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Contraception clinical trials

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NCT ID: NCT05909410 Not yet recruiting - Contraception Clinical Trials

Perception About Benefits and Risks Related to Combined Hormonal Contraceptives Use in Patients With Lynch Syndrome

Start date: July 1, 2023
Phase:
Study type: Observational

Combined hormonal contraceptives (CHCs), according to the opinion by The Manchester International Consensus Group, should be considered for women wishing contraception because also positively impact endometrial cancer and ovarian cancer risk. The awareness of the effects of hormonal therapies in women at high risk of developing endometrial cancer, colorectal, breast, or ovarian cancer, such as those affected by Lynch syndrome (LS), is currently limited, with few published studies addressing these populations. Making informed decisions about CHC use in this context necessitates careful consideration of individual cancer risk and the potential benefits and risks associated with CHC use. Accurate information regarding the oncological risks associated with CHC use is essential for facilitating shared decision-making between women and their healthcare providers in this patient population. This prospective study aims to evaluate the knowledge, attitudes, and beliefs of women with LS concerning CHCs and their potential effects on specific disease development and cancer risk, comparing them to the general population. By considering psychosocial factors and individual perceptions of cancer risk, this study seeks to contribute to informed decision-making, personalized counseling, and improved strategies for gynecologic cancer risk management in women with LS.

NCT ID: NCT05904405 Not yet recruiting - Contraception Clinical Trials

Perceived Quality of Family Planning Counselling

Start date: July 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this cross sectional study is to test Perceived quality of family planning counseling and its determinants among females in reproductive age in El-Dakhla District, New Valley government ,Egypt. The main question[s] it aims to answer are: 1. During the contraception consultation, I was able to give my opinion about what I needed. 2. I received complete information about my options for contraceptive methods. 3. The provider knew how to explain contraception clearly. 4. I had the opportunity to participate in the selection of a method. 5. I received information about how to protect myself from sexually transmitted infections. 6. I received information about what to do if a method fails (e.g., broken condom, forget a pill, feel an IUD is poorly placed). 7. I could understand how my body might react to using contraception. 8. I could understand how to use the method(s) we talked about during the consultation. 9. I received information about what to do if I wanted to stop using a method. 10. The provider explained to me what to do if I had a reaction to a method (e.g., allergies, nausea, pains, menstrual changes). 11. I felt the information I shared with the provider was going to stay between us. 12. The provider gave me the time I needed to consider the contraceptive options we discussed. 13. The provider was friendly during the contraception consultation. 14. I felt the health care provider had sufficient knowledge about contraceptive methods. 15. The provider showed interest in my health while we talked about contraception. 16. The provider was interested in my opinions. 17. I felt listened to by the provider 18. The provider pressured me to use the method they wanted me to use. 19. I felt the provider treated me poorly because they tend to judge people. 20. I felt scolded because of my age. 21. The provider made me feel uncomfortable because of my sex life (e.g., when I started having sex, my sexual preferences, the number of partners I have, the number of children I have). 22. The provider looked at me or touched me in a way that made me feel uncomfortable.

NCT ID: NCT05890495 Not yet recruiting - Contraception Clinical Trials

Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement

PAP-AID
Start date: June 2023
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT05818254 Not yet recruiting - Contraception Clinical Trials

The HOP-STEP Intervention: Improving Maternal Health in Women With Lupus sIRB

HOP-STEPsIRB
Start date: May 31, 2024
Phase: N/A
Study type: Interventional

While the HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) program has been demonstrated to be effective in improving provider confidence, increasing contraception documentation, and facilitating equitable pregnancy planning care in a single sub-specialty clinic here at Duke, the delivery of HOP-STEP may need to be changed to increase its fit with the local context at the University of Chicago Medical Center (UCMC) and subsequent locations. Thus, the investigators will now fit the intervention into a high-minority, high-poverty academic rheumatology center, and later pilot it through a randomized trial to identify and overcome existing barriers to equitable pregnancy prevention and planning at another institution (The University of Chicago Medical Center). The objective of this study is to prepare for a multi-center trial of the HOP-STEP intervention by fitting and then piloting its implementation and measuring its potential impact on maternal outcomes.

NCT ID: NCT05675644 Not yet recruiting - Contraception Clinical Trials

Drospirenone-only Pill as Emergency Contraception

Start date: February 2023
Phase: Phase 2
Study type: Interventional

Emergency contraception (EC) provides an additional measure to help prevent pregnancy after unprotected intercourse or contraceptive failure. The two currently available oral emergency contraceptive methods, levonorgestrel (LNG) and ulipristal acetate (UPA), have differing availability and effectiveness. Overweight and obesity are strong risk factors for failure of EC containing LNG and UPA for body mass index (BMI) ≥ 26kg/m2 and ≥35kg/m2, respectively, resulting in limited EC options for much of the population. Drospirenone is a unique progestin that effectively inhibits ovulation when taken daily as progestin-only oral contraception and has pharmacokinetic properties that make it a good candidate for a novel effective emergency contraceptive method across BMI categories. The investigators propose a dose-finding, adaptive-design pilot study evaluating if a single dose of drospirenone can inhibit ovulation prior to the luteinizing hormone (LH) surge. The dose-finding study design will be conducted in a well-established 3+3 model with 2 planned study arms stratified by BMI. The investigators hypothesize that a single dose of drospirenone will effectively inhibit ovulation when administered prior to the LH surge. This pilot data will directly support the dose selection for future research further evaluating the efficacy of drospirenone-only EC aimed at ultimately increasing oral EC options, particularly for patients with overweight or obesity.

