• Home
  • Beverly Winikoff
Beverly Winikoff

Beverly Winikoff

About

361
Publications
77,200
Reads
How we measure 'reads'
A 'read' is counted each time someone views a publication summary (such as the title, abstract, and list of authors), clicks on a figure, or views or downloads the full-text. Learn more
10,206
Citations

Publications

Publications (361)
Preprint
Full-text available
Background Although induction of labour is becoming more common worldwide, there are few studies that assess women’s satisfaction with it. The newly developed Participant Generated Experience and Satisfaction (PaGES) Index collects brief qualitative data and quantifies it, allowing detailed satisfaction data to be collected on large populations. Th...
Article
Purpose: To evaluate the feasibility and acceptability of outpatient medical induction at 13-18 weeks' gestation to limit overnight hospital stays. Methods: In this prospective cohort study, participants with 13-18-week pregnancies seeking abortions at two government hospitals swallowed mifepristone 200 mg and self-administered misoprostol 400 m...
Article
Background Induction of labor (IOL) is an increasingly common intervention, but experiences and preferences of induction methods are under-researched particularly in low -and middle-income countries. Understanding these perspectives is important to improve the childbirth experience. Objective To explore the experiences and preferences of IOL metho...
Article
Full-text available
Objective To evaluate safety, feasibility, and acceptability of a telemedicine medical abortion service without pre‐treatment in‐person tests in Ukraine, Uzbekistan, and Azerbaijan. Methods We conducted an open‐label, prospective, observational clinical study at five clinics in the three countries. Interested and eligible participants scheduled a...
Article
Full-text available
Objective To assess whether, in those requiring continuing uterine stimulation after cervical ripening with oral misoprostol and membrane rupture, augmentation with low‐dose oral misoprostol is superior to intravenous oxytocin. Design Open‐label, superiority randomised trial. Setting Government hospitals in India. Population Women who were induc...
Preprint
Objective : To assess whether, in those requiring ongoing uterine stimulation after cervical ripening with oral misoprostol and membrane rupture, augmentation with low dose oral misoprostol is superior to intravenous oxytocin. Design: Open-label, superiority randomised trial Setting: Government hospitals in India Population: Women induced with oral...
Article
Full-text available
Background Patient-Reported Outcomes or Experience Measures (PROMS / PREMS) are routinely used in clinical studies to assess participants’ views and experiences of trial interventions and related quality of life. Purely quantitative approaches lack the necessary detail and flexibility to understand the real-world impact of study interventions on pa...
Conference Paper
Full-text available
Objective: To understand what is important to women undergoing induction of labour for hypertension in pregnancy, before and after birth. Design: Novel, longitudinal mixed-methods evaluation tool, within a randomised controlled trial. Method: The PaGES (Participant-Generated Experience and Satisfaction) Index was completed by 520 women in a rando...
Article
Introduction: Prior studies indicate that PAPP-A could serve as a marker of gestational age (GA) with the potential to determine eligibility for medication abortion. The authors validated the relationship between PAPP-A and GA in an actual-use population. Materials & methods: The authors collected blood samples, medical histories and ultrasound-det...
Article
Full-text available
Objective: Given the substantial barriers to abortion access in the US, many clinics now mail patients abortion medications. We examined whether dispensing the medications by mail prolonged time to medication use. Methods: We analyzed data from no-test medication abortions with medication provided either by mail or in a clinic from 11 US clinics...
Article
Objective: To assess the feasibility and acceptability of misoprostol as a treatment option for incomplete abortion in secondary hospitals in Yangon and Mandalay, Myanmar. Methods: An explanatory sequential mixed methods study was conducted. Women seeking treatment for an incomplete abortion with a uterine size <12 weeks were eligible to partici...
Article
A retrospective study of abortion facilities in and around Texas by White et al.¹ and a spatial analysis by Rader et al.² are combined to illustrate the detrimental effects of abortion bans enacted in the United States.
