Carolyn Westhoff's research while affiliated with Columbia University and other places
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Publications (352)
Purpose:
We examine the use of transvaginal sonography in imaging ovarian follicles among non-pregnant reproductive-aged women enrolled in a contraceptive clinical trial.
Methods:
Ten sites conducted a clinical trial comparing three oral ulipristal acetate regimens for ovulation inhibition. Enrollees underwent twice weekly transvaginal sonograph...
Objective
: To estimate the effects on cervical mucus, ovarian activity and theoretical contraceptive protection of a 6-hour delay and of missing one norgestrel 0.075 mg progestogen-only pill (POP).
Study Design
: In a prospective, two-site, randomized, crossover study, healthy women aged 18-35 with BMI <32.0 kg/m² and regular ovulatory cycles com...
Objective
To evaluate the bleeding patterns of a new combined oral contraceptive containing estetrol (E4) 15mg/drospirenone (DRSP) 3mg in a 24/4-day regimen.
Study design
We pooled bleeding data from two parallel, open-label, 13-cycle phase 3 trials that enrolled participants 16–50 years old with body mass index (BMI) ≤35 kg/m². Participants repor...
Due to the COVID-19 pandemic, the Sixth International Symposium on Intrauterine Devices and Systems for Women's Health was held as a series of seven two-hour webinars between May 28, 2020, and June 22, 2021. This Symposium featured forty-eight different presenters and moderators covering a wide range of topics to highlight new IUD issues and update...
Objective
Adolescent females in the United States continue to have unmet sexual and reproductive healthcare needs. Research shows that interventions incorporating peer support can augment perceived self-efficacy and reinforce healthy behaviors. Yet, few user-centered digital sexual health interventions incorporate peer support, and aim to change pe...
Objective:
To describe factors associated with subsequent abortions in Colombia and evaluate if post-index-abortion high-efficacy contraceptive availability (IUD) was associated with higher efficacy contraceptive initiation and less subsequent abortion within two years.
Methods:
The study population comprised patients aged 15-44 who underwent in...
To address limitations that exist with existing definitions of menstrual bleeding changes that occur with contraceptive methods, we assembled a panel to develop new recommendations for standardization of bleeding data analyses associated with contraceptive use to better inform users, clinicians, investigators, pharmaceutical companies, and regulato...
Background
Inpatient insertion of long-acting reversible contraception (LARC) and immediate postpartum tubal ligation allow women to initiate highly effective contraception prior to hospital discharge.
Objective
We measured rates of intrauterine device (IUD) and contraceptive implant initiation and tubal ligations performed during delivery hospita...
Purpose
The proliferation of breast epithelial cells increases during the luteal phase of the menstrual cycle, when they are exposed to progesterone, suggesting that ulipristal acetate, a selective progestin-receptor modulator (SPRM), may reduce breast cell proliferation with potential use in breast cancer chemoprevention.
Methods
Women aged 18–39...
Objectives
: To describe ovulation inhibition and safety of daily oral ulipristal acetate (UPA) over 84 days.
Study Design
: This multi-center phase 1/2 trial randomized participants to use oral ulipristal 10 mg or 5 mg daily or a 3-cycle regimen of 5 mg for 24 days followed by four placebo days. We stratified randomization by body mass index (BMI...
Objective
: To explore the effect on ovarian activity and ovulation of 28 days of correct daily use of a progestogen-only pill containing norgestrel 0.075 mg.
Study Design
: We performed a prospective, randomized, cross-over study at two US sites, recruiting healthy women of reproductive age to use norgestrel 0.075 mg daily for three 28-day treatm...
Permanent contraception remains one of the most popular methods of contraception worldwide. This article reviews recent literature related to demographic characteristics of users, prevalence of use and trends over time, surgical techniques, and barriers to obtaining the procedure. We emphasize the patient’s perspective as a key element of choosing...
Background
Adolescent females presenting to emergency departments (EDs) inconsistently use contraceptives. We aimed to assess implementation outcomes and potential efficacy of a user-informed, theory-based digital health intervention developed to improve sexual and reproductive health for adolescent females in the ED.
Methods
We conducted a pilot...
OBJECTIVE
To assess efficacy, cycle control, and safety of an oral contraceptive containing estetrol (E4) 15mg and drospirenone (DRSP) 3mg.
