Active clinical trials for "Pregnancy Complications"

Women living in low-income countries are at elevated risk of death in connection to pregnancy, as well as infants born to women in such settings. It is probable that several factors are involved, such as poverty, lack of education and access to healthcare. Infectious diseases constitute important threats to maternal health in resource-limited settings. Tuberculosis (TB) is reported to be the third leading cause of maternal death globally. Furthermore, TB can be transmitted from mother to child during pregnancy, with high risk of severe consequences for the infant. Despite these data, neither the role of TB in relation to co-existing risk factors for adverse pregnancy outcomes, nor the mechanisms involved, are well understood. It is likely that TB interacts with other characteristics, in particular socio-economic condition and HIV infection, which could obscure associations between TB and pregnancy outcomes. For this reason, it is critical to design studies so that the independent role of TB can be deduced. This project aims to investigate how TB infection in women affects the risk of adverse pregnancy outcomes in relation to co-existing factors, and how exposure to TB infection may impact growth and development of infants born to women with TB. In addition, mechanisms in which TB and the immune system during pregnancy will be explored. The project is conducted at public health facilities in Ethiopia, where 2 000 women have been recruited during antenatal care. These women will be followed until 5 years after delivery, along with their offspring born during the study period. Detailed data is collected at inclusion and at study visits during follow-up, with submission of samples for TB testing and immunological analyses. Better knowledge on the characteristics of TB infection in association with pregnancy, and how TB affects maternal and child health, can be used to construct new guidelines for management of TB in women of fertile age. This may contribute to reductions in adverse pregnancy outcomes, including maternal and infant deaths.

TRACES trial is a multicenter randomized double blind placebo control therapeutic and pharmaco-biological dose ranging study to measure the effect on blood loss reduction of a single intravenous infusion of two doses regimens (standard dose and low dose) of TA administered at the onset of an active PPH (>800mL) during elective or non-emergent CS and to correlate this clinical effect with the biological effect of fibrinolysis inhibition and the pharmacodynamic measure of TA uterine bleeding and venous blood concentration.

Purpose: The objective of this proposal is to study the safety and efficacy of metformin added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women. Participants: 950 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S. clinical centers Procedures (methods): Pregnant women with T2DM between 10 weeks and 22 weeks 6 days and a singleton fetus will be randomized to double-blinded insulin/placebo versus insulin/metformin. Primary outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical visits; blood draw at 24-30 weeks, newborn anthropometric measurements at less than 72 hours of life. Maternal and infant outcomes will be chart abstracted.

Preterm delivery is the most common cause of infant morbidity and mortality in the United States. Some women have episodes of preterm labor during their pregnancy which can be temporarily stopped. These women, however, are at high risk for delivering before term. At this time, we do not have sufficient evidence to use any medication to help prevent these women from delivering early. Recently, preliminary studies have shown that progesterone may help prevent some women at high risk for preterm delivery from delivering early. Our study will investigate whether progesterone can help this specific group of women, women with arrested preterm labor, deliver healthy infants at term.

This is a two-part randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA). Part 1 is an open-label study to evaluate safety and tolerability of two doses of volixibat. Part 2 is a double-blind, placebo controlled, study designed to evaluate the safety and efficacy of a selected volixibat dose.

Mental illness increases the risk of adverse birth outcomes (e.g. preterm birth), obstetric complications (e.g. emergency caesarean, birth injuries), and birth trauma. Sexual and gender minority (SGM) people on average experience increased mental illness. Therefore these risks are increased, with risk of prolonged ill health. Despite this, research in this area is scanty. The present project will provide important knowledge for improving the reproductive health of SGM people. The overall purpose of the project is to increase knowledge about physical and mental health (including fear of childbirth) during pregnancy and postpartum in SGM people. The project has the following aims: PART I 2017 - 2021Pilotstudy To study fear of childbirth (FOC) among SGM people in Sweden; prevalence and factors associated to FOC To investigate reasons to and consequences of FOC in SGM people PART II 2022-2027 Main study To explore whether SGM people in Sweden have an increased incidence of mental illness during and after pregnancy, adverse birth outcomes, obstetric complications and birth trauma. To explore how pre- and postnatal mental health, minority stress, and fear of childbirth correlate to birth outcomes, birth experience, and obstetric complications in SGM people. This is important for identifying specific risk factors for difficult births, and to explore postpartum health effects. To explore in-depth how SGM people have experienced adverse birth outcomes, obstetric complications, and birth trauma, with a specific focus on minority stress and experiences of care during and after pregnancy and childbirth.

