dr. Taylor

Hugh S. Taylor, M.D.
Anitta O’keeffe Young Professor and Chair
Departemnt of Obstetrics, Gynecology and Reproductive Sciences
Yale School of Medicine
Chief of Obstetrics and Gynecology
Yale-New Haven Hospital

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Elagolix is an investigational, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy.

Data from two replicate Phase 3 studies evaluating the efficacy and safety of elagolix were published in the New England Journal of Medicine. Elagolix demonstrated dose-dependent superiority in reducing daily menstrual and non-menstrual pelvic pain associated with endometriosis compared to placebo. At month three and month six, patients treated with elagolix reported statistically significant reductions in scores for menstrual pain (dysmenorrhea, DYS) and non-menstrual pelvic pain (NMPP) associated with endometriosis as measured by the Daily Assessment of Endometriosis Pain scale. The safety profile of elagolix was consistent across both Phase 3 trials and also consistent with prior elagolix studies.

Ultimately, the studies showed that both elagolix doses (150 mg QD and 200 mg BID) were effective in improving dysmenorrhea, non-menstrual pelvic pain and quality of life over 6 months in women with endometriosis-associated pain. The elagolix safety/tolerability profile was consistent with the mechanism of action.

Continue reading

Can Telemedicine Enable Women To Safely Manage Their Own Abortions?

MedicalResearch.com Interview with:
Abigail R.A. Aiken, MD, MPH, PhD Assistant Professor LBJ School of Public Affairs Faculty Associate Population Research Center University of Texas at Austin Austin, TX, 78713Abigail R.A. Aiken, MD, MPH, PhD

Assistant Professor
LBJ School of Public Affairs
Faculty Associate
Population Research Center
University of Texas at Austin
Austin, TX, 78713

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We’ve known for some time that women in Ireland and Northern Ireland self-source their own abortions using online telemedicine. In fact, this model has revolutionized abortion access for Irish women. Yet very little was previously known about the outcomes of those abortions. How safe and effective are they? We wanted to address that knowledge gap with this study.

What this research shows is that self-sourced medication abortion, conducted entirely outside the formal healthcare setting, can have high rates of effectiveness and low rates of adverse outcomes. Women can successfully manage their own abortions and recognize the symptoms of potential complications. Among the small number who experienced such a symptom, virtually all sought in-person medical attention as advised.

Continue reading

No Increased Risk of Congenital Abnormalities Found With Paternal Use of Immunosuppressant Therapies

MedicalResearch.com Interview with:

Alexander Egeberg, MD PhD National Allergy Research Centre, Departments of Dermato-Allergology and Cardiology Herlev and Gentofte University Hospital, University of Copenhagen Hellerup, Denmark

Dr. Alexander Egeberg

Alexander Egeberg, MD PhD
Gentofte Hospital
Department of Dermatology and Allergy
Denmark

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: An issue that frequently arise in clinical practice is the question from patients whether they should discontinue their therapy if they want to have children. Since immunosuppressant agents are frequently used for a number of conditions, and discontinuation could lead to disease flaring, assessment of the potential impact of such drugs on birth outcomes is important.

In our study, we examined birth outcomes in children whose father had received treatment with methotrexate, azathioprine, cyclosporine, and mycophenolate mofetil in the time leading up to conception.

Importantly, we found no increased risk of congenital abnormalities, low birth weight, or preterm birth associated with paternal treatment with these drugs.

Continue reading

Pregnant Women Exposed To Cold Temperatures May Have Lower Risk of Gestational Diabetes

MedicalResearch.com Interview with:

Dr. Gillian Booth PhD Researcher at St. Michael's and the Institute for Clinical Evaluative Sciences (ICES)

Dr.Gillian Booth

Dr. Gillian Booth PhD
Researcher at St. Michael’s and the
Institute for Clinical Evaluative Sciences (ICES)

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The impact of climate change on health is becoming increasingly relevant given the rise in global air temperature, and there is growing evidence supporting a link between air temperature, metabolic function, and energy expenditure. We know from animal models and small studies in humans that cold exposure and activate a type of fat known as brown fat and it appears that this process can improve sensitivity to insulin. However no studies have yet looked at air temperature and the development of diabetes. So we decided to examine the relationship between outdoor air temperature and gestational diabetes – a temporary form of diabetes that arises in the second trimester of pregnancy.

