26 Clinical Trials for Various Conditions
The objective of this study is to test and disseminate tools that drive successful immediate postpartum Long-Acting Reversible Contraception (LARC) implementation. The long-term goal is to reduce unintended pregnancy soon after childbirth by increasing access to immediate postpartum LARC for women who desire it.
This a randomized control trial to identify if patients who desire LARC are more likely to have success receiving the desired form of contraception if it is placed a) during the postpartum hospital stay, either in the immediate or early postpartum period, versus b) during the interval postpartum period as previously done.
Prospective, multi-center, single-arm, open-label, Phase II clinical study to evaluate the effectiveness, device placement, safety, and tolerability of VeraCept to support commencing a Phase III Clinical Study
Primary: To compare rates of immediate postabortal LARC uptake between women exposed to a brief, theory-based, video intervention prior to standard contraceptive counseling and women exposed to standard counseling alone. Secondary: To identify predictors of immediate postabortal LARC uptake among all participants including the role of: * Demographic and reproductive health history variables * Baseline decisional balance, self-efficacy and stage of change for contraceptive initiation
The purpose of the study is to measure whether an education and training intervention for clinicians and contraceptive counselors on long-acting reversible contraception (LARC) will result in greater use of the methods among contraceptive patients.
Contraception after abortion is an important public health issue, as women who have an abortion are at high risk for additional unintended pregnancy. In the context of first trimester medical abortion, the standard of care is to administer long-acting reversible contraception, including the etonogestrel implant (Implanon) and depot medroxyprogesterone acetate (DMPA), at a follow-up appointment after the abortion. The investigators plan to conduct a prospective observational pilot study to evaluate the satisfaction of subjects who have selected either the contraceptive implant or DMPA given on the first day of medical abortion, as opposed to at a follow-up appointment. The investigators will also assess the continuation of DMPA and Implanon at 3, 6, 9, and 12 months after the initial date of administration. In addition, the investigators will assess the total days of bleeding after the abortion, follow-up rate for evaluation of completion of medical abortion, and efficacy of medical abortion. A total of 40 participants will be recruited, 20 who choose Implanon and 20 who choose DMPA. They will be asked to fill out questionnaires during the course of the study, and will be followed for one year. The study duration including data analysis will be two years.
In the proposed study, women aged 18-29 seeking oral or injectable contraception will be offered an opportunity to try LARC instead; the FDA-approved options include two types of intrauterine products and one type of subdermal contraceptive implant. Over a 24 month period, the experiences of LARC users will be compared to the experiences of those opting for their initial short-acting method.
This is a prospective observational cohort study that will include SBHC patients at the 6 participating SBHCs who receive a telehealth reproductive health visit as part of their care. Information will be collected during patient interviews in the follow-up observation period regarding LARC initiation, satisfaction and continuation. Aim 1. Quantify uptake of LARC (contraceptive implant, IUD) within the SBHC network following implementation of telehealth-supported LARC provision. Aim 2: Describe the implementation of telehealth-supported long-acting reversible contraception (LARC) service provision in school-based health centers (SBHCs) using mixed methods. Aim 3: Quantify LARC continuation, as in absolute continuation rate 12 months post-initiation, with analyses also examining continuation at 6 months follow-up period, among LARC initiators within the SBHC network following implementation of telehealth-supported LARC provision. Aim 4: Compare continuation rates across dimensions of telehealth experience.
This pilot study aims to assess the feasibility, acceptability, and effectiveness of using nitrous oxide (N2O) sedation for intrauterine device (IUD) insertions for nulliparous adolescent and young adult women in a primary care clinic setting.
The goal of this clinical trial is to perform a pilot study looking at the benefit of topical anesthetic application to the cervix by tampon prior to intra-uterine device insertion. The main question it aims to answer are: * Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce procedural duration? * Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce pain and improve patient perceptions of the procedure? Participants will place a tampon after dipping the tampon into the study-supplied medication (aqueous lidocaine or saline). Researchers will compare treatment and control groups to see if there is any difference in procedure time, difficulty or patient perceptions.