NCT ID: NCT05610527 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Hormonal Influences on Inflammatory Bowel Diseases

Start date: December 1, 2024
Phase: N/A
Study type: Interventional

Of the 1.8 million females with inflammatory bowel diseases (IBD) in the US, over half of those who are premenopausal suffer from cyclical menstrual-related IBD symptoms, regardless of how well their disease is controlled. Despite the significant impact that cyclical IBD symptoms, such as abdominal pain, diarrhea, and fatigue have on quality of life, evidence about how to alleviate these symptoms is lacking. In other chronic conditions which are hormonally influenced, such as epilepsy, hormonal contraception may be used to favorably impact disease-related symptoms associated with menses and improve quality of life. In our previous cross-sectional study, 47% of the levonorgestrel intrauterine device users and 19% of combination oral contraceptive users reported improvement in their cyclical IBD symptom. All hormonal methods may plausibly improve symptoms, but prospective, rigorous data evaluating their efficacy for this purpose are lacking. In order to design a future comparative effectiveness trial on the effect of hormonal contraceptive methods on menstrual-related IBD symptoms, we propose this pilot prospective cohort study of 200 females with IBD: 100 naturally cycling and 100 hormonal contraception users. We will gain essential knowledge on IBD-specific influences on contraceptive method selection, willingness to be randomized to methods, the ability of IBD patient reported outcome (PRO) instruments to differentiate between non-menstrual and menstrual-related IBD symptoms, and assess the potential role of inflammatory markers as outcome measures in future trials. We will recruit participants from the University of Utah IBD Center and clinics, other Utah gastroenterology providers, and through social media ads. Total study commitment will be ~12 weeks. Study activities will include daily and weekly text message surveys, as well as blood draws and fecal samples for inflammatory markers in a subset of participants which are commonly used for IBD management. Our aims include: (1) To identify preferences and reasons for contraceptive method selection (or non-use) and willingness to participate in a randomized controlled trial, to inform feasibility of a future trial, (2) To obtain estimates of means and standard deviations for the validated Crohn's Disease and Ulcerative Colitis PRO Instruments by menstrual timing in naturally-cycling participants and between bleeding and non-bleeding days in hormonal contraception users, and (3) To assess correlation between inflammatory marker changes (fecal calprotectin & high sensitivity C-reactive protein), menstrual timing or bleeding/non-bleeding days, and IBD PRO responses, in a subset of 30% of Aim 1 participants. This pilot will inform a future trial design to define non-contraceptive benefits of hormonal contraception on cyclical IBD symptoms. This line of inquiry will allow for an adjuvant approach for IBD symptom management that is sex-specific and addresses both concerns for hormonal triggers and the need for highly-effective contraception for those who desire it.

NCT ID: NCT05355636 Not yet recruiting - Contraception Clinical Trials

The Effects of Fertility Management Counseling Supported With Telehealth on Contraceptive Use

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Fertility management refers to the entirety of practices that allow families to have as many children as they want and when they want, prevent unwanted pregnancies, regulate the time between two births and receive help in having children in the case of infertility. According to the Turkey Demographic and Health Survey 2018 data, 70% of women in Turkey who are currently married do not use any contraceptive method. Based on the same data, the rate of the unmet need for fertility management is 12% nationwide, 14% in eastern provinces, and 17% in women at the ages of 20-24. These rates show that the rates of unmet fertility management needs in Turkey are still not on the desired level. The fact that eastern provinces of Turkey have the lowest rate of modern contraceptive method use as 43% and a high rate of unmet fertility management needs as 14% suggests that it is needed to increase the effectiveness of fertility management counseling and reach more women. In these eastern provinces, especially women living in rural areas do not have easy access to these services due to the high prevalence of adolescent marriages, lack of transportation opportunities, healthcare personnel and healthcare services, and unpredictable weather conditions.

NCT ID: NCT05116371 Not yet recruiting - Contraception Clinical Trials

Control of Bleeding on Nexplanon in Latinx Patients

Start date: December 1, 2021
Phase:
Study type: Observational

In this study, researchers want to find out more about how the Etonogestrel (ENG) contraceptive implant device (also known as Nexplanon) changes people's periods. Study subjects will self select into an exposure group- starting combined hormonal contraceptive pills (COC) on the same day as Nexplanon placement or a "delayed initiation" of COC when/if bleeding concerns develop. Patients will be followed for 12 months.

NCT ID: NCT04915885 Not yet recruiting - Contraception Clinical Trials

Strengthening Contraceptive Counseling in Pakistan

Start date: January 2022
Phase: N/A
Study type: Interventional

High-quality contraceptive counseling can strengthen global efforts to reduce the unmet need for and suboptimal use of modern contraceptives. This study aims to identify a package of contraceptive counseling interventions designed to strengthen existing contraceptive services and determine its effectiveness in increasing clients' level of decision-making autonomy and meeting their contraceptive needs.

NCT ID: NCT04611659 Not yet recruiting - Contraception Clinical Trials

Averting NAS Among Opioid-Using Young Women Receiving MAT Using Buprenorphine

NAS-MIET
Start date: November 2020
Phase: N/A
Study type: Interventional

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.