Treatment Trials

19 Clinical Trials for Various Conditions

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UNKNOWN
The Blossom Project: "BlossomUP" Methods to Decrease Sedentary Time in Pregnancy
Description

Multiple studies have demonstrated a very low prevalence of women meeting physical activity and weight gain recommendations during pregnancy. Additionally, previous Blossom Project studies have shown that when pregnant women engage in a 20 minute walk each day, they spend significantly more time sitting in addition to longer bouts of sitting resulting in increased total sedentary time. We are going to test which method works best to decrease sitting time, and how those methods effect metabolic parameters such as insulin resistance and blood glucose. This study will consist of three groups, each utilizing a commercially available fitness tracker, Fitbit. Group 1 (SR): will reduce sedentary time by interrupting prolonged sitting. Group 2 (WALK): will reduce sedentary time via walking. Group 3 (UC): will continue on with their normal daily routine; usual care.

COMPLETED
Study of Time to Pregnancy in Normal Fertility
Description

The purpose of this study is to determine how long it takes couples of normal fertility to get pregnant once they begin to try, and whether instruction in fertility awareness can decrease time to pregnancy in these couples.

COMPLETED
A Follow-up of the Early Pregnancy Study Cohort.
Description

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....

RECRUITING
Time-restricted Eating Among Pregnant Females With Severe Obesity
Description

In the United States, severe obesity (body mass index (BMI) ≥ 40.0 kg/m2) affects approximately 10% of females of reproductive age with Black females disproportionately burdened (16%). Severe obesity is a significant predictor of adverse perinatal outcomes including gestational diabetes mellitus, pre-eclampsia, premature birth, and at its most severe, fetal death, birth defects and a three-fold greater risk of maternal mortality - outcomes that also disproportionately affect Black females. Observational studies suggest weight maintenance and even modest body fat loss and altering the maternal metabolic milieu (availability of glucose and lipids) in the gestational period may be important to reducing perinatal health risks among pregnant females with severe obesity. The proposed research aims to assess time-restricted eating in the 2nd and 3rd trimesters of pregnancy to explore the effects on maternal weight, and perinatal health outcomes compared to standard clinical care.

RECRUITING
Time to Move in Pregnancy Hyperglycemia
Description

This randomized controlled crossover trial of 36 pregnant individuals with gestational diabetes (GDM) or gestational glucose intolerance (GGI) will: 1. Determine the effects of physical activity (PA) timing, specifically 30 minutes of moderate intensity walking or stepping in the morning (between 5am-9am, within 30-40 minutes of starting breakfast), versus late afternoon/evening (between 4pm-8pm, within 30-40 minutes of dinner) on glucose across the 24-hour cycle. 2. Explore the potential effects of the timing of PA on sleep and mood state.

ENROLLING_BY_INVITATION
Pregnancy at a Time That Is Happy and Healthy for You
Description

In an effort reduce maternal and infant mortality and health disparities overall, PATH4YOU (Pregnancy At a Time that's Healthy and Happy for You) will be implemented starting in Marion County, and will ultimately be a statewide comprehensive contraceptive access program that ensures that patient-centered counseling and same-day access to no (or low) cost contraception are delivered to women across the state. The goal of this project is to partner with community stakeholders to tailor and implement a patient-centered, comprehensive contraceptive access intervention, the PATH4YOU Bundle. The health center level intervention will consist of three key principles: 1. Pregnancy Intention Screening: Provide training for health care providers and assist in health center implementation of a patient-centered pregnancy intention screening strategy within clinical settings 2. Contraception and Reproductive Health Counseling: Implement the use of a pre-visit patient-centered decision-aid for all patients presenting to a health center for reproductive health care. 3. Same-Day Access to Contraception: Provide training for health care providers and logistical assistance to health centers to implement care consistent with providing patients with their chosen method of contraception the day of patient contact.