The investigators aim to perform a qualitative study exploring attitudes and perceived barriers to Long Acting Reversible Contraception (LARC), both implants and IUDs, among adolescent and young adults (AYA) with chronic illness at CHLA. While the literature examining barriers to LARC uptake is growing, its focus has been on older women and women who are not living with chronic illness. There remains a significant gap in the understanding of: 1. What adolescents and young adults from ethnically diverse, economically underserved communities know about LARCs 2. If and how LARCs fit into their considerations and decision making about contraception choices 3. Perceived barriers to LARC among AYA with chronic medical conditions 4. Information, perceptions, experiences that inform choices that may be unique to AYA living with chronic conditions Research Objectives 1. Explore the impact of the experience of living with chronic medical conditions on AYA patient attitudes toward and acceptance of LARCs 2. Identify AYA patient concerns and perceptions related to historical coercion and reproductive injustice experienced by minority communities that may reduce acceptance of LARC 3. Explore the relationship between patients' perception of pediatric subspecialty care providers' attitudes regarding sexual health and contraception guidance and patients' attitudes toward and acceptance of LARC 4. Identify factors related to patient's age, family's values, and medical condition, as well as historical events or legacies that may impact preference of implant vs intra-uterine device (IUD), independent of safety/medical contraindications, if choosing a LARC method. 5. Explore other social, cultural or psychological factors that influence perception and represent barriers to LARC access Hypotheses 1. The impact of chronic illness on AYA sense of bodily autonomy (including self-concept, history of other medical procedures, and concerns around mortality) reduces the attractiveness of LARC methods. 2. The intersectionality of multiple oppressions, including racism, xenophobia, sexism, and historical reproductive coercion and injustice implicitly reduce the attractiveness of LARC methods for AYA patients from minority communities with chronic medical conditions at CHLA. 3. Pediatric subspecialty providers' attitudes about sex, and comfort with providing patient-centered contraception counseling, as perceived by AYA patients, impact AYA patient attitudes towards and acceptance of LARC. 4. Preference of implant vs. IUD is related to patient's age, family values, and type of medical condition, as well as their knowledge of historical events related to contraception in their community, independent of safety/medical contraindications. 5. Additional perceived barriers, including fear or skepticism about LARC conferred by trusted sources of information such as family or social media, reduce the attractiveness and acceptance of LARC by AYA with chronic medical conditions
The overall goal of this study is to refine and pilot test the investigators novel intervention to offer contraception counseling and initiation for hospitalized female adolescents, focusing on long acting reversible contraception (LARC).
The purpose of this study is to measure whether a training and education intervention for clinic staff and young women aged 18-25 on contraceptive methods, including intrauterine devices (IUDs) and the implant, will result in greater contraceptive knowledge and access among students in community colleges.
Under contract to the U.S. Department of Health and Human Services (DHHS), Mathematica Policy Research is conducting an impact study of Healthy Families Healthy Futures in Houston, Texas for a Federal Evaluation of Programs for Expectant and Parenting Youth (PEPY). The impact study will be designed to address three main questions: * Was the program successful in exposing participants to program content, such as information about methods of birth control? * Was the program successful at improving short-term outcomes, such as use of a LARC and intention to space births? * To what extent did treatment youth receive the intended program components?
Recent research suggests that women with substance use disorders may be at a higher risk of unintended pregnancy. There is a paucity of interventions specifically focused on this population. Through using mixed methods, this study proposes to develop a brief peer-led intervention (based on the Health Belief Model) to prevent unintended pregnancies among women entering opioid medication-assisted treatment; to assess acceptability, feasibility and the initial efficacy of the behavioral intervention; and to conduct exploratory analyses to identify the Health Belief Model constructs that are most influential on use of long-acting reversible contraception methods. Future research would include testing the intervention in a larger scale trial and with other populations.
Investigators propose a randomized controlled trial of women taking category D or X medications seen in family medicine, internal medicine or in the Coumadin Clinic. Women in the intervention group will receive an electronic medical record referral for teratogen counseling and contraceptive counseling with a follow up contraceptive provision appointment. The contraceptive counseling will be adapted from The Contraceptive CHOICE Project script and promote the use of the long acting reversible contraception. The women in the control group will also receive an electronic medical record referral and receive the teratogen counseling but only be told that it is important to avoid becoming pregnant. An initial survey will assess contraceptive knowledge and utilization. In addition, there will be telephone survey at 3 months and 6 months to assess contraceptive utilization and continuation.
This project will quantify rates of contraceptive failure when unprotected intercourse occurs 6-14 days prior to initiation of highly effective reversible contraceptives (such as IUD's and Implants).
This study evaluates whether there is an interaction between etonogestrel, the progestin hormone released by the contraceptive implant Nexplanon, and efavirenz, a common medication used to treat HIV. The endpoints measured in this study will help determine if such an interaction leads to decreased contraceptive efficacy of the contraceptive implant.
The investigators are examining if there is a difference in continuation rates of the etonogestrel contraceptive implant between women who have the device placed immediately after delivery, before leaving the hospital, and women who have the device placed at the routine 6-week postpartum visit. There will be 60 subjects total, randomized in a 1:1 ratio, for 30 in each group. All participants will follow-up at the same postpartum clinic 6 weeks after delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to complete a brief survey. The investigators hypothesize that continuation rates of Implanon will be higher in the immediate postpartum placement arm than in the delayed placement arm.
