28 Clinical Trials for Various Conditions
In this study, the investigators propose to conduct a parallel study to MA-ASAP (ClinicalTrials.gov Identifier: NCT05278780) at an independent clinic.
Medication abortion is a way of ending a pregnancy using pills. The current FDA-approved regimen for medication abortion uses mifepristone and misoprostol. This study is testing whether a different medication, atorvastatin, followed by misoprostol, can be used to end a pregnancy. Participants at 35-49 days of pregnancy will receive an oral dose of atorvastatin (80 mg) to swallow at the clinic as well as taking atorvastatin (80 mg) daily for six additional days, with a return to clinic on day 8 after initial visit to take a dose of misoprostol (800 mcg). Additionally, follow-up visits will occur on approximately days 3, 8 and 11 for a clinician to perform an ultrasound to see if the abortion is complete.
In this study, the investigators propose to create and pilot-test an asynchronous medication abortion provision service.
This study aims to assess efficacy and safety outcomes of a telehealth model of abortion care. The study will compare efficacy of this model to usual in-clinic care based on published rates. It will also investigate participant acceptability and feasibility of this model of care.
This study aims to evaluate the feasibility, acceptability, and effectiveness of dispensing mifepristone via a mail-order pharmacy. The investigators will recruit patients at up to 10 primary care and internal medicines sites not currently providing abortion services around the country, as well as abortion clinic sites. Patients will go through routine in clinic visits to determine eligibility and then will receive the medications in the mail at their preferred address. The investigators will survey patients 3 and 14 days after the initial clinic visit and interview providers at the end of the study.
This randomized trial will evaluate the effect of adding auriculotherapy (i.e. acupuncture applied to the ear) using either gold beads or Pyonex needles in addition to usual care for the relief of pain and anxiety during medication abortion. The control group will receive placebo auriculotherapy plus usual care. Participants will receive the assigned treatment immediately after they receive their initial abortion medication. The investigators will assess pain and anxiety via text message once daily for four days, and in person at a one-week follow-up visit.
The investigator will perform a multicenter, randomized controlled trial in practices that routinely use transvaginal sonography (TVS) to compare how often clinicians order additional testing prior to medical abortion after the use of either TVS or transabdominal ultrasound (TAS) in medical abortion eligibility assessment. Women will be randomized to receive either TVS or TAS prior to medical abortion. We anticipate enrolling 800 patients receiving care from about 30 providers over 6-8 months. The primary study outcome will be the proportion of women that requires additional evaluation after sonography, prior to determination of medical abortion eligibility. The second primary outcome will be patient satisfaction, determined by a patient satisfaction questionnaire utilizing a visual analog scale.
This is a prospective study to evaluate if successful completion of a medication abortion in patients with very early pregnancy can be detected with a urine pregnancy test at 2 weeks instead of 4 weeks. Additionally, the resolution of pregnancy symptoms in these patients will be characterized. Enrolled participants will take take weekly pregnancy tests and complete weekly questionnaires on their pregnancy symptoms for 4 weeks after their medication abortion.
This study will examine the ways in which telehealth for reproductive healthcare affects timing, costs, and follow-up care; whether telehealth reaches people in areas with greater health inequities; and the attributes of telehealth that patients want. Study surveys will be administered to interested, eligible participants: 2,000 patients seeking abortion care will complete the study, comprising of 2 groups: patients seeking medication abortion care either (1) in-person or (2) via telehealth. This project will address how telehealth services can be optimized for people of color, low-income people, and immigrants to increase digital inclusion and health equity.
The investigators are conducting a study on pain control for dilation and curettage (D\&C). Participants are eligible to enroll if they are a planning to have a D\&C in a participating clinic. The investigators are studying how different ratios of medication to liquid affect pain when injected around the cervix. Both potential methods use the same dose of medication, though researchers would like to know which one works better. To be in this study, participants must be over the age of 18 with an early pregnancy loss or undesired pregnancy measuring less than 12 weeks gestation undergoing D\&C while awake in clinic.