Article
Objectives We conducted a pilot study to evaluate a single dose of letrozole 30 mg prior to misoprostol 800 mcg buccally for medication abortion Study design We enrolled 40 participants seeking medication abortion up to 63 days’ gestation at a site in Salt Lake City, UT. Participants received a single dose of letrozole 30 mg in-clinic followed 2 d...
Article
We are grateful to Drs. Johnson, Genzen, Algeciras-Schimnich, Bornhorst, and Lambert-Messerlian for their careful read of our paper (1). We fully agree that our data “do not currently support the clinical use of PAPP-A to estimate gestational age,” specifically using automated methodologies for measuring pregnancy-associated plasma protein A (PAPP-...
Article
Full-text available
Importance: Screening for medication abortion eligibility typically includes ultrasonography or pelvic examination. To reduce physical contact during the COVID-19 pandemic, many clinicians stopped requiring tests before medication abortion and instead screened patients for pregnancy duration and ectopic pregnancy risk by history alone. However, fe...
Article
Objective Medical menstrual regulation (MMR) may offer a promising way to reach Senegalese women and girls in need of fertility management, especially in rural contexts. To assess the feasibility of introducing a MMR service in Senegal, the study aimed to 1.) understand how women and girls manage their menses and fertility, and 2.) document accepta...
Article
Post-sedation escort policies are not evidence-based but traditional consensus recommendations made by professional societies. As people travel further for abortion care, escort policies are increasingly difficult to navigate and force people to delay care, compromise privacy, or undergo procedures without sedation. At worst, clinics may turn away...
Article
Full-text available
Objectives Induction of labour (IOL), or starting labour artificially, can be a lifesaving intervention for pregnant women and their babies, and rates are rising significantly globally. As rates increase, it becomes increasingly important to fully evaluate all available data, especially that from low income settings where the potential benefits and...
Article
Full-text available
Pharmacies in low- and middle-income countries play an important role in increasing the availability of medical abortion to individuals for self-use. We aimed to document the costs to users of medical abortion products at outlets across geographies and understand the diversity of available products, primarily in low- and middle-income countries or...
Article
Background Accurate pregnancy dating is critical for maternal and child health and for counseling on safe and effective abortion methods. While last menstrual period and first trimester ultrasound are often used together to determine gestational age (GA), they have limited accuracy and availability, respectively. Prior studies have shown that pregn...
Article
Full-text available
Background Every year approximately 30,000 women die from hypertensive disease in pregnancy. Magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. Low dose oral misoprostol, a prostaglandin E1 analogue, is a highly effective method for labour induction. Usually, once active labour has commenced, the misoprostol...
Article
Objective : To develop a minimum data set, known as a core outcome set, for future abortion randomized controlled trials. Study design : We extracted outcomes from quantitative and qualitative systematic reviews of abortion studies to assess using a modified Delphi method. Via email, we invited researchers, clinicians, patients, and healthcare org...
Article
Objectives To compare outcomes among patients who did or did not have pre-abortion ultrasound or pelvic exam before obtaining medication abortion (MA) via direct-to-patient telemedicine and mail. Study Design We analyzed data from participants screened for enrollment into the TelAbortion study at five sites from March 25-September 15, 2020. We com...
Article
Introduction The COVID-19 pandemic brought new attention to medication abortion because it does not require direct physical contact between patient and clinical staff. No-test approaches for medication abortion preserve the usual standard of care, except that they replace the in-person ultrasound or physical exam before the abortion with other evid...
Article
Objective : To present updated evidence on the safety, efficacy and acceptability of a direct-to-patient telemedicine abortion service and describe how the service functioned during the COVID-19 pandemic. Study Design : We offered the study at 10 sites that provided the service in 13 states and Washington DC. Interested individuals obtained any ne...
Article
Full-text available
Objective We aimed to determine the risk of postpartum infection and increased pain associated with use of condom-catheter uterine balloon tamponade (UBT) among women diagnosed with postpartum hemorrhage (PPH) in three low- and middle-income countries (LMICs). We also sought women’s opinions on their overall experience of PPH care. Methods This pr...
