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Pregnancy Complications clinical trials

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NCT ID: NCT05551078 Recruiting - Clinical trials for Pregnancy Complications

Thrombophilia Screening After Severe IUGR

Start date: September 15, 2022
Phase:
Study type: Observational

This retrospective study aims to assess the input of thrombophilia screening in pregnant women with severe intra-uterine growth restricted babies.

NCT ID: NCT05543499 Recruiting - Clinical trials for Twin to Twin Transfusion Syndrome

Database of Monochorionic Pregnancies

Start date: October 1, 2022
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to collect and analyze data regarding natural history, indications for fetal interventions, and maternal and fetal/neonatal outcomes associated with complicated monochorionic twin pregnancy.

NCT ID: NCT05537480 Recruiting - Diabetes Mellitus Clinical Trials

Correlation of CGM Metrics With OGTT and Pregnancy Outcomes in Pregnant Women With or Without a High Risk for GDM

Start date: January 14, 2022
Phase: N/A
Study type: Interventional

the aim of the study is to obtain CGM data concomitant with OGTT and to determine what CGM metrics obtained in pregnant women with and without a high risk of GDM correlate best with the diagnostic OGTT (obtained via the 2-step and 1-step approaches).

NCT ID: NCT05534568 Recruiting - Pregnancy Related Clinical Trials

The Oklahoma Parent-Child Assistance Program

Start date: November 15, 2022
Phase: N/A
Study type: Interventional

The Parent-Child Assistance Program (PCAP) helps mothers who have used alcohol, opioids, or other drugs during pregnancy and their children through the work of highly trained, closely supervised case managers. Case managers work closely with mothers over the course of three years, meeting the mothers in their own homes when possible, to help them to set goals and take advantage of available resources. The primary aims of PCAP include: (1) assisting mothers in obtaining substance use disorder (SUD) treatment and staying in recovery, (2) linking mothers to community resources that will help them build and maintain healthy, independent family lives for themselves and their children, and (3) preventing future drug and alcohol use during pregnancy. This study brings PCAP to Oklahoma (the state with the highest incarceration rate for women, where most enter the criminal justice system for drug charges) for the first time. This five-year project includes 200 women who will enroll in the study and be randomly assigned to the treatment (100 women) or control group (100 women). The intervention (i.e., PCAP services) will take place over a three-year period at two sites: Oklahoma City, Oklahoma and Tulsa, Oklahoma. This evaluation will measure participants' substance use, substance use disorder (SUD) treatment outcomes, and a host of other well-being outcomes-including but not limited to subsequent substance-exposed births, use of public assistance, education, use of family planning methods, and employment-to evaluate the effects of PCAP services. Among these, the investigators have identified four key outcomes: (1) the mother is on a reliable method of birth control, (2) abstinence for six months, (3) child custody (i.e., placement of children in foster care and/or with kinship providers), and (4) criminal justice involvement.

NCT ID: NCT05527327 Completed - Obesity Clinical Trials

Pannus Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot Study

Start date: September 16, 2022
Phase: N/A
Study type: Interventional

Pregnancies complicated by obesity have an increased risk of multiple pregnancy complications, including structural fetal anomalies. Therefore, maternal obesity (BMI ≥30 kg/m2) is an indication for a detailed anatomic ultrasound examination. Ultrasound is a critical tool for the detection of congenital anomalies; however, obesity makes ultrasound examinations technically challenging. The primary objective of this ambidirectional cohort pilot study is to evaluate whether utilization of a pannus retractor is associated with increased rates of detailed anatomic ultrasound completion amongst pregnant patients with a body mass index (BMI) greater than or equal to 40 kg/m2. Retrospective data will be collected for 100 patients with a BMI of 40 kg/m2 or greater to assess the baseline rate of completion of 16 components of the detailed anatomic survey prior to the intervention. We plan to enroll 20 patients into a prospective pilot to the intervention arm. The intervention is placement of an adhesive medical device, the traxi® Panniculus Retractor (Laborie, Portsmouth, New Hampshire), which was developed for pannus retraction during cesarean section. Adequacy of anatomic ultrasound completion will be based upon 16 pre-defined views from the anatomic survey. Ultrasound completion rates from the prospective cohort of participants that undergo ultrasound evaluation using a pannus retractor will be compared to a historical cohort without pannus retractor use. We hypothesize that use of a pannus retractor for pregnant participants with BMI greater than or equal to 40 kg/m2 increases the rate of anatomical ultrasound completion.