STUDY DESIGN
Women aged 16-50 years with a body mass index ≤35 kg/m² enrolled in this multicenter, open-label, 13-cycle, phase 3 trial evaluating E4/DRSP in a 24-active/4-placebo regimen. Follow-up was schedul...
Objectives
To measure pain and anxiety during first trimester uterine aspiration when using auricular acupressure or acupuncture as an adjunct to usual care.
Methods
This randomized, double-blinded, three-arm trial enrolled patients undergoing an aspiration procedure for an induced abortion, a miscarriage, or other abnormal intrauterine pregnancy....
Background
Increasing access to non-pharmacologic pain management modalities, including acupuncture, has the potential to reduce opioid overuse. A lack of insurance coverage for acupuncture could present a barrier for both patients and providers. The objective of this scoping review was to assess the existing literature on acupuncture insurance cov...
Objectives
To measure pain during first trimester medication abortion using auricular acupressure or auricular acupuncture as an adjunct to pain management. We measured anxiety as a secondary outcome.
Study Design
This randomized, double-blinded, three-arm trial enrolled women seeking medication abortion with mifepristone and misoprostol. Particip...
Background:
Concern regarding pelvic examinations may be more common among women experiencing intimate partner violence.
Objective:
We examined women's attitudes towards pelvic examination with history of intimate partner violence (pressured to have sex, or verbal, or physical abuse).
Design:
Secondary analysis of data from a cluster randomize...
Purpose:
Female adolescents seeking emergency department (ED) care are at high risk of unintended pregnancy, primarily because of contraceptive nonuse; yet, few ED patients follow up for reproductive care when referred. The objective of this cohort study was to determine the feasibility, acceptability, adoption, fidelity, and potential efficacy of...
Introduction
The National Academy of Medicine recommends, and Joint Commission requires, offering non-pharmacologic approaches to pain management, including acupuncture, to reduce opioid overuse in the United States. This study describes 2019 state training requirements to evaluate how they represent opportunities and barriers to increasing access...
Objective
To compare plasma etonogestrel concentrations sampled from the contralateral- versus ipsilateral-to-implant arm.
Study Design
Sub-analysis of a cross-sectional study in Botswana in 33 participants who provided contralateral and ipsilateral blood samples.
Results
Plasma etonogestrel concentrations in contralateral and ipsilateral specimen...
The COVID-19 pandemic has posed challenges for medical education and patient care, which were felt acutely in obstetrics due to the essential nature of pregnancy care. The mobilization of health professions students to participate in obstetric service-learning projects has allowed for continued learning and professional identify formation while als...
Objective:
To evaluate serum estradiol (E2) concentrations during use of 90-day contraceptive vaginal rings releasing E2 75, 100, or 200 mcg/day and segesterone acetate (SA) 200 mcg/day to identify a dose that avoids hypoestrogenism. Study Design We conducted a multicenter dose-finding study in healthy, reproductive-aged women with regular cycles...
Objectives
To evaluate whether etonogestrel concentrations are reduced to a level that could potentially reduce contraceptive efficacy when the etonogestrel contraceptive implant is used concomitantly with dolutegravir-based antiretroviral therapy (ART).
Study Design:
We conducted a non-randomized, open-label, cross-sectional pharmacokinetic study...
Objectives
To evaluate contraceptive effectiveness and safety of oral drospirenone 4 mg 24/4-day regimen in the United States.
Study design
We performed a prospective, single-arm, multicenter phase 3 trial in sexually active women for up to thirteen 28-day treatment cycles. Primary outcome was the Pearl index, calculated using confirmed on-drug pr...
Background:
Prescribing information for the levonorgestrel-releasing intrauterine system allows placement when the clinician is reasonably certain the patient is not pregnant. A six-item checklist aids clinicians in determining pregnancy risk, but may be too restrictive, resulting in delaying placement for many women. Same-day placement, however,...
Objective:
To assess 6-year contraceptive efficacy and safety of a levonorgestrel 52mg intrauterine system (IUS). Study Design We assessed pregnancy rates through 72 months in women aged 16-35 years at enrollment and safety in all participants (aged 16-45 years, n=1751) in an ongoing 10-year phase-3 trial.
Results:
Over six years, nine pregnanci...
Purpose:
Personalized and interactive text messaging interventions may increase participant engagement; yet, how to design messages that retain adolescent attention and positively affect sexual health behaviors remains unclear. The purpose of this study was to identify the characteristics of sexual health text messages perceived as engaging by sex...