Article
Full-text available
Objective To evaluate the safety and feasibility of a Family First Aid approach whereby women and their families are provided misoprostol in advance to manage postpartum hemorrhage (PPH) in home births. Methods A 12-month prospective, pre-post intervention study was conducted from February 2017 to February 2018. Women in their second and third tri...
Article
Full-text available
Background Misfolded proteins in the urine of women with preeclampsia bind to Congo Red dye (urine congophilia). We evaluated a beta prototype of a point-of-care test for the identification of urine congophilia in preeclamptic women. Methods Prospective diagnostic case-control study conducted in 409 pregnant women (n = 204 preeclampsia; n = 205 un...
Article
Objective: Missed period pills (MPP) are uterine evacuation medications used for treatment of delayed menses without prior pregnancy confirmation. This study explores potential interest in missed period pills in two US states. Study design: We enrolled people seeking pregnancy test services at nine health centers in two US states between June 20...
Article
( Lancet . 2019;394:1011–1021) Hypertension complicates ∼10% of pregnancies, and is associated with adverse outcomes for the mother and child. Severe hypertension in pregnancy, defined as a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥110mm Hg, is considered an obstetric emergency requiring urgent antihypertensive treatment to pr...
Article
( BJOG . 2019;126:1612–1621) The World Health Organization has recommended uterine balloon tamponade (UBT) as one intervention for postpartum hemorrhage (PPH), a leading cause of maternal mortality worldwide. This is important for low- and middle-income countries (LMICs), where uterotonics, blood products, and skilled surgical teams may not be read...
Article
Full-text available
Background: Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide. In Afghanistan, where most births take place at home without the assistance of a skilled birth attendant, there is a need for options to manage PPH in community-based settings. Misoprostol, a uterotonic that has been used as prophylaxis at the household l...
Article
Full-text available
Background: Previous community-based research shows that secondary prevention of postpartum hemorrhage (PPH) with misoprostol only given to women with above-average measured blood loss produces similar clinical outcomes compared to routine administration of misoprostol for prevention of PPH. Given the difficulty of routinely measuring blood loss f...
Article
Objective To explore hCG patterns using multi-level urine pregnancy tests (MLPTs) among prenatal clients to evaluate the potential use of these tests for medical abortion follow-up after 63 days’ gestation. Study Design Prenatal clients with gestations 9-12 weeks were asked to administer an MLPT weekly for three weeks. We evaluated change in hCG ra...
Article
Full-text available
Objective To characterise the occurrence of fever (≥38.0°C) after treatment for post‐partum haemorrhage (PPH) with sublingual misoprostol 800 mcg in Latin America, where elevated rates of misoprostol’s thermoregulatory effects and recipients’ increased susceptibility to high fever have been documented. Methods A prospective observational study in...
Article
Full-text available
Background: Oral tranexamic acid (TXA), if effective in reducing blood loss after delivery for women experiencing primary PPH, could be administered where parenteral administration is not feasible. This trial assessed the efficacy, safety, and acceptability of oral TXA when used as an adjunct to sublingual misoprostol to treat postpartum hemorrhag...
Article
Objective To evaluate whether fetal and placental expulsion is more likely within 48 hours if women receive mifepristone pre-treatment versus placebo pre-treatment followed by misoprostol 200mcg buccally for treatment of fetal death at 14 weeks 0 days to 28 weeks and 6 days gestation. Study Design: We randomized 176 women with a confirmed fetal dea...
Article
Objective: To examine the possibility that serum or urine concentrations of pregnancy-associated plasma protein A (PAPP-A), a disintegrin and metalloproteinase 12 (ADAM-12), placental growth factor (PlGF), human placental lactogen (HPL), glypican-3, pregnancy specific beta-1-glycoprotein 1 (PSG-1) or prolactin could predict gestational age (GA) >7...
