Obstetrics and Gynecology Commons^™

The Rejoice Trial: A Phase 3 Randomized, Controlled Trial Evaluating The Safety And Efficacy Of A Novel Vaginal Estradiol Soft-Gel Capsule For Symptomatic Vulvar And Vaginal Atrophy., Ginger D Constantine, James A Simon, James H Pickar, David F Archer, Harvey Kushner, Brian Bernick, Gina Gasper, Shelli Graham, Sebastian Mirkin

Obstetrics and Gynecology Faculty Publications

OBJECTIVE: To evaluate the safety and efficacy of TX-004HR vaginal estradiol soft-gel capsules for moderate-to-severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy.

METHODS: In this randomized, double-blind, placebo-controlled, phase 3 study, postmenopausal women with a self-identified most bothersome symptom of dyspareunia received 4, 10, or 25 μg TX-004HR or placebo for 12 weeks. Four co-primary efficacy endpoints were change from baseline to week 12 in percentages of superficial and parabasal cells, vaginal pH, and severity of dyspareunia. Secondary endpoints included severity of vaginal dryness and vulvar and/or vaginal itching or irritation. Endometrial histology and adverse events (AEs) were included …

Effect Of Early Tranexamic Acid Administration On Mortality, Hysterectomy, And Other Morbidities In Women With Post-Partum Haemorrhage (Woman): An International, Randomised, Double-Blind, Placebo-Controlled Trial, Haleema Shakur-Still, Ian Roberts, Rizwana Chaudhri, Bukola Fawole, Mohamed El-Sheikh, Adesina L. Akintan, Zahida Qureshi, Hussein Kidanto, Bellington Vwalika, Abdulfetah Abdulkadir

Faculty of Health Sciences, East Africa

Background Post-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage.

Methods In this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition …

The Disappearance Of Nyoman And Ketut, Laura Michelle Garvie

Independent Study Project (ISP) Collection

No abstract provided.

Ovarian Cancer Incidence Corrected For Oophorectomy, Lauren A. Baldwin, Quan Chen, Thomas C. Tucker, Connie G. White, Robert N. Ore, Bin Huang

Obstetrics and Gynecology Faculty Publications

Current reported incidence rates for ovarian cancer may significantly underestimate the true rate because of the inclusion of women in the calculations who are not at risk for ovarian cancer due to prior benign salpingo-oophorectomy (SO). We have considered prior SO to more realistically estimate risk for ovarian cancer. Kentucky Health Claims Data, International Classification of Disease 9 (ICD-9) codes, Current Procedure Terminology (CPT) codes, and Kentucky Behavioral Risk Factor Surveillance System (BRFSS) Data were used to identify women who have undergone SO in Kentucky, and these women were removed from the at-risk pool in order to re-assess incidence rates …

Comparison Of Foeto-Maternal Outcome In Pregnant Women With Hepatitis E - A Review Of 12 Years., Tahira Naru, Farheen Yousuf, Ayesha Malik, Sumaira Naz, Humera Ismail

Department of Obstetrics & Gynaecology

Objective: To compare adverse maternal and foetal outcome in pregnant women with hepatitis E immunoglobulin M reactive versus non-reactive.
Methods: This retrospective study was conducted at the Aga Khan University Hospital, Karachi, and comprised records of pregnant patients at any gestational age with clinical and biochemical evidence of hepatitis E from January 2002 and December 2014. . Maternal and perinatal outcome of the subjects were analysed. SPSS 20 was used for data analysis.
Results: Out of the 200 subjects, 168(84 %) were hepatitis E immunoglobulin M reactive and 32(16%) were non-reactive. The overall mean age was 26.7±4.5 years. Also, 12(7%) …

A Prospective Study Of Maternal, Fetal And Neonatal Outcomes In The Setting Of Cesarean Section In Low- And Middle-Income Countries., Margo S. Harrison, Omrana Pasha, Sarah Saleem, Sumera Ali, Elwyn Chomba, Waldemar A. Carlo, Ana L. Garces, Nancy F. Krebs, K. Michael Hambidge, Shivaprasad S. Goudar, Bhala Kodkany, Sangappa Dhaded, Richard J. Derman, Archana Patel, Patricia L. Hibberd, Fabian Esamai, Edward A. Liechty, Janet L. Moore, Dennis Wallace, Elizabeth M. Mcclure, Menachem Miodovnik, Marion Koso-Thomas, Jose Belizan, Antoinette K. Tshefu, Melissa Bauserman, Robert L. Goldenberg

