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.

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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.

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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.

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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.

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Birth Outcomes Among Adolescent and Young Adult Cancer Survivors

MedicalResearch.com Interview with:

Hazel B. Nichols, PhD, UNC, assistant professor Lineberger Comprehensive Cancer Center member UNC Gillings School of Global Public Health.

Dr. Nichols

Hazel B. Nichols, PhD, UNC
Assistant professor
Lineberger Comprehensive Cancer Center member
UNC Gillings School of Global Public Health.

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

Response: Each year more than 45,000 adolescent and young adult women (AYA, ages 15-39 years) are diagnosed with cancer in the United States. While many of these women may wish to have children in the years following diagnosis, there is currently little information available to address their concerns about the impact of cancer diagnosis and treatment on future pregnancy.

We identified >2,500 women who had a child after their cancer diagnosis using data from the North Carolina Central Cancer registry and statewide birth certificate files. We investigated whether adverse birth outcomes, such as preterm birth and low birth weight, were more common among AYA cancer survivors compared to women without cancer. We also looked at infant Apgar scores, which measure newborn health, and a calculation called small-for-gestational age, which can indicate restricted growth during pregnancy.

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Human Placenta May Be Most Vulnerable To Zika In First Trimester

MedicalResearch.com Interview with:

R. Michael Roberts

Dr. R. Michael Roberts

R. Michael Roberts PhD
Curators’ Distinguished Professor
240b Bond Life Sciences Center
Columbia, Missouri 65211-7310

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

Response: My background in placental biology and in communication between the embryo and the mother in early pregnancy made me curious about how the zika virus (ZIKV) crossed the placenta in early pregnancy to cause microcephaly. My group had been working on a laboratory model for placental trophoblast for over 10 years. We generate trophoblast from human pluripotent cells (embryonic stem cells and induced pluripotent stem cells) by exposing them to the growth factor BMP4 and two pharmaceuticals that inhibit the signaling pathways necessary to maintain pluripotency. I was curious to determine whether or not ZIKV could infect these cells, replicate, and release infectious virus, because work from my collaborator Yoel Sadovsky at the University of Pittsburgh indicated that the mature placenta was likely to be resistant to infection.

MedicalResearch.com: What are the main findings?

Response: There are, I believe two striking outcomes from this work.

One is that the results indicate that the human placenta is likely most vulnerable to infection by Zika during the first trimester. We also suggest that women whose fetus is affected from an infection occurring later in pregnancy likely had a past dengue infection. The second striking result is that the African strain of Zika may have greater virulence towards early placenta than the Asian strains, such as the ones that have spread in the New World.

The work with the virus only began when we realized that term trophoblasts lacked expression of the genes that encode the protein factors that promote flavivirus infection (ZIKV is a flavivirus, like dengue, West Nile virus), e.g. TYRO3, AXL, MERTK, and also had a poised innate immune system that would counteract virus replication. Conversely, the trophoblasts we create from embryonic stem cells had the factors that would promote virus uptake, but seemed ill-prepared to counteract virus replication once infection occurred. In other words, the early placental trophoblasts were potentially more susceptible to infection. We confirmed this hypothesis with two strains of ZIKV (an Asian strain related to the one encountered in Brazil, and an African strain often considered to be relatively benign). What was unexpected was the African strain appeared to be more virulent than the Asian strain.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Whether the early placenta could be protected by some sort of immune therapy or by prior vaccination of the mother is clearly uncertain at present. Vaccination programs have not been altogether successful when used to protect against Dengue, which is a virus related to ZIKV.

There is evidence that the early placenta is also permissive to other viruses, such as Rubella. Also there is a very interesting paper in the Journal of the American medical Association by Honein et al. that was published on December 15, 2016. In this study, the overall risk for microcephaly and other brain abnormalities in infants born to a large cohort of U.S. women exposed to ZIKV while traveling (n = 442) was 5.9 % (18), and, of these, there were no cases noted among the women known to have been infected during their second or third trimesters. In Brazil, women appear to be at risk for fetal infections by ZIKV throughout their pregnancies but this may be because they had experienced an earlier infection by Dengue. I have discussed this puzzle in the paper.

I have no disclosures to make, nor conflicts of interest regarding the research or this response to your queries.