COMPLETED
A Prospective Cohort Pilot Study of the Clinical and Molecular Epidemiology of Staphylococcus Aureus in Pregnant Women at the Time of Group B Streptococcal Screening in a Large Urban Medical Center in Chicago, IL USA
Description

Background: Community acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) is an emerging pathogen of the 21st century whose incidence as a cause of local and invasive infections has significantly increased, especially in previously healthy term and near term newborns. The etiology of the increasing incidence of infection in previously healthy term and near-term newborns remains unclear. Hypothesis: 1. The incidence of previously healthy newborns infected with CA-MRSA skin \& soft tissue (SSTI) and invasive infections is higher in those born to mothers colonized with CA-MRSA. 2. Pregnant women colonized with CA-MRSA are at higher risk for post-partum infection with this organism. Specific Aims: 1. To determine the incidence of nasal and vaginal colonization with CA-MRSA in pregnant women and determine the genetic similarities of these strains. 2. To study CA-MRSA transmission dynamics and evaluate the incidence of SSTI and invasive infections in newborns born to S. aureus colonized mothers. 3. To study the efficacy of attempted decolonization in CA-MRSA colonized mothers in decreasing the incidence of transmission and development of SSTI and invasive infections in their infants during the first month of life. Potential Impact: Understanding the epidemiology of the transmission dynamics of CA-MRSA in previously healthy newborns will provide important information to support the development of strategies aimed at the interruption of transmission and prevention of infection caused by CA-MRSA in newborns, as well as in pregnant women. This will also allow for the development of infection control strategies to prevent the spread of this organism among post-partum units and nurseries.

RECRUITING
Anticoagulation Profile in Pregnant Women Treated with Three Times a Day of Low Molecular Weight Heparin (LMWH)
Description

Pregnancy is associated with a increased risk of developing blood clots. There is nearly a 5 times greater risk of developing a blood clot in pregnancy. Lovenox is a medication that helps to prevent the body from developing clots. It is safe to use in pregnancy. Previous studies have demonstrated that despite recommendation of Lovenox, to prevent blood clots, the majority of patient's (70 to 90%) did not receive adequate levels of Lovenox at times throughout the day, which likely increases the risk of developing clots. The increase in blood volume and increase in kidney function that occurs in pregnancy may contribute to the inadequate levels. Currently the recommendation for pregnant and nonpregnant patients requiring Lovenox, is to calculate the daily dose of Lovenox and split the dose, giving half in the morning and the other half in the evening. This research study proposes that due to changes in the body during pregnancy that the daily Lovenox dosing be split into three times a day to achieve more consistent levels of Lovenox than twice a day in pregnant women.

RECRUITING
Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery
Description

One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide. A preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes.

COMPLETED
Time-in-range Using Continuous Glucose Monitoring Management of Gestational Diabetes Mellitus
Description

The continual glucose is going to increase time-in-range compared to the standard method in women with gestational diabetes

TERMINATED
Ideal Time of Oxytocin Infusion During Cesarean Section
Description

This study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss. Half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta. We hypothesize that administering oxytocin after delivery of the shoulder, will result in less overall maternal blood loss.

COMPLETED
The Snack Study: The Feasibility of Changing Night-time Food Choices to Improve Glucose Tolerance in Pregnancy
Description

Obesity during pregnancy increases the risk for high glucose and diabetes in the mother, and for obesity and comorbid metabolic disease in the offspring. Results of previous intervention studies designed to improve the metabolic health of obese mothers, and thereby reduce the risk to their offspring, have been modest at best. Furthermore, few studies have proved to be efficacious among low income African American women who have high risk for the transmission of obesity to future generations. The purpose of this study is to examine the feasibility of changing the types of foods and drinks that are consumed at night during late pregnancy in order to improve maternal glucose tolerance and reduce the risk for future obesity in the child.

COMPLETED
Peri-operative Cefazolin Prophylaxis at Time of Cesarean Delivery in the Obese Gravida
Description