Article
Objectives: This open-label non-inferiority study assessed efficacy of a common outpatient medical abortion regimen among people with pregnancies 64-70 days and 71-77 days of gestation. Study Design We defined non-inferiority by a 6% margin of method success. People with intrauterine pregnancies 64-77 days' gestational age by abdominal ultrasound...
Article
Full-text available
Objectives: To evaluate the characteristics, clinical information, and storage instructions contained in package inserts from medical abortion commodities collected in low- and middle-income countries. Study design: From November 2017 to February 2018 mifepristone, misoprostol, and combined mifepristone-misoprostol (combipack) products were coll...
Article
The number of people who wish to stop an abortion once it has started is low. There is little evidence-based guidance for clinicians about how to help those few patients who may want to stop an abortion procedure once it has started. This National Abortion Federation Clinical Policies Committee guidance discusses certainty around abortion decision...
Article
(Abstracted from Lancet 2019;394:1011–1121) Hypertension complicates 1 in 10 pregnancies and has been associated with a number of maternal, fetal, and neonatal adverse events. In cases of severe hypertension (defined by a systolic blood pressure [BP] ≥ 160 mm Hg or diastolic BP ≥ 110 mg), urgent antihypertensive treatment is warranted.
Article
Full-text available
Background: Niger has one of the highest maternal mortality ratios in Sub Saharan Africa, of which postpartum hemorrhage is the leading cause. In 2014, Health and Development International and the Ministry of Health of Niger launched an initiative to introduce and scale-up three PPH interventions in health facilities nationwide: misoprostol, uteri...
Article
Full-text available
Objective We assessed the impact of intravenous (IV) infusion versus intramuscular (IM) oxytocin on postpartum blood loss and rates of postpartum hemorrhage (PPH) when administered during the third stage of labor. While oxytocin is recommended for prevention of PPH, few double-blind studies have compared outcomes by routes of administration. Metho...
Article
Full-text available
Objective: Assess the effectiveness of introducing condom-catheter uterine balloon tamponade (UBT) for postpartum hemorrhage (PPH) management in low- and middle-income settings. Design: Stepped wedge, cluster-randomized trial. Setting: Eighteen secondary-level hospitals in Uganda, Egypt and Senegal. Population: Women with vaginal delivery fr...
Article
Objectives: To evaluate the safety, acceptability and feasibility of a one-day outpatient medication abortion service at gestations 13-18 weeks. Study design: Open-label prospective study in which participants received mifepristone 200 mg orally to swallow at home or at the clinic followed 24 h later by misoprostol 400 mcg buccally. They present...
Article
Full-text available
Objective We aimed to better understand how well postpartum blood loss and common postpartum hemorrhage (PPH) definitions (i.e. blood loss ≥500ml = PPH, ≥1000ml = “severe” PPH) correlate with postpartum anemia and fall in hemoglobin. Methods Secondary analysis of data from three randomized trials that objectively measured postpartum blood loss and...
Article
Full-text available
Background: Hypertension is the most common medical disorder in pregnancy, complicating one in ten pregnancies. Treatment of severely increased blood pressure is widely recommended to reduce the risk for maternal complications. Regimens for the acute treatment of severe hypertension typically include intravenous medications. Although effective, th...
Article
Introduction We aimed to assess the feasibility and acceptability of a second-trimester medical abortion regimen using mifepristone and sublingual misoprostol with no maximum number of misoprostol doses in Uzbekistan and Ukraine. Methods This prospective open-label study enrolled 306 women with pregnancies of 13–22 weeks in Uzbekistan (n=134) and...
Article
Full-text available
( Am J Obstet Gynecol . 2018;219(2):162–168) Prevalence estimates for postpartum hemorrhage (PPH) vary in the literature from 1% to 10% of all deliveries with PPH responsible for >80,000 deaths worldwide in 2015. The most commonly accepted definition of PPH is based on the amount of blood lost after birth. The World Health Organization defined PPH...