Citation:

PNAS Plus – Biological Sciences – Applied Biological Sciences:
Megan A. Sheridan, Dinar Yunusov, Velmurugan Balaraman, Andrei P. Alexenko, Shinichiro Yabe, Sergio Verjovski-Almeida, Danny J. Schust, Alexander W. Franz, Yoel Sadovsky, Toshihiko Ezashi, and R. Michael Roberts
Vulnerability of primitive human placental trophoblast to Zika virus PNAS 2017 114 (9) E1587-E1596; published ahead of print February 13, 2017, doi:10.1073/pnas.1616097114

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Maternal Cancer During Pregnancy Linked To Stillbirths and Infant Mortality

MedicalResearch.com Interview with:

Donghao Lu. PhD student Department of Medical Epidemiology and Biostatistics Karolinska Institute

Dr. Donghao Lu

Donghao Lu PhD student
Department of Medical Epidemiology and Biostatistics
Karolinska Institute

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

Response: Cancer during pregnancy is a rare event. Whether prenatal exposure to a maternal malignancy and its treatment during pregnancy impair fetal development and neonatal health is, however, of great clinical concern. The risks of fatal outcomes such as stillbirth and infant mortality, however, have rarely been successfully explored in pregnancies complicated with cancer, in either clinical or population-based studies.

MedicalResearch.com: What are the main findings?

Response: Maternal cancer diagnosed during pregnancy was associated with increased risk of stillbirth (Incidence Rate Ratio, IRR, 2.5; 95% CI, 1.2 to 5.0), mainly stillbirths assessed as small for gestational age (SGA), and with increased risk of preterm SGA births (relative risk 3.0; 95% CI, 2.1 to 4.4). Maternal cancer diagnosed during pregnancy or the year after pregnancy were associated with increased risks of both neonatal mortality (deaths within 0 to 27 days; IRR, 2.7; 95% CI, 1.3 to 5.6 and IRR, 2.0; 95% CI, 1.2 to 3.2, respectively) and preterm birth (IRR, 5.8; 95% CI, 5.3 to 6.5 and IRR, 1.6; 95% CI, 1.4 to 1.8, respectively). The positive association with preterm birth was due to iatrogenic instead of spontaneous preterm birth. Preterm birth explained 89% of the association of maternal cancer during pregnancy with neonatal mortality.

MedicalResearch.com: What should readers take away from your report?

Response: Maternal cancer diagnosed during pregnancy was associated with increased risks of stillbirths assessed as SGA and preterm SGA live birth, suggesting that cancer and its treatment during pregnancy may impair fetal growth. Maternal cancer diagnosed during or shortly after pregnancy was associated with an increased risk of neonatal mortality, largely attributable to iatrogenic preterm birth. Although stillbirth and neonatal death are rare outcomes, the absolute risks of SGA and preterm birth are not small in pregnancies complicated with cancer. Careful monitoring of fetal growth and cautious decision making on the choices as well as the timing of preterm delivery should therefore be reinforced in these pregnancies.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Sweden is among the high-income countries with the lowest stillbirth and infant mortality rates, and these rates have decreased over time in many populations. Future studies in other populations are warranted to confirm our findings. Our data have also highlighted several cancer types, such as blood cancer, ovarian cancer, and cervical cancer, which entail highly increased risk of SGA or preterm birth and might be worthy of further exploration. 

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Maternal Cancer During Pregnancy and Risks of Stillbirth and Infant Mortality

Donghao Lu, Jonas F. Ludvigsson, Karin E. Smedby, Katja Fall, Unnur Valdimarsdóttir, Sven Cnattingius, and Fang Fang

Journal of Clinical Oncology
DOI: 10.1200/JCO.2016.69.9439 Journal of Clinical Oncology – published online before print March 6, 2017

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Almost 40% of Assisted Reproductive Infants Are Multiple Births

MedicalResearch.com Interview with:
Saswati Sunderam, PhD

Division of Reproductive Health
National Center for Chronic Disease Prevention and Health Promotion
CDC.

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

Response: Assisted Reproductive Technology Surveillance – United States, 2014, the surveillance summary published this week in CDC’s Morbidity and Mortality Weekly Report (MMWR), presents state-specific data on assisted reproductive technology (ART) use and outcomes.

The report compares ART infant outcome data with outcomes for all infants born in the U.S. in 2014, and provides data on the contributions of  Assisted Reproductive Technology to total infants born, multiple birth infants, low birth weight infants, and preterm infants for each U.S. state, the District of Columbia, and Puerto Rico.