Global Health Articles

INTRODUCTION: Cesarean section (CS) rates are increasing globally with an unclear effect on pregnancy outcomes. The study objective was to quantify maternal and perinatal morbidity and mortality associated with CS compared with vaginal delivery (VD) both within and across sites in low- and middle-income countries.

MATERIAL AND METHODS: A prospective population-based study including home and facility births in 337 153 women with a VD and 47 308 women with a CS from 2010 to 2015 was performed in Guatemala, India, Kenya, Pakistan, Zambia and Democratic Republic of Congo. Women were enrolled during pregnancy; delivery and 6-week follow-up data were collected. …

Identificando Los Limites Del Acceso A La Salud Reproductiva: Un Análisis Sobre Las Experiencias Vividas Por Las Mujeres Guaraníes Con Los Servicios De La Salud Reproductiva En La Villa 31 De Buenos Aires, Amelia Mitchell

Independent Study Project (ISP) Collection

In order to serve the ‘public’, public health services must be accessible to everyone, without discrimination based on race, gender, social class, or geographic location, among other facets of identity. Reproductive health services, in particular, are a key service that must be adequately supplied in order to guarantee the health and wellbeing of a population. Reproductive healthcare not only allows individuals to decide if and when they wish to have a child, it also contributes to cancer prevention and the detrimental effects of sexually transmitted diseases. This investigation examines the experiences of Guaraní women that live within “Villa 31” of …

Clinical Significance Of A False Positive Glucose Challenge Test In Patients With A High Body Mass Index, A Borja, M Moretti, Nisha Lakhi

NYMC Faculty Publications

OBJECTIVE: To determine if there is an increased maternal or neonatal morbidity in overweight and obese patients with a false positive glucose challenge test (GCT). METHODS: Patients with a body mass index (BMI) >/=25.0 at registration were included in this prospective 36-month study. The study cohort consisted of patients with a false positive (FP) GCT, with two comparison cohorts: those with a (1) screen negative (SN) GCT result and (2) true positive (TP) GCT result. Risks were reported as odd ratios with 95% confidence intervals, with a P/=4000 g in the FP cohort, but this fell short of reaching statistical …

High-Grade Cervical Dysplasia In Pregnancy – Psychological And Medical Challenges, Denisa O. Balalau, Romina M. Sima, Nicolae Bacalbasa, Petrisor Banu, Cristian Bălălău, Liana Ples, Anca D. Stanescu

Journal of Mind and Medical Sciences

Despite being rare, the incidence of pregnancy-related cancer is expected to rise as women continue to delay childbearing and give birth later in their reproductive years. In this broad category, tumors like breast cancer, dermatological neoplasia and cervical cancer are most common and tend to arise in women of childbearing age. All pregnant women with clinical and cytologic suspicion of cervical cancer, except for squamous atypia or low-grade squamous intraepithelial lesions, should undergo colposcopy, with or without biopsy, the latter being avoided if possible due to possible complications which, although rare, may involve preterm labor initiation.

Some studies have attempted …

Unique Synergistic Formulation Of Curcumin, Epicatechin Gallate And Resveratrol, Tricurin, Suppresses Hpv E6, Eliminates Hpv+ Cancer Cells, And Inhibits Tumor Progression, Sumit Mukherjee, Priya Ranjan Debata, Rahman Hussaini, Kaushiki Chatterjee, Juliet N. E. Baidoo, Samay Sampat, Anita Szerszen, Joseph P. Navarra, Jimmie Fata, Elena Severinova, Probal Banerjee, Mario R. Castellanos