Continue reading

Fetal Reduction in Multifetal Pregnancies Results in Fewer Preterm Births and Deaths

MedicalResearch.com Interview with:

Neda Razaz, PhD, MPH Postdoctoral Fellow Reproductive Epidemiology Unit Karolinska Institutet

Dr. Razaz

Neda Razaz, PhD, MPH
Postdoctoral Fellow
Reproductive Epidemiology Unit
Karolinska Institutet

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Multiple births of twins and triplets – and the associated health risks – have increased in many high-income countries, with a respective two-fold and three-fold increase in recent decades.

In Canada, triplet births or higher have increased from 52.2 per 100 000 live births to 83.5 between 1991 and 2009, mainly because of an increase in fertility treatments for older women of child-bearing age. In this study we found that among twin and triplet pregnancies that were reduced to singleton or twin pregnancies, there was a substantial reduction in complications such as preterm birth and very preterm birth. Although rates of death and serious illness were not lower among all multifetal pregnancies that were reduced, pregnancies that resulted from fertility treatments did show a significant reduction in rates of death or serious illness following fetal reduction.

Continue reading

Cervical Cancer Is Not Just a Young Woman’s Disease: Older Women Should Have PAP Smears Too

MedicalResearch.com Interview with:

Mary C. White, ScD Epidemiology and Applied Research Branch Division of Cancer Prevention and Control, CDC Atlanta GA 30341

Dr. Mary White

Mary C. White, ScD
Epidemiology and Applied Research Branch
Division of Cancer Prevention and Control, CDC
Atlanta GA 30341

MedicalResearch.com: What is the background for this study?

Response: For women between the ages of 21 to 65, Pap testing every three years, or Pap testing with HPV co-testing every five years, can prevent cervical cancers and deaths.

Current recommendations state that women 65 and older and not otherwise at special risk can skip Pap tests, but only if they have had three consecutive negative Pap screening tests or two consecutive negative co-tests over the past 10 years, with the most recent done within the past five years.

We used data from two federal cancer registry programs to examine how cervical cancer risk changes with age, after excluding women who have had a hysterectomy. We also examined data from a federal national health survey to examine the proportion of women who either had never been tested or had not been tested in the last 5 years.

Continue reading

Some Antibiotics Linked To Increased Risk of Miscarriage

MedicalResearch.com Interview with:

Anick Bérard PhD FISPE Research chair FRQ-S on Medications and Pregnancy and Director, Réseau Québécois de recherche sur le médicament (RQRM) and Professor, Research Chair on Medications, Pregnancy and Lactation Faculty of Pharmacy University of Montreal and Director, Research Unit on Medications and Pregnancy Research Center CHU Ste-Justine

Dr. Anick Bérard

Anick Bérard PhD FISPE
Research chair FRQS on Medications and Pregnancy
Director, Réseau Québécois de recherche sur le médicament (RQRM)
Professor, Research Chair on Medications, Pregnancy and Lactation
Faculty of Pharmacy, University of Montreal
Director, Research Unit on Medications and Pregnancy
Research Center, CHU Ste-Justine

MedicalResearch.com: The Danish study you cite reported a connection between antibiotics and miscarriage – why was further research of this topic necessary?

Response: Given that a single study will assess an association, repetition of findings are essential in order to assess causality. For example, we were able to conclude that smoking was causing lung cancer after 10 years of observational research on the topic showing concordant associations.

In addition, antibiotic prescription patterns vary from country to country, hence the importance of studying the research question in various patient populations.

