This research seeks to demonstrate that a telemedicine model for the provision of legal abortion services in Ecuador is safe, feasible and acceptable to users requesting a medication abortion and who are less than 12 weeks pregnant.

Start Date24 Jul 2024

Sponsor / Collaborator

Gynuity Health Projects, Inc.

NCT06492889 / Not yet recruitingPhase 2/3

Randomized Trial Comparing Progestin With Mifepristone Versus Mifepristone Alone for Use as Missed Period Pills

The goal of this trial is to examine the efficacy and acceptability of two medication regimens at inducing a return of menses when used 2-8 days after a missed period. The first regimen consists of one dose of 1.5 mg levonorgestrel followed one to two days later by one dose of 200 mg mifepristone. The second regimen will consist of one dose of a placebo pill, followed one to two days later by one dose of 200 mg mifepristone.
The investigators will assess and compare the efficacy of both regimens (proportion of women in each group not pregnant at follow-up who were determined to be pregnant at enrollment), and the effectiveness of both regimens (proportion of all participants not pregnant at follow-up among all participants enrolled)

Start Date22 Jul 2024

Sponsor / Collaborator

Gynuity Health Projects, Inc.

NCT05781061 / RecruitingNot Applicable

Medication Abortion With Autonomous Self-Assessment Project at Independent Abortion Clinics: A Demonstration Project

In this study, the investigators propose to conduct a parallel study to MA-ASAP (ClinicalTrials.gov Identifier: NCT05278780) at an independent clinic.

Start Date16 Feb 2023

Sponsor / Collaborator

Gynuity Health Projects, Inc.

100 Clinical Results associated with Gynuity Health Projects, Inc.

0 Patents (Medical) associated with Gynuity Health Projects, Inc.

Literatures (Medical) associated with Gynuity Health Projects, Inc.

01 Jun 2017·Current Obstetrics and Gynecology Reports

Intrauterine Devices and Contraceptive Implants: Overview of Options and Updates on Method Use

Author: E. E. Levi ; M. K. Findley ; M. V. Dragoman

Intrauterine devices (IUDs) and contraceptive implants offer safe and highly effective long-acting reversible contraception (LARC) without requiring routine effort from users. A majority of women who choose these methods report high satisfaction; 12-month continuation rates typically exceed 80%. We summarize some of the latest research and recommendations for use of currently available LARC methods to promote high-quality service delivery. New hormonal LARC methods are available, and research suggests that the duration of contraceptive protection for some existing methods extends beyond current manufacturer instructions. Updated evidence-based guidelines recommend that most women, including women with various medical conditions, can safely use IUDs and/or contraceptive implants. Initiation can be timed to whenever pregnancy is reasonably excluded, and few, if any, examinations or tests are required prior to insertion. We highlight some considerations for the use of these methods by adolescents and by women who are postpartum or breastfeeding and immediately following abortion. LARC methods offer many attractive features to women seeking contraception, and there are a growing number of options available for women to consider. Evidence-based recommendations should guide determinations of medical eligibility. Implementing best practices for safe and effective provision of LARC and optimizing opportunities for contraceptive initiation enables providers to better respond to women’s needs. Access to contraception and family planning, including LARC, is critical to the health and well-being of women, families, and communities worldwide.

01 Nov 2016·Obstetrics & GynecologyQ2 · MEDICINE

Simultaneous Administration Compared With a 24-Hour Mifepristone–Misoprostol Interval in Second-Trimester Abortion

Q2 · MEDICINE

Article

Author: Chi, Huynh Thi Kim ; Nga, Nguyen Thi Bach ; Martin, Roxanne ; Winikoff, Beverly ; Blum, Jennifer ; Abbas, Dina Fatima ; Ngoc, Nguyen Thi Nhu