This mixed-methods study follows a prospective cohort of patients receiving Mifeprex ® (mifepristone) for medication abortion dispensed by pharmacists after undergoing standard clinical evaluation. Women participating in this study will obtain mifepristone and misoprostol from the pharmacy instead of in the clinic. To assess feasibility, acceptability, and effectiveness of pharmacy dispensing of mifepristone, the study will survey patients, evaluate their clinical outcomes from electronic health records, and survey and interview pharmacists at study sites.
The investigators will study the feasibility of using 90mg ulipristal acetate, a selective progesterone receptor agonist, as an adjunct to 800mcg vaginal misoprostol for the medical management of early pregnancy loss. Patients will be followed to assess effective treatment of early pregnancy loss, additional interventions needed, side effects, adverse events and patient acceptability.
First trimester miscarriages are common. When the failed pregnancy does not pass spontaneously on its own, it is called a missed abortion. There are several ways in which missed abortions are managed, one of which involves administering a medication called misoprostol which causes uterine contractions inducing expulsion of the failed pregnancy. Misoprostol can be administered in multiple ways but has been traditionally inserted vaginally when used for management of missed abortions. Some studies have shown that some women are not comfortable with vaginal insertion of misoprostol and prefer oral administration. Buccal misoprostol is a way of administering misoprostol by having the patients insert the tablets of misoprostol between their gum and cheek, letting it dissolve for 30 minutes, then swallowing the remaining remnants. Buccal misoprostol is used safely in medical abortion. In fact a study by Fjerstad et al (2009), found a decrease in infection rate for medical abortion when misoprostol administration was switched from vaginal to buccal route combined with routine administration of doxycycline. The efficacy of using buccal misoprostol to treat missed abortions has not been studied previously to the investigators' knowledge. In this pilot study, investigators aim to test the hypotheses that buccal misoprostol is equally effective as vaginal misoprostol in the medical management of early pregnancy loss. As secondary outcomes, investigators suspect that buccal misoprostol may be associated with higher rates of gastrointestinal side effect but that patient satisfaction will remain equally as high for buccal misoprostol as for vaginal misoprostol.
With sensitive urine pregnancy tests, women are now able to confirm very early pregnancies. However, approximately one third of abortion facilities do not offer abortions at less than six weeks of pregnancy. Providers may be concerned that they will be unable to identify products of conception (POCs) in uterine aspirates after early abortion and about the time, cost and risk associated with following serum hCG levels when completed abortion cannot be confirmed by gross inspection. Many providers believe that manual vacuum aspiration (MVA) causes less destruction of pregnancy tissue and therefore may increase the likelihood of identifying POCs on gross inspection. No published reports specifically compare MVA to electric vacuum aspiration (EVA) for the detection of complete products of conception and none compare MVA and EVA at less than 6 weeks of pregnancy. We, the investigators, propose to conduct a randomized controlled trial comparing the sensitivity of MVA to EVA for the detection of completed abortion in 500 women with pregnancies of less than 6 weeks gestation at a large inner city family planning center. We will measure positive identification of POCs on gross inspection in patients subsequently shown to have completed abortions. We hypothesize that the rate of true positive detection of POCs will be higher in dilation and curettage (D\&C) using MVA than EVA.
SprmPik AI Assisted Sperm Selection Study SiD, an assistant for sperm selection during intracytoplasmic sperm injection in medically assisted reproduction: effect on fertilization, blastocyst formation, early pregnancy loss, and consistent practice. A prospective pilot study.
A pilot cohort study to preliminarily investigate the efficacy of pretreatment with letrozole 10 mg daily for three consecutive days followed by treatment with misoprostol 800 mcg vaginally for medical management of early pregnancy loss in a US population. Patients will be followed to assess efficacy of this treatment regimen, as well as additional interventions needed, side effects, adverse events, and patient acceptability.
The study assesses the accuracy of cell-free DNA (cfDNA) analysis in detecting whole chromosomal aneuploidies from maternal plasma of patients with early, missed miscarriage.
This study aims to determine the effect of the Healthwise decision aid on shared decision making in women undergoing management of early pregnancy loss.