Finally, our cohort has validated exposure status, gestational age (first day of pregnancy) and miscarriage cases – our study was also able to look at types of antibiotics.

Continue reading

Does Cell Phone Use During Pregnancy Increase Childhood Behavioral Problems?

MedicalResearch.com Interview with:
Laura Birks, MPH, Predoctoral Fellow
ISGlobal
Instituto de Salud Global de Barcelona – Campus MAR
Barcelona Biomedical Research Park (PRBB) (office 183.01B)
Barcelona, Spain

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Previous studies in Denmark and the Netherlands have reported associations between prenatal cell phone use and child behavioral problems, but findings have been inconsistent and based on retrospective assessment of cell phone use. This study aimed to assess this association in a multi-national analysis, using data from three cohorts with prospective data on prenatal cell phone use, together with previously published data from two cohorts with retrospectively collected cell phone use data.

We found that cell phone use during pregnancy was associated with increased risk for behavioral problems in offspring, specifically hyperactivity/inattention problems. This association was fairly consistent across cohorts and between cohorts with retrospectively and prospectively collected cell phone use data. While our models were adjusted for many confounders, it is possible that other factors could explain this association, such as hyperactivity in the mother or parenting styles (variables that were not collected in these cohorts). Furthermore, to date there is no known biological mechanism that could explain the association.

Continue reading

Pregnant Women Should Have Blood Pressure Screening for Preeclampsia Throughout Pregnancy

MedicalResearch.com Interview with:

Dr. Maureen Phipps, USPTS Task Force member Department chair and Chace-Joukowsky professor of obstetrics and gynecology Assistant dean for teaching and research on women's health Warren Alpert Medical School of Brown University

Dr. Phipps

Dr. Maureen Phipps, USPTS Task Force member
Department chair and Chace-Joukowsky professor of obstetrics and gynecology
Assistant dean for teaching and research on women’s health
Warren Alpert Medical School of Brown University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Preeclampsia, which includes high blood pressure after 20 weeks of pregnancy, is one of the most serious health problems affecting pregnant women. After reviewing the evidence, the Task Force found the benefits of screening for preeclampsia outweighed the harms and recommended screening pregnant women for preeclampsia with blood pressure measurements throughout pregnancy. The evidence showed mothers and their babies are likely to benefit from screening, as screening leads to treatment that reduces their risk of severe complications, including death.

Continue reading

AbbVie Developing Elagolix For Heavy Menstrual Bleeding Associated With Fibroids

MedicalResearch.com Interview with:

Dr. James A. Simon, MD CCD, NCMP, FACOG</strong> Clinical professor of obstetrics and gynecology George Washington University, and Medical director, Women's Health & Research Consultants® Washington, D.C

Dr. Simon

Dr. James A. Simon, MD CCD, NCMP, FACOG
Clinical professor of obstetrics and gynecology
George Washington University, and
Medical director, Women’s Health & Research Consultants®
Washington, D.C

MedicalResearch.com: What is the background for this study?

Response: The Phase 2b uterine fibroids study was a 24-week, multicenter, double-blind, randomized, placebo-controlled, parallel group clinical trial that evaluated the efficacy and safety of elagolix alone or in combination with add-back therapy (estradiol/norethindrone acetate) in women with heavy uterine bleeding associated with uterine fibroids. Elagolix is currently being investigated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis.

The study was conducted in 567 premenopausal women, age 18 to 51, at 100 sites in the United States, Canada, Puerto Rico, Chile and the United Kingdom. The two cohort design study evaluated the safety and efficacy of two elagolix treatment regimens (300mg BID and 600mg QD) alone and in combination with two different strengths of add-back therapy (estradiol/norethindrone acetate). The data presented were results from the 300mg cohort. Results from the 600mg cohort were similar and will be reported in a future publication.

Current non-surgical treatments indicated for uterine fibroids are limited, and women suffering from heavy menstrual bleeding associated with uterine fibroids need more options.

Continue reading