Article
Objectives: To evaluate the safety, feasibility, and acceptability of a direct-to-patient telemedicine service that enabled people to obtain medical abortion without visiting an abortion provider in person. Study design: We offered the service in five states. Each participant had a videoconference with a study clinician and had pre-treatment lab...
Article
Objectives: Current service delivery models for second-trimester medical abortion typically include routine inpatient admission and overnight stays. To assess the feasibility of a day-service model, we evaluated outpatient administration of abortion medications and analyzed the proportion of clients who could avoid an overnight stay. We also exami...
Article
Objective: To compare efficacy, safety/side effects and acceptability of buccal versus sublingual administration of a misoprostol-only regimen commonly used for early medical abortion. Study design: We conducted a randomized trial at six clinics in two Latin American countries. We randomized women seeking early abortion to buccal or sublingual a...
Article
Full-text available
Objective To explore the clinical and programmatic feasibility of using 800 μg of sublingual misoprostol to prevent and treat postpartum hemorrhage (PPH) during home delivery. Methods The present double‐blind randomized controlled trial included women who underwent home deliveries in Chitral district, Khyber Pakhtunkhwa province, Pakistan, after p...
Article
Full-text available
Background Oxytocin for postpartum hemorrhage (PPH) prophylaxis is commonly administered by either intramuscular (IM) injection or intravenous (IV) infusion with both routes recommended equally and little discussion of potential differences between the two. This trial assesses the effectiveness and safety of 10 IU oxytocin administered as IM inject...
Data
Table S1. Unit costs of healthcare resource utilisation.
Data
Figure S1. CONSORT flow chart for the study.
Data
Table S2. Comparison of healthcare costs for Foley catheterisation and oral misoprostol 25 mcg.
Article
Full-text available
Objective To assess the feasibility of using an at‐home multilevel pregnancy test (MLPT) and interactive voice response (IVR) call‐in system for remote follow‐up of medical abortion. Methods A prospective pilot study was conducted among women who had a medical abortion at up to 70 days at a clinic in Mexico City, Mexico, between June 1, 2015, and...
Article
Introduction Management of severe hypertension in pregnancy requires prompt treatment – most commonly with intravenous medications. This strategy presents significant barriers to care, particularly in low resource environments. Objective To compare the effectiveness of three oral antihypertensive regimens in pregnant women with severe hypertension...
Article
Between 62,000 and 77,000 women die annually from pre-eclampsia/eclampsia. Prompt delivery, preferably by the vaginal route, is vital for good maternal and neonatal outcomes. Two low cost interventions -low dose oral misoprostol tablets and transcervical Foley catheterisation- are already used in low resource settings. In this open label, parallel...
Article
Full-text available
Background Magnesium sulfate is the preferred pharmacological intervention for the prevention and treatment of eclamptic seizures in pregnancy. Pain associated with intramuscular injections and the need for an electronic infusion pump for use intravenously represent significant barriers to broader utilization. We hypothesize that an alternative reg...
Article
( Lancet . 2017;390(10095):669–680) Hypertensive disorders, including preeclampsia, affect 10% of all pregnancies, with preeclampsia and eclampsia accounting for roughly 14% of global maternal deaths annually. While treatment with magnesium sulfate or antihypertensive drugs can reduce maternal morbidity and mortality, the best preventive method is...
Article
Full-text available
Objective: To determine the effectiveness and economic impact of two methods for induction of labour in hypertensive women, in low-resource settings. Design: Cost-consequence analysis of a previously reported multi-centre, parallel, open-label randomized trial. Setting & population: 602 women with a live fetus, aged>18 years requiring delivery...
Article
The current definition of postpartum hemorrhage (PPH) is inadequate for early recognition of this important cause of maternal mortality, responsible for more than 80,000 deaths worldwide in 2015. A stronger definition of PPH should include both blood loss and clinical signs of cardiovascular changes after delivery, which would help providers to mor...