Objectives:
To describe bleeding patterns among users of the segesterone acetate (SA) and ethinyl estradiol (EE) contraceptive vaginal system (CVS), and identify factors associated with unscheduled bleeding/spotting (B/S).
Study design:
We pooled results from two multicenter, single-arm, open-label, pivotal, phase 3 studies of the SA/EE CVS cond...
Objective(s):
To describe differences in contraceptive knowledge, attitudes and use among HIV-infected and HIV-uninfected women served by an academic medical center in New York City and to describe gaps in knowledge and practice of gynecologic and HIV clinicians providing care at the same clinic sites where patients completed surveys.
Study desig...
Background:
A ring-shaped, contraceptive vaginal system designed to last 1 year (13 cycles) delivers an average of 0·15 mg segesterone acetate and 0·013 mg ethinylestradiol per day. We evaluated the efficacy of this contraceptive vaginal system and return to menses or pregnancy after use.
Methods:
In two identically designed, multicentre, open-l...
Systematic reviews show that acupuncture can significantly reduce acute and chronic pain. Randomized controlled trials have found that acupuncture significantly decreases post-operative pain scores and the need for opioids to manage pain. Increased access to acupuncture may help reduce the overprescription of opioids. Physician training requirement...
Objective:
The objective was to evaluate the pharmacokinetics (PKs) of levonorgestrel (LNG)-containing combined oral contraceptives (COCs) in obese women.
Study design:
We pooled and reanalyzed data from 89 women with different body mass index (BMI) categories from four clinical studies. The LNG and ethinyl estradiol (EE) PKs were analyzed utili...
Objective:
To evaluate changes in the bone turnover markers CTx and P1NP during 6 months' use of novel continuous contraceptive vaginal rings delivering Nestorone (NES) 200 mcg/day and three doses of estradiol (E2) (10, 20, and 40 mcg/day).
Study design:
This randomized trial enrolled 189 women who used two consecutive vaginal rings over 180 day...
Objective:
This study aimed to evaluate the acceptability of the Woman's Condom (WC) over 6 months (183 days) and ≥6 menstrual cycles in a US-based multicenter open-label phase III contraceptive efficacy trial.
Study design:
We assessed acceptability via written questionnaire at visit 2 (after the third cycle) and visit 3 (after the sixth cycle...
Objectives:
To assess pain-management using auricular acupuncture as an adjunct to ibuprofen and paracervical block during first trimester uterine aspiration, and to assess auricular acupuncture's effect on anxiety.
Study design:
This randomized, double-blinded, three-arm trial enrolled women undergoing uterine aspiration for spontaneous or indu...
The recent Danish cohort study reported a 20% increased risk of breast cancer among current and recent hormonal contraception users. These results are largely consistent with previous studies. This study did not report on stage of disease at diagnosis, and it is not clear to what extent the apparent increased risk may be due to a small advance in t...
Rationale:
More thoroughly understanding the association between elevated depressive symptoms and effectiveness level of contraceptive method selected at a reproductive health visit could help women prevent unintended pregnancy.
Objective:
This study examined how the association between both current and past depressive symptoms and effectiveness...
In this issue of JAMA, Roberts and colleagues¹ report findings from their analysis of abortion-related adverse event rates stratified by facility type. The authors used 2011-2014 data from Truven, a health insurance claims database covering a sample of privately insured people in all 50 states, to compare the rate of additional abortion-related cla...
We report the case of a 21-year-old primiparous woman at 22 weeks gestation who presented with a large uncorrected ventricular septal defect, severe pulmonary hypertension, and Eisenmenger syndrome. The patient elected for termination of pregnancy, which was performed under regional anesthesia. Hemodynamic changes apparently associated with uterine...
The recent Danish cohort study reported a 20% increased risk of breast cancer among current and recent hormonal contraception users. These results are largely consistent with previous studies. This study did not report on stage of disease at diagnosis and it is not clear to what extent the apparent increased risk may be due to a small advance in th...
Objectives:
To compare transabdominal sonography (TAS) to transvaginal sonography (TVS) in medical abortion eligibility assessment; specifically to measure how often clinicians chose to order additional testing for eligibility assessment following TAS and TVS, and to look for differences by patient and clinician characteristics. Also, to compare p...