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Oxytocin During Labor Linked to Increased Risk of Postpartum Depression

MedicalResearch.com Interview with:

Kristina M. Deligiannidis, MD Associate Professor, Center for Psychiatric Neuroscience The Feinstein Institute for Medical Research Director, Women’s Behavioral Health, Zucker Hillside Hospital Northwell Health Associate Professor, Psychiatry and Obstetrics & Gynecology Hofstra Northwell School of Medicine

Dr. Kristina Deligiannidis

Kristina M. Deligiannidis, MD
Associate Professor
Center for Psychiatric Neuroscience
The Feinstein Institute for Medical Research
Director, Women’s Behavioral Health
Zucker Hillside Hospital Northwell Health
Associate Professor
Psychiatry and Obstetrics & Gynecology
Hofstra Northwell School of Medicine

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

Response: Because of effects on social behavior, including maternal behavior, oxytocin has often been seen as a potential mediator of postpartum depression and anxiety.

The original objective of our study was to examine the relationship between the use of synthetic oxytocin during and after labor and the development of depressive and anxiety disorders within the first year postpartum. We hypothesized that women exposed to synthetic oxytocin before or during labor would have a reduced risk of postpartum depressive and anxiety disorders compared with those without any exposure. Our findings told the opposite story.

We found that peripartum synthetic oxytocin exposure was associated with an increase in risk for the development of postpartum depression and anxiety.

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Maternal Mortality and Morbidity Increased on Weekends

MedicalResearch.com Interview with;
Dr. Amirhossein Moaddab
Postdoctoral Research Fellow at Baylor College of Medicine
Houston, Texas

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

Response: Based on data from the Centers for Disease Control and Prevention, the United States maternal mortality ratio is three to four times higher than that of most other developed nations. Previous studies from the demonstrated a possible association between weekend hospital admissions and higher rates of mortality and poor health outcomes.

We investigated differences in maternal and fetal death ratios on weekends compared to weekdays and during different months of the year. In addition we investigated the presence of any medical and obstetrics complications in women who gave birth to a live child and in their offspring by day of delivery.

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Effects of Delayed Vs Early Umbilical Cord Clamping on Infant Anemia

Ola Andersson, MD, PhD Department of Women’s and Children’s Health Uppsala University, Uppsala, Sweden

MedicalResearch.com Interview with:
Dr. Ola Andersson MD, PhD
Uppsala University,
Uppsala, Sweden

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

Response: Anemia affects over 40% of all children under 5 years of age in the world. Anemia can impinge mental and physical performance, and is associated with long-term deterioration in growth and development. Iron deficiency is the reason for anemia in approximately 50% of the children.is. When clamping of the umbilical cord is delayed, ie after 3 minutes, iron deficiency up to 6 months of age can be prevented, but it has not been shown to prevent iron deficiency or anemia in older infants.

At birth, approximately 1/3 of the child’s blood is in the placenta. If clamping of the umbilical cord is done immediately (early cord clamping), the blood will remain in the placenta and go to waste (or can be stored in stem cell banks). If instead clamping is postponed for 3 minutes, most of the blood can flow back to the child as an extra blood transfusion, consisting of about one deciliter (1/2 cup) of blood, equivalent to about 2 liters (half a US gallon) of an adult. A blood donor leaves 0.4-0.5 liters of blood.

Blood contains red blood cells that contain hemoglobin. Hemoglobin carries oxygen to the tissues of the body. Hemoglobin contains a lot of iron, and the extra deciliter of blood may contain iron that corresponds to 3-4 months of the need for an infant.

The World Health Organization (WHO) recommends umbilical cord clamping at 1 minute or later, American College of Obstetricians and Gynecologists (ACOG) recommends umbilical cord clamping at 30-60 seconds or later.

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Cesarean Section Rates Vary Across US Hospitals

MedicalResearch.com Interview with:
Kamila Mistry, PhD MPH
AHRQ

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

Response: Although the overall cesarean section (C-section) rate in the United States has declined slightly in recent years, nearly a third of all births continue to be delivered by C-section—higher than in many other industrialized countries. A number of medical as well as nonmedical factors may contribute to high C-section rates.

C-section is the most common surgical procedure performed in the United States. This operation carries additional risks compared with vaginal delivery, such as infection and postoperative pain. A C-section also may make it more difficult for the mother to establish breastfeeding and may complicate subsequent pregnancies.

Consensus guidelines from the American Congress of Obstetricians and Gynecologists and other national efforts to improve perinatal care have shown promise in reducing nonmedically indicated C-sections. However, recent research has found wide variation in hospital C-section rates even for low-risk deliveries.
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