OBJECTIVE:To compare outcomes with simultaneous administration of mifepristone and misoprostol with a regimen in which the drugs are administered at a 24-hour interval for second-trimester abortion.METHODS:In this placebo-controlled, double-blind trial, participants were randomized to receive mifepristone either 24 hours before or at the same time as misoprostol. Participants were hospitalized to receive 400 micrograms buccal misoprostol at 3-hour intervals up to 48 hours or until uterine expulsion. The primary outcome was the proportion of women who experienced uterine expulsion within 24 hours after the first misoprostol dose and this required 504 women to examine our hypothesis that this rate would be 85% in the 24-hour interval arm compared with 70% in the simultaneous arm. Secondary outcomes included total abortion time from mifepristone and misoprostol.RESULTS:From February 2013 to April 2014, 509 women were enrolled. Women in the 24-hour interval arm were more likely to abort within 24 hours (94.4% compared with 85.0%, relative risk 1.11, 95% confidence interval [CI] 1.05–1.18). At 48 hours, the rate was similar in the two arms (96.8% [24-hour interval] and 95.7% [simultaneous], relative risk 1.01, 95% CI 0.97–1.04). Median misoprostol dosing time was shorter in the 24-hour interval arm (7.7 compared with 13 hours; P<.001) and consistent with the median misoprostol doses required (three compared with five; P<.001). Median time from mifepristone to uterine expulsion was longer in the 24-hour interval arm (32.3 compared with 13 hours; P<.001). Both regimens had high acceptability rates and reported similar side effects and pain scores.CONCLUSION:Administering mifepristone and misoprostol simultaneously results in lower expulsion rates within 24 hours of taking misoprostol, longer median misoprostol treatment times, and requires more misoprostol doses. At 48 hours, both regimens work equally well. Simultaneous dosing results in less total time from the first clinical contact to complete abortion.CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, https://clinicaltrials.gov, NCT01768299.

01 Feb 2016·Obstetrics & GynecologyQ2 · MEDICINE

Vaginal and Rectal Clostridium sordellii and Clostridium perfringens Presence Among Women in the United States

Q2 · MEDICINE

Article

Author: Ingrida Platais ; Heidi E. Jones ; Brandi M. Limbago ; Karmen Louie ; Dyanna Charles ; Erica Chong ; Caitlin Shannon ; Jennifer L. Prentice ; Kathy Agnew ; Beverly Winikoff

OBJECTIVETo characterize the presence of Clostridium sordellii and Clostridium perfringens in the vagina and rectum, identify correlates of presence, and describe strain diversity and presence of key toxins.METHODSWe conducted an observational cohort study in which we screened a diverse cohort of reproductive-aged women in the United States up to three times using vaginal and rectal swabs analyzed by molecular and culture methods. We used multivariate regression models to explore predictors of presence. Strains were characterized by pulsed-field gel electrophoresis and tested for known virulence factors by polymerase chain reaction assays.RESULTSOf 4,152 participants enrolled between 2010 and 2013, 3.4% (95% confidence interval [CI] 2.9-4.0) were positive for C sordellii and 10.4% (95% CI 9.5-11.3) were positive for C perfringens at baseline. Among the 66% with follow-up data, 94.7% (95% CI 88.0-98.3) of those positive for C sordellii and 74.4% (95% CI 69.0-79.3) of those positive for C perfringens at baseline were negative at follow-up. At baseline, recent gynecologic surgery was associated with C sordellii presence, whereas a high body mass index was associated with C perfringens presence in adjusted models. Two of 238 C sordellii isolates contained the lethal toxin gene, and none contained the hemorrhagic toxin gene. Substantial strain diversity was observed in both species with few clusters and no dominant clones identified.CONCLUSIONThe relatively rare and transient nature of C sordellii and C perfringens presence in the vagina and rectum makes it inadvisable to use any screening or prophylactic approach to try to prevent clostridial infection.CLINICAL TRIAL REGISTRATIONClinicalTrials.gov, www.clinicaltrials.gov, NCT01283828.

100 Deals associated with Gynuity Health Projects, Inc.

100 Translational Medicine associated with Gynuity Health Projects, Inc.

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