The primary objective of the investigators study is to determine if there is a difference in continuation rates at six months in women who are randomized to have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two possible time periods: Immediate (defined as after delivery of placenta to 72 hours postpartum) or Interval (defined as after 6 weeks postpartum).
The investigators study is a prospective randomized trial of women undergoing the levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods: immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in preparation for a multicenter, prospective randomized study of long-acting reversible contraception in the postpartum period.
Over recent years, military service women have shown increasing interest in utilizing long-acting reversible contraceptives (LARCs; i.e., implants or intrauterine devices, IUDs). While clinically, LARC have been proven safe and effective at preventing pregnancy \& decreasing menstrual symptoms, it is unclear what impact this type of contraceptive may have on physiological responses to extreme environments (heat, cold and high altitude). Additionally, iron deficiency and iron deficiency anemia are prevalent in U.S. military women which likely affect health and performance. There is evidence to suggest that the prevalence of iron deficiency and iron deficiency anemia is lower in women utilizing LARCs, which preserve iron stores, likely due to reduced menstrual blood loss that compounds with each cycle over the course of months. Due to the increasing interest in the utilization of LARCs it is important to understand what, if any, impact these methods of contraception may have on a female Soldier's physiological responses. The overall goal of the present study is to characterize iron status and physiological responses (including but not limited to sweating, skin blood flow, ventilation, and heart rate) to extreme environmental stressors of heat, cold and high altitude (i.e. hypobaric hypoxia) in women utilizing LARCs. Up to thirty-three individuals (n=18 LARCs, n=15 monophasic oral contraceptives) will complete testing visits separated by at least 48 hours for environmental testing visits. During heat stress testing, measures of core body temperature, skin temperature, and sweat rate will be measured during a standardized protocol in hot, humid conditions. During cold stress, measures of body core temperature, metabolic heat production, skin blood flow and temperature (at both distal extremity and proximal body sites) will be assessed in order to better quantify the impact of exogenous sex hormones via LARCs and OCs in volunteers exposed to the cold. Measurements will be obtained during a standardized protocol in cold air (\~90 min; 10°C). For altitude, cardiopulmonary responses will be assessed during rest and exercise during an acute altitude exposure (4300m). Blood samples will be collected throughout the investigation in order to quantify sex hormone concentrations, iron status, and inflammatory biomarkers in response to environmental stressors. The investigators will also utilize laboratory tests (i.e., carbon monoxide (CO) rebreathing technique) and collect blood samples to quantity iron stores in these groups of women. To characterize iron status, the Soldier Performance Health and Readiness (SPHERE) epidemiological data repository will be utilized to quantify the prevalence of iron deficiency and iron deficient anemia diagnoses between women using LARCs and women not utilizing LARCs.
This is a randomized prospective study evaluating the impact of a brief contraceptive education intervention with optional referral for financial counseling on post abortion long-acting reversible contraceptive (LARC) uptake and contraceptive use at three months post abortion.
The purpose of this project is to describe how contraceptive services are currently being delivered to women with medical conditions who seek care in community-based primary care settings, such as family medicine and internal medicine clinical offices.
The primary objective of this study is to test the efficacy of a Motivational Interviewing and Educational Training intervention with immediate linkage to long acting reversible contraception (LARC) (hereafter known as MIET). MIET will be delivered to women of childbearing age (18-44) through the Meharry Addiction Clinic to women residing in Nashville, Tennessee. There are two aims associated with this study. The primary aim is to determine the efficacy of MIET, to promote insertion of LARC among young, urban dwelling, low income women living with OUD and at-risk of unplanned pregnancy. The primary endpoint of this aim are: 1) meeting with a provider regarding initial assessment for LARC, 2) having a LARC implant. Because of potential contraindication for LARC insertion (i.e. obesity) the first endpoint of meeting with a LARC provider is most proximal to aim 1. However, determining the number of willing women that go on to receive the implant is also critical in that it reflects potential decreases in cost to the health care system through reduction of unintended pregnancy and related subsequent NAS in the newborn. The second aim for the study is to utilize qualitative and quantitative data collected for the study to modify the MIET intervention to more effectively meet the needs of the women in the study. Survey data for the study will be collected at baseline, one and six months. Of note, the baseline, one and six month survey data collections will provide potential co-variates to consider in analysis of aim one and two. The primary endpoints however will come from the six month records review. We will gain consent to access records at the baseline consent, and will gather these data from the Meharry Electronic Health Record.
Abstract Background: Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth. Methods: This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided. Discussion: A barrier to postpartum contraception is access to medications and devices. The study removes some access barriers (distance, time, cost) by providing contraception in the home. The community nurses were trained to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town, which is about an hour away by vehicle. Therefore, the study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within three months of childbirth. The potential implications of this study include: nurses may be able to be trained to safely provide contraceptives, including place implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period.