Publications and Research

Curcumin (from curry) (C) is highly potent against cervical cancer cells (CCC), but poor bioavailability has limited its clinical use. Similar natural polyphenols resveratrol (from grapes) (R), and epicatechin gallate (from green tea) (E) also display activity against CCC. By treating CCC (HeLa) with C, E, or R, or combinations of these compounds, we computed combination indices and observed a strong synergism among C, E, and R at the unique molar ratio 4:1:12.5. This combination, named as TriCurin, rapidly down regulated HPV18 E6 and NF-kB expression while concomitantly inducing the tumor suppressor protein p53 in HeLa cells. In the mouse …

Maternal Characteristics And Obstetrical Complications Impact Neonatal Outcomes In Indonesia: A Prospective Study., Trisari Anggondowati, Ayman A E El-Mohandes, S Nurul Qomariyah, Michele Kiely, Judith J Ryon, Reginald F Gipson, Benjamin Zinner, Anhari Achadi, Linda L Wright

Medicine Faculty Publications

BACKGROUND: We investigated associations between maternal characteristics, access to care, and obstetrical complications including near miss status on admission or during hospitalization on perinatal outcomes among Indonesian singletons.

METHODS: We prospectively collected data on inborn singletons at two hospitals in East Java. Data included socio-demographics, reproductive, obstetric and neonatal variables. Reduced multivariable models were constructed. Outcomes of interest included low and very low birthweight (LBW/VLBW), asphyxia and death.

RESULTS: Referral from a care facility was associated with a reduced risk of LBW and VLBW [AOR = 0.28, 95% CI = 0.11-0.69, AOR = 0.18, 95% CI = 0.04-0.75, respectively], stillbirth …

Symptoms Relevant To Surveillance For Ovarian Cancer, Robert M. Ore, Lauren Baldwin, Dylan Woolum, Erika Elliott, Christiaan Wijers, Chieh-Yu Chen, Rachel W. Miller, Christopher P. Desimone, Frederick R. Ueland, Richard J. Kryscio, John R. Van Nagell, Edward J. Pavlik

Obstetrics and Gynecology Faculty Publications

To examine how frequently and confidently healthy women report symptoms during surveillance for ovarian cancer. A symptoms questionnaire was administered to 24,526 women over multiple visits accounting for 70,734 reports. A query of reported confidence was included as a confidence score (CS). Chi square, McNemars test, ANOVA and multivariate analyses were performed. 17,623 women completed the symptoms questionnaire more than one time and > 9500 women completed it more than one four times for > 43,000 serially completed questionnaires. Reporting ovarian cancer symptoms was ~245 higher than ovarian cancer incidence. The positive predictive value (0.073%) for identifying ovarian cancer based on symptoms …

Galactose And Its Metabolites Deteriorate Metaphase Ii Mouse Oocyte Quality And Subsequent Embryo Development By Disrupting The Spindle Structure, Mili Thakur, Faten Shaeib, Sana N. Khan, Hamid-Reza Kohan-Ghader, Roohi Jeelani, Sarah R. Aldhaheri, Bernard Gonik, Husam M. Abu-Soud

C.S. Mott Center Research Publications

Premature ovarian insufficiency (POI) is a frequent long-term complication of classic galactosemia. The majority of women with this disorder develop POI, however rare spontaneous pregnancies have been reported. Here, we evaluate the effect of D-galactose and its metabolites, galactitol and galactose 1-phosphate, on oocyte quality as well as embryo development to elucidate the mechanism through which these compounds mediate oocyte deterioration. Metaphase II mouse oocytes (n=240), with and without cumulus cells (CCs), were exposed for 4hours to D-galactose (2μM), galactitol (11μM) and galactose 1-phosphate (0.1mM), (corresponding to plasma concentrations in patients on galactoserestricted diet) and compared to controls. The treated …

A Perspective On Ovarian Cancer Biomarkers: Past, Present And Yet-To-Come, Frederick R. Ueland