Objectives:
To evaluate the pharmacokinetic and pharmacodynamic effects of two novel levonorgestrel (LNG)-only contraceptive patches.
Study design:
This multi-center Phase I/II trial randomized participants to use a 7-day transdermal patch designed to deliver a 40 mcg or 75 mcg daily LNG dose for 11 consecutive weeks; randomization was stratifie...
Background:
As part of a program to develop a novel estradiol-releasing contraceptive vaginal ring (CVR), we evaluated the pharmacokinetic (PK) profile of CVRs releasing segesterone acetate (Nestorone® (NES)) combined with one of three different estradiol (E2) doses.
Study design:
A prospective, double-blind, randomized, multi-centered study to...
Objectives:
Self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA-sc) is feasible, acceptable, and effective. Our objective was to compare one-year continuation of DMPA-sc between women randomized to self-administration versus clinic administration.
Study design:
We randomized 401 females ages 15-44 requesting DMPA at clini...
Purpose:
To evaluate the feasibility and acceptability of a text messaging intervention to increase contraception among adolescent emergency department patients.
Methods:
A pilot randomized controlled trial of sexually active females aged 14-19 receiving 3 months of theory-based, unidirectional educational and motivational texts providing reprod...
The progesterone receptor modulator, Ulipristal acetate (UPA) has proven to be an effective emergency contraceptive. Conflicting data has been reported that suggests different efficacy of the drug in different populations, which may be explained by the systemic exposure to the drug. A UPLC–MS/MS method was developed and validated for the accurate a...
This Sounding Board article argues against the need for the currently required Risk Evaluation and Mitigation Strategy (REMS) for the drug Mifeprex for abortion, given the very low rate of adverse events associated with its use.
Objective
This study compares the pharmacokinetics (PK) of levonorgestrel (LNG) emergency contraceptive (EC) and ulipristal acetate (UPA)-EC between normal-body mass index (BMI) and obese-BMI women.
Study design
This prospective, randomized crossover study evaluates the PK of women after single doses of LNG-EC (1.5 mg) and UPA-EC (30 mg). Study pr...
Objectives:
Venous thromboembolism (VTE) risk increases within months of combination oral contraceptive (COC) initiation. Because elevated endogenous thrombin potential (ETP) has been found in several studies to be a VTE risk factor, we evaluated the extent of ETP changes during the initial cycle of an ethinyl estradiol (EE) and levonorgestrel (LN...
Objective:
The gold standard for measuring oral contraceptive (OC) pharmacokinetics is the 24-h steady-state area-under-the-curve (AUC). We conducted this study to assess whether limited sampling at steady state or measurements following use of one or two OCs could provide an adequate proxy in epidemiological studies for the progestin 24-h steady-...
Objectives:
To obtain more precise and detailed information regarding the bleeding patterns of nomegestrol acetate (NOMAC)/17β-estradiol (E2) and drospirenone/ethinyl estradiol (DRSP/EE) and to identify whether baseline demographic characteristics were associated with unscheduled bleeding, absent scheduled bleeding, or amenorrhea.
Study design:...
Objective:
To compare the effectiveness of 1.0 mg intra-fetal or intra-amniotic digoxin to achieve fetal asystole before second-trimester surgical pregnancy termination.
Methods:
In a randomized trial, women received 1.0 mg transabdominal intra-fetal or intra-amniotic digoxin on the day of laminaria placement before dilation and evacuation betwe...
Background:
Over 15 million adolescents use the emergency department (ED) each year in the United States. Adolescent females who use the ED for medical care have been found to be at high risk for unintended pregnancy. Given that adolescents represent the largest users of text messaging and are receptive to receiving text messages related to their...
Context:
Unintended pregnancy is a universal benchmark for reproductive health, but whether variations reflect differences in measurement and how well measures predict pregnancy outcomes warrant further examination. U.S. and British measures of unintended and unplanned pregnancy offer a useful comparison.
Methods:
Some 220 women seeking pregnanc...
Background:
Obesity has reached epidemic proportions around the world. Effectiveness of hormonal contraceptives may be related to metabolic changes in obesity or to greater body mass or body fat. Hormonal contraceptives include oral contraceptives (OCs), injectables, implants, hormonal intrauterine contraception (IUC), the transdermal patch, and t...