Nutritional status during pregnancy plays an important role in maternal health and birth outcomes. While few factors impacting nutritional status during pregnancy have been identified, studies of undernutrition in children have revealed a key role for the gut microbiome. Remarkably, studies examining the dynamics of the maternal gut microbiome before and during pregnancy and its impact on birth outcomes are limited. This study is being conducted to investigate how a mother's nutritional status and her gut microbiome during pregnancy contribute to the birth outcomes and health of her baby. The gut microbiome is the totality of microorganisms (e.g. bacteria, viruses, fungi) living in the gastrointestinal tract. This study will focus on married pregnant women 24 years and younger living in Matiari District in Pakistan. The focus is on younger women due to their vulnerability to undernutrition. Pregnant participants, and upon delivery, their newborns will be followed throughout pregnancy and for a year afterwards. Throughout this period, the investigators will collect stool samples, rectal swabs, blood samples, health assessments, nutritional and dietary assessments and birth/ labour details. The goal is to define the relationship between a mother's nutritional status and her microbiome dynamics during pregnancy and how they contribute to the birth outcomes and growth of her newborn. Investigators hypothesizes that alterations of the microbiota in the maternal gut (dysbiosis) is exacerbated by nutritional status or pathogen exposure during pregnancy. This impacts weight gain because of impaired nutrient absorption, and can lead to corresponding negative birth outcomes.

A course of steroids given to a mother who is in labor with a premature fetus will reduce the risk of the premature infant dying or having serious complications. This trial will test whether more than one course of antenatal steroids is more beneficial or risky to the infant than a single course.

Approximately 1 in 500 pregnant women require non-obstetric surgery. Surgical care for the pregnant woman raises concern for complications adversely affecting pregnancy outcomes. The most common reason for surgery is acute appendicitis followed by gallbladder disease. Despite the common incidence of non-obstetric surgery among pregnant women, little is known regarding fetal outcome and the impact of laparoscopic interventions versus traditional open procedures. Even less is known about the role of non-operative management of general surgical disease in the pregnant population. However, fetal outcome is not compromised by emergency general surgery condition interventions.

Purpose: The investigators hypothesize that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women reduce their stress during pregnancy. Participants: Pregnant women enrolled in prenatal care at the University of North Carolina who have a documented moderate or high level of perceived stress ( ≥ 14) and are at high risk for adverse pregnancy outcomes due to body mass index of ≥ 30 kg/m2 or history of gestational hypertension, preeclampsia, intrauterine growth restriction, or preterm birth <37 weeks' in a prior pregnancy. Procedures: Women meeting inclusion criteria will be recruited through the University of North Carolina prenatal care clinics. They will be contacted for possible participation at regularly scheduled prenatal visits and/or ultrasound. They may also be contacted for possible participation by remote methods (e.g., Telehealth). Women who are enrolled will complete validated dietary, stress, sleep, and body image questionnaires. Enrolled women will then be randomized to receive standard obstetrical care or enhanced counseling. All participants will receive a wrist-based activity tracker. Maternal blood sample for biochemical markers of stress and gene expression will be obtained at the initial visit; a followup blood sample will be obtained later in pregnancy, and a small portion of the placenta saved at delivery. Maternal and neonatal outcomes will be compared between groups.