Obstetrics and Gynecology Faculty Publications

The history of biomarkers and ultrasonography dates back over more than 50 years. The present status of biomarkers used in the context of ovarian cancer is addressed. Attention is given to new interpretations of the etiology of ovarian cancer. Cancer antigen 125 (CA125) and multivariate index assays (Ova1, Risk of Ovarian Malignancy Algorithm, Overa) are biomarker-driven considerations that are presented. Integration of biomarkers into ovarian cancer diagnostics and screening are presented in conjunction with ultrasound. Consideration is given to the serial application of both biomarkers and ultrasound, as well as morphology-based indices. Attempts are made to foresee how individualized molecular …

Complications From Surgeries Related To Ovarian Cancer Screening, Lauren A. Baldwin, Edward J. Pavlik, Emma Ueland, Hannah E. Brown, Kelsey M. Ladd, Bin Huang, Christopher P. Desimone, John R. Van Nagell, Frederick R. Ueland, Rachel W. Miller

Obstetrics and Gynecology Faculty Publications

The aim of this study was to evaluate complications of surgical intervention for participants in the Kentucky Ovarian Cancer Screening Program and compare results to those of the Prostate, Lung, Colorectal and Ovarian Cancer Screening trial. A retrospective database review included 657 patients who underwent surgery for a positive screen in the Kentucky Ovarian Cancer Screening Program from 1988–2014. Data were abstracted from operative reports, discharge summaries, and office notes for 406 patients. Another 142 patients with incomplete records were interviewed by phone. Complete information was available for 548 patients. Complications were graded using the Clavien–Dindo (C–D) Classification of Surgical …

Reply To M. Lambertini Et Al, Kutluk Oktay, V Turan, G Bedoschi

NYMC Faculty Publications

No abstract provided.

Twin Chorionicity And Prospective Stillbirth Risk: Experience At A Tertiary Care Hospital, Shazia Masheer, Zaheena Islam, Dhanwanti Dileep, Shama Munim

Department of Obstetrics & Gynaecology

Objective: To determine the prospective risk of stillbirth, perinatal death and neonatal morbidities in twins.

Methods: This retrospective cohort study was conducted at the Aga Khan University Hospital, Karachi, and comprised cases of twin pregnancies from January 2001 to December 2012. . Cases of both monochorionic diamniotic and dichorionic diamniotic twin pregnancies were included. SPSS 19 was used for data analysis.

Results: Of the 394 cases, 84(21.3%) were monochorionic diamniotic twins and 310(78.7%) were dichorionic diamniotic twins. There were no cases of stillbirth beyond 30 and 34 weeks in monochorionic and dichorionic twins, respectively. Neonatal mortality stood reduced beyond 36 …

Reply To The Letter To The Editor, Anthony M. Vintzileos Md, John C. Smulian Md, Mph

Department of Obstetrics & Gynecology

No abstract provided.

A Comparison Of Colorimetric Assessment Of Vaginal Ph With Nugent Score For The Detection Of Bacterial Vaginosis., Matthew K. Hoffman, Mrutyunjaya B. Bellad, Umesh S. Charantimath, Avinash Kavi, Jyoti M. Nagmoti, Mahantesh B. Nagmoti, Ashalata A. Mallapur, Geetanjali M. Katageri, Umesh Y. Ramadurg, Sheshidhar G. Bannale, Amit P. Revankar, M. S. Ganachari, Richard J. Derman, Shivaprasad S. Goudar

Department of Obstetrics and Gynecology Faculty Papers

Background. A Nugent score > 7 has been defined as the gold standard for the diagnosis for bacterial vaginosis (BV), though it is resource intensive and impractical as point of care testing. We sought to determine if colorimetric assessment of vaginal pH can accurately predict the occurrence of BV. Methods. We performed a planned subanalysis of 1,216 pregnant women between 13 0/7 and 19 6/7 weeks who underwent vaginal examination as part of a randomized controlled trial. Using a standardized technique, specimens were obtained for colorimetric assessment and two separate slides for Gram staining. These slides were subsequently evaluated by two …

Double Balloon Cervical Ripening Catheter For Control Of Massive Hemorrhage In A Cervical Ectopic Pregnancy, N Zambrano, J Reilly, M Moretti, Nisha Lakhi