Progestin-only contraceptive methods, including the three-year, single-rod etonogestrel (ENG) implant, may be preferred for obese women to avoid additional estrogen-related thrombosis risk; however, whether obese women receive an ENG sufficient dose to suppress ovulation is understudied. Our analysis expands on the limited information currently ava...
Objectives:
The risk of venous thromboembolism (VTE) is highest during the initial months of oral contraceptive (OC) use. We sought to evaluate the extent of hemostatic variable changes during the initial OC cycle and if such changes are related to systemic ethinyl estradiol (EE2) exposure.
Study design:
Participants provided multiple blood samp...
Objective:
To assess baseline dysmenorrhea and insertion-related pain as predictors of intrauterine device (IUD) removal within 1 year following insertion.
Study design:
System-wide medical record abstraction 1 year after IUD insertion to identify removals and comparison of baseline characteristics (dysmenorrhea, insertion pain) among women with...
Objective:
Bleeding data in contraceptive trials areoftencollected using daily diaries, but data quality may vary due to compliance and recall bias. Text messaging is a widespread and promising modality for data collection.
Study design:
This trial randomized participants 1:1 to use text messages or paper diaries to report on bleeding experience...
Venous thromboembolism (VTE) is rare among young women and is often presumed to occur in the setting of a genetic predisposition or during the use of estrogen-containing combined hormonal contraceptive or to have an unknown cause. This study aims to describe the distribution of VTE risk factors among women with a confirmed VTE.
We identified all wo...
To examine the relationship of ovulation-stimulating drugs to risk of cancers other than breast and gynecologic malignancies.
Retrospective cohort study, with additional follow-up since initial report.
Five US reproductive endocrinology practices.
Among a cohort of 12,193 women evaluated for infertility between 1965 and 1988, a total of 9,892 women...
Long-acting injectable (LAI) forms of preexposure prophylaxis (PrEP) are in clinical trials, generating much hope for HIV prevention. But this is not the first time that an injectable form of preventive medication has emerged: the contraceptive agent depomedroxyprogesterone acetate (DMPA) has an important precedent. DMPA's long journey, its initial...
Unintended pregnancy remains a serious public health challenge in the USA. We assessed the effects of an intervention to increase patients' access to long-acting reversible contraceptives (LARCs) on pregnancy rates.
We did a cluster randomised trial in 40 reproductive health clinics across the USA in 2011-13. 20 clinics were randomly assigned to re...
The pelvic examination is under scrutiny given revised cervical cancer screening guidelines. Recent studies have examined physician attitudes and practices, but data are scarce on women's preferences. General mistrust of medical care is higher among Hispanics and blacks, but we know little about attitudes toward the pelvic examination by race and e...
Evaluate the levonorgestrel pharmacokinetics in nonobese and obese women after placement of LNG20 intrauterine contraceptive at 3 years of use.
In a clinical trial to evaluate the LNG20 intrauterine contraceptive for contraception, levonorgestrel plasma concentrations were determined in 279 participants at the 36-month visit. Blood samples were col...
To assess 3-year data on the efficacy and safety of a new 52-mg levonorgestrel intrauterine contraceptive (LNG20) designed for up to 7 years use.
Nulliparous and parous women aged 16-45 years at enrollment with regular menstrual cycles and requesting contraception were enrolled in an open-label, partially randomized trial to evaluate LNG20. The pri...
Female adolescents at high pregnancy risk frequently visit the emergency department (ED) and lack primary providers. It is unclear if current methods of ED referral are successful. The objective of this pilot study was to assess the potential effect and feasibility of a standardized, enhanced method of referral of sexually active females from an ED...
This study was conducted to compare single-dose pharmacokinetics of ethinyl estradiol in an oral contraceptive to steady-state values, and to assess whether any simpler measures could provide an adequate proxy of the 'gold standard' 24-hour steady-state area-under-the-curve. Identifying a simple, less expensive, measure of systemic ethinyl estradio...
Pregnancy rates in US contraceptive clinical trials are increasing due to decreased treatment compliance. This study compared compliance with a new low-dose levonorgestrel (LNG) and ethinyl estradiol (EE) contraceptive patch (CP, Twirla™) with that of a low-dose combination oral contraceptive (COC) in a demographically diverse population.
This anal...
To evaluate skin irritation and patch adhesiveness of a new weekly low-dose levonorgestrel (LNG) and ethi