The goal of this project, Conversational Artificial Intelligence (AI) to Improve PeRiconception Care Access (CIRCA), is to engage patients in care early in pregnancy (before prenatal care starts) and safely triage concerns to PEACE to reduce unnecessary emergency department visits.
A Phase 3, multi-center clinical trial of a CCT-102 regimen or expectant management to promote uterine evacuation in first trimester non-progressing Delayed Pregnancy Loss (DPL).
Background: The North Carolina Early Pregnancy Study (EPS) was held from 1982 to 1986. Women who were trying to get pregnant took part in the study. They collected urine samples. They kept diaries. They filled out surveys. They answered questions about their partners. They were asked about their drug use. Data about air pollution and other exposures were also collected. A follow-up study was held from 2010 to 2011. Researchers want to use the data and samples to study factors that affect reproductive success. Objective: To examine behavioral and environmental exposures and reproductive health, such as menstrual cycles, conception, pregnancy loss, and pregnancy outcomes. Eligibility: The 221 healthy women age 21-42 who were planning to get pregnant and took part in the 1982-86 North Carolina EPS at the time they stopped using all birth control. A 2010-11 follow-up included 173 of these women. Design: This study uses existing data. No new data will be collected in this study. Stored urine samples may be used. Data from surveys and other sources will be used. All of the women who gave data and samples will be included. Electronic data is held in secure databases. The data is kept on computers that are password protected. Hard-copy data are stored in locked file cabinets. The study will take place at more than one site. Data will be shared with groups outside the NIH....
Background: - The purpose of the 1982 1986 North Carolina Early Pregnancy Study was to determine how often pregnancy loss occurs before women know they are pregnant. Women planning to become pregnant were asked to collect daily urine specimens and fill out daily diaries of their intercourse and menstrual bleeding. Researchers are interested in re-contacting this cohort to gather new information and to examine how accurately women can recall events that occurred earlier in their lives. Objectives: - To follow-up with and gather additional information from women who were involved in the Early Pregnancy Study. Eligibility: - Women who participated in the 1982 1986 North Carolina Early Pregnancy Study. Design: * Participants will receive and complete a questionnaire that includes the following topics: * Their pregnancy history. * The infant s birth, including method of delivery and induction of labor. * Early life exposures such as their own birth weight and their parents ages at their birth. * Tap water use during their attempt to conceive * General description of their behaviors during their participation in the original study, these include: physical activity, caffeine, alcohol, and soy food consumption. * Participants will return the surveys to the researchers in the stamped envelope provided with the questionnaire....
Breast pain following second-trimester abortion is common. Breast engorgement and milk leakage following second-trimester perinatal loss and abortion can cause both physical pain and emotional distress. Dopamine agonists have previously been shown to be effective in lactation inhibition for third-trimester fetal/neonatal loss or contraindications to breastfeeding. The investigator's prior work demonstrated that compared to placebo, a single dose of cabergoline was effective in preventing breast symptoms after abortion or loss 18-28 weeks. As lactogenesis starts as early as 16 weeks gestation, the investigators hope to determine the efficacy of cabergoline earlier in the second trimester,16-20 weeks.
This study will use thromboelastometry in ED patients with vaginal bleeding, as well as healthy pregnant controls, to determine if abnormal results are associated with the presence of vaginal bleeding as well as later complications during pregnancy.
The purpose of the study is to examine the impact of doula support for women undergoing a manual vacuum aspiration (MVA) for an early pregnancy failure or undesired pregnancy.
The purpose of this study is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment with women completing daily journals for up to 12 months while trying to conceive and weekly through pregnancy if it occurs.
Use of Juice Plus+ food supplements, when initiated in the first trimester and used continuously thereafter, will result in a lower incidence of preeclampsia and pregnancy complications. This is a prospective randomized and blinded placebo controlled study sponsored by NSA, LLC of Memphis, TN.
The purpose of the study is to compare the effectiveness of combination treatment (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol (standard of care) for the management of early pregnancy failure.