NYMC Faculty Publications

Cervical pregnancy can be complicated by perfuse vaginal bleeding. Mechanical compression directed at tamponing the cervical vessels can control hemostasis. There are several types of balloon catheters that have been described for cervical compression. However use of a double balloon catheter is a novel approach for cervical tamponade, as one balloon is positioned below the external cervical os and the second balloon is situated above in the internal cervical os. This compresses the cervix from internal os to external os between the two balloons, forming a "cervical sandwich." We describe this method of cervical tamponade using a silicone double balloon …

Infection Control In Labor And Delivery Room, Learning From The Small Hospital Based Project, Savera Aziz Ali, Sumera Aziz Ali

School of Nursing & Midwifery

Background: It has been estimated that around 36% of the neonatal deaths occur due to infection in the lower and middle income countries. Infection control is a more substantial area of concern, particularly in Labor and delivery room. Multiple factors can cause infection in the labor room, therefore it is important to assess various factors of maternal and neonatal infection. Hence we explored multiple factors through this project and developed the action plan to address those factors effectively.
Methods: During our Leadership and Management course, we conducted a project in Labor room pertaining to a prevalent issue. The whole process …

Placental Genetic Variations In Vitamin D Metabolism And Birthweight., Tsegaselassie Workalemahu, Sylvia E Badon, Michal Dishi-Galitzky, Chunfang Qiu, Michelle A Williams, Tanya Sorensen, Daniel A Enquobahrie

Articles, Abstracts, and Reports

INTRODUCTION: Vitamin D has pleiotropic functions that regulate fetal growth and development. We investigated associations of common placental genetic variations in vitamin D metabolism with birthweight.

METHODS: The study was conducted among participants (506 maternal-infant pairs) of a pregnancy cohort study. Data were collected using interviewer-administered questionnaires and post-delivery medical record abstraction. DNA, extracted from placental samples collected at delivery, was genotyped for eight single nucleotide polymorphisms (SNPs) in five vitamin D metabolism genes (CUBN, LRP2, VDR, GC, and CYP2R1). Linear and logistic regression models were used to evaluate associations of SNPs with birthweight and risk of low birthweight, respectively. …

Surrogate Pregnancy After Prenatal Diagnosis Of Spina Bifida., Lynnette J. Mazur, Mary Kay Kisthardt, Helen H. Kim, Laura M. Rosas, John Lantos

Manuscripts, Articles, Book Chapters and Other Papers

Some pregnancies today involve infertile individuals or couples who contract with a fertile woman to carry a pregnancy for them. The woman who carries the pregnancy is referred to as a "gestational carrier." The use of such arrangements is increasing. Most of the time, these arrangements play out as planned; sometimes, however, problems arise. This article discusses a case in which a fetal diagnosis of spina bifida led the infertile couple to request that the gestational carrier terminate the pregnancy, and the gestational carrier did not wish to do so. Experts in the medical and legal issues surrounding surrogacy discuss …

Reply., Anthony M. Vintzileos Md, John C. Smulian Md, Mph

Department of Obstetrics & Gynecology

No abstract provided.

Group Medical Visits To Provide Gynecologic Care For Women Affected By Breast Cancer, Sally R. Greenwald, Sarah Watson, Mindy Goldman, Tami S. Rowen

Journal of Patient-Centered Research and Reviews

Purpose

Women with breast cancer have complex and unique gynecologic needs that are challenging to effectively and comprehensively meet in a traditional gynecology visit format. Group medical visits are an effective and well-received model of care in other disease settings and can provide comprehensive health education as an adjunct to one-on-one evaluation and treatment. There are limited data regarding the use of this type of health care delivery in providing gynecology-focused care to women affected by breast cancer.