Obesity has become an increasingly prevalent public health problem in the United States, reaching epidemic proportions. According to 2009 CDC epidemiologic data on obesity in the United States, 35.7% of the United States population is considered overweight or obese. Currently, on the review of the literature, over 20% of pregnancies in this country are complicated by maternal obesity. Obesity has been well demonstrated to be correlated with numerous adverse pregnancy outcomes such hypertensive disorders of pregnancy, gestational diabetes, and increased rates of operative delivery. Moreover, obesity, irrespective of pregnancy, has been demonstrated to be an independent risk factor for the development of postoperative surgical site infections. Development of such infections can have both consequential long-term medical sequelae for patients and economic impacts on the health care system at large. Cefazolin, a first generation hydrophilic cephalosporin whose clearance is exclusively mediated via the kidneys unchanged, is used as pre-operative antibiotic prophylaxis for cesarean deliveries. The current accepted standard of care is to administer 2 grams of cefazolin within 60 minutes of skin incision. Studies of drug concentrations of cephalosporins for pre-operative antibiotic prophylaxis in obese bariatric patients have shown that therapeutic concentrations may not be achieved in both tissue and plasma. Limited data exist in pregnancy. Therefore, it is the goal of this study to investigate whether obese patients presenting for cesarean delivery require an increased dosing amount of pre-operative antibiotic prophylaxis. This study will randomized women with a pre-pregnancy body mass index of 30 kg/m2 or more who are presenting for their scheduled cesarean delivery to receive either 2 grams or 3 grams of cefazolin for pre-operative antibiotic prophylaxis. By drawing blood at specific time points in the peri-operative period and extracting adipose tissue samples during cesarean delivery, this study will investigate the pharmacokinetics of cefazolin in both the plasma and tissues of the obese gravida.

UNKNOWN
US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
Description

The purpose of this clinical investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates.

Conditions
COMPLETED
Time to Conceive: A Study of Fertility
Description

The purpose of this research study is to learn a way to measure a person's fertility. After 1 year of trying, 1 out of every 7 women will not be pregnant. This is called infertility. This results in significant distress and anxiety. Infertility is common; however, the investigators have no markers to predict who will be infertile. For couples diagnosed with infertility, the investigators have used blood and urine hormone levels (follicle stimulating hormone (FSH), inhibin B, and antimullerian hormone (AMH)) to tell us who will get pregnant with fertility treatment. The investigators don't know if these hormone levels can predict if regular people trying to get pregnant will be able to get pregnant. This study will try to determine if these hormone levels can predict fertility and infertility.

Conditions
COMPLETED
Behavioral and Environmetal Factors and Time to Delivery
Description

This study, conducted at the Naval Medical Center in San Diego, CA, will determine if having vaginal intercourse in the last weeks of pregnancy decreases the risk of having a prolonged pregnancy. Pregnancies that continue beyond the due date may increase health risks for the mother and the baby. Although some believe that vaginal intercourse can help start labor in the last weeks of pregnancy, there is not proof that it works. Some studies showed that sexual intercourse helped and some that pregnancy lasted even longer for couples having sex. In addition to exploring the effect of sexual intercourse on time to delivery, this study will collect information that can be used in the future to predict when labor will naturally start and the risk for overdue pregnancies. Women 18 years of age and older in their first pregnancy who are carrying a single fetus with gestational age before 38 plus 6 weeks may be eligible for this study. Candidates must be living with their partner in a stable relationship. Participants are asked to have sexual intercourse about three times per week. They complete a diary in which they record the times they have intercourse and how they are feeling daily. The diaries are submitted by mail each week or at the doctor's or midwife's visit until delivery. The women have a pelvic exam and ultrasound and complete questionnaires about problems during pregnancy, overall well-being, attitude toward induction of labor, physical activity, body image during pregnancy, stress and social support, habits at home, and environmental conditions, such as weather.

Conditions
ACTIVE_NOT_RECRUITING
Calcium Carbonate on Labor Induction
Description

The investigators aim to evaluate the safety and efficacy of administering calcium carbonate to laboring participants undergoing labor inductions. The investigators hypothesize that calcium carbonate is a low-risk preventative measure to decrease oxytocin induction time and dosage, decrease the rate of labor dystocia, decrease the rate of cesarean deliveries, and demonstrate no differences in maternal or neonatal safety outcomes.

RECRUITING
Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
Description

A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.

UNKNOWN
Preconception Reproductive Knowledge Promotion (PREKNOP)
Description

This study examines the efficacy of the "Preconception Reproductive Knowledge Promotion (PREKNOP)" intervention, designed to promote women's reproductive health and positive pregnancy outcomes. The study's goal is to educate low-income women about reproductive changes related to their menstrual cycle. The main hypothesis of the study is that women who receive the PREKNOP intervention will report reduced risk of unplanned pregnancy and increased reproductive knowledge, self-efficacy about that knowledge, and pregnancy planning ability.

Conditions