Methods

A group medical visit model was created for gynecology providers to see new breast cancer patient consults. From May 2012 to …

Self-Reported Tobacco Use And Correlation With Umbilical Cord Blood Cotinine Levels At Delivery Among Appalachian Gravidas, Jesse Cottrell, Brenda L. Mitchell, Pooja N. Sangani, D'Andrea S. Thomas, Monica A. Valentovic

Marshall Journal of Medicine

The detrimental effects of cigarette use during pregnancy are well documented. Studies have shown that cigarette smoking while pregnant is associated with multiple adverse outcomes including: pre-term birth, placental abruption, placenta previa, fetal growth restriction, stillbirth, increased rate of birth defects, and increased risk of sudden infant death syndrome. Cotinine is the primary metabolite of nicotine and allows for measurement of active as well as passive exposure. Cotinine freely cross the placental barrier and maternal concentrations are closely correlated with newborn plasma levels. The aim of this study was to compare maternally reported rates of tobacco use to fetal umbilical …

Effect Of Puerperal Infections On Early Neonatal Mortality: A Secondary Analysis Of Six Demographic And Health Surveys, Saverio Bellizzi, Quique Bassat, Howard L. Sobel, Mohamed M. Ali, Marleen Temmerman

Obstetrics and Gynaecology, East Africa

Background: Around 1.5 million annual neonatal deaths occur in the first week of life, and infections represent one of the major causes in developing countries. Neonatal sepsis is often strictly connected to infection of the maternal genital tract during labour.

Methods: The association between signs suggestive of puerperal infection and early neonatal mortality (life) was performed using Demographic and Health Surveys (DHS) data of six countries, conducted between 2010 and 2013. The population attributable fraction (PAF) was generated using the estimates on early neonatal mortality of a 1990-2013 systematic analysis for the Global Burden of Disease Study.

Results: Signs of …

Caesarean Sections And For-Profit Status Of Hospitals: Systematic Review And Meta-Analysis, Ilir Hoxha, Lamprini Syrogiannouli, Xhyljeta Luta, Kali Tal, David C. Goodman

Dartmouth Scholarship

Objective: Financial incentives may encourage private for-profit providers to perform more caesarean section (CS) than non-profit hospitals. We therefore sought to determine the association of for-profit status of hospital and odds of CS.

Design: Systematic review and meta-analysis. Data sources: MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews from the first year of records through February 2016. Eligibility criteria: To be eligible, studies had to report data to allow the calculation of ORs of CS comparing private for-profit hospitals with public or private non-profit hospitals in a specific geographic area. Outcomes: The prespecified primary outcome was the adjusted OR …

Maternal And Newborn Health In Karnataka State, India: The Community Level Interventions For Pre-Eclampsia (Clip) Trial's Baseline Study Results., Mrutynjaya B. Bellad, Marianne Vidler, Narayan V. Honnungar, Ashalata Mallapur, Umesh Ramadurg, Umesh Charanthimath, Geetanjali Katageri, Shashidhar Bannale, Avinash Kavi, Chandrashekhar Karadiguddi, Sumedha Sharma, Tang Lee, Jing Li, Beth Payne, Laura Magee, Peter Von Dadelszen, Richard Derman, Shivaprasad S. Goudar

Department of Obstetrics and Gynecology Faculty Papers

Existing vital health statistics registries in India have been unable to provide reliable estimates of maternal and newborn mortality and morbidity, and region-specific health estimates are essential to the planning and monitoring of health interventions. This study was designed to assess baseline rates as the precursor to a community-based cluster randomized control trial (cRCT)-Community Level Interventions for Pre-eclampsia (CLIP) Trial (NCT01911494; CTRI/2014/01/004352). The objective was to describe baseline demographics and health outcomes prior to initiation of the CLIP trial and to improve knowledge of population-level health, in particular of maternal and neonatal outcomes related to hypertensive disorders of pregnancy, in …

The Effects Of Asking A Fertility Intention Question In Primary Care Settings: A Systematic Review Protocol, Paul A. Henning, Carolyne K. Burgess, Heidi E. Jones, Wendy V. Norman

Publications and Research

Background: Planning for pregnancy has been associated with reduced unwanted pregnancies and improved pregnancy outcomes. Despite the benefits of planned pregnancy, there are no guideline recommendations on routine counseling regarding pregnancy intention in primary care settings. The objective of the systematic review is to determine the effectiveness of incorporating questions of pregnancy intention into primary care.

Methods: A systematic search of the literature will be conducted for any studies comparing questions of pregnancy intention in primary care settings with no intervention or a control intervention. Types of studies will include randomized controlled trials, non-randomized trials, and observation studies. Participants …