NCT ID: NCT05524259 Recruiting - Clinical trials for Polycystic Ovary Syndrome

MYPP-trial: Myo-inositol Supplementation to Prevent Pregnancy Complications in Women With Polycystic Ovary Syndrome.

MYPP
Start date: June 21, 2019
Phase: N/A
Study type: Interventional

Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS is a heterogeneous condition, characterised by metabolic disturbances, insulin resistance and hyperandrogenism. Pregnancies in women with PCOS have an increased risk of gestational diabetes mellitus, preeclampsia and preterm birth, and their offspring have an increased risk of aberrant birth weight and hospitalization. After pregnancy, PCOS is thought to have an impact on breastfeeding success and breastmilk composition. Current strategies to improve pregnancy outcome among women with PCOS have not demonstrated significant risk reduction. Myo-inositol is a commonly used dietary supplement with a favourable effect on glucose metabolism and insulin sensitivity. Optimal intake of myo-inositol is associated with a decrease in glucose, lower insulin and lower testosterone levels in women with PCOS. Among women with PCOS-related disorders (e.g. in women with obesity), myo-inositol supplementation in pregnancy has been shown to have clinical benefits in preventing adverse pregnancy outcomes in a number of clinical trials, by reducing the risk of gestational diabetes mellitus, hypertensive complications and preterm birth. The MYPP-trial will be the first randomised prospective trial aimed specifically at pregnant women with PCOS, to evaluate the potential effectiveness of myo-inositol supplementation as a nutritional intervention to prevent all three pregnancy complications associated with PCOS (i.e. GDM, preeclampsia and preterm birth). Secondary objectives are to evaluate the impact of supplementation on maternal (mental) and neonatal health, breastfeeding practices and breastmilk composition. In addition, a full cost-effectiveness analysis will be performed. Women with a diagnosis of PCOS and a singleton pregnancy between 8+0 and 16+0 weeks of gestational age are eligible. Participants randomly allocated to the intervention group will receive 4 grams myo-inositol added to their routinely recommended folic acid supplement, divided over two daily sachets of sugary powder throughout pregnancy. The control group will receive similar looking sachets of supplements containing only the standard dose of folic acid without the added myo-inositol supplement, as part of the current standard-of-care recommendation. In addition to receiving supplements, participants will be asked to complete three questionnaires, provide blood and urine samples once each trimester of pregnancy, and routine ultrasound scanning will be performed to assess fetal growth. All study visits will be aligned with routine antenatal care appointments. Additionally, subjects can choose to participate in research on the impact of myo-inositol supplementation on breastfeeding and take part in the MYPP biobank. The results of this study will provide important novel recommendations for PCOS patients on the importance of optimising life-style and nutrient intake to improve pregnancy outcome.

NCT ID: NCT05503849 Not yet recruiting - Child Development Clinical Trials

Born In Guangzhou Intervention Study

BIGIS
Start date: March 2024
Phase: N/A
Study type: Interventional

The main objective of this study is to test the efficacy of an intervention package (dietary, physical and lifestyle modification) during pregnancy in improving the clinical outcomes of mother-infant dyads.

NCT ID: NCT05492708 Recruiting - Pregnancy Related Clinical Trials

The Heartland Study

Start date: January 11, 2020
Phase:
Study type: Observational

The Heartland Study is a prospective, observational study that will enroll up to 2,600 pregnant participants across the Heartland States in the U.S.. The objective of the Heartland Study is to address major knowledge gaps concerning the health effects of herbicides on maternal and infant health. The study is being conducted to evaluate the associations between environmental exposures to herbicides during and after pregnancy and reproductive health outcomes. The study is measuring multiple biomarkers of herbicide exposure among pregnant Midwesterners and their partners to evaluate associations with pregnancy and childbirth outcomes, epigenetic biomarkers of exposure, and child development.

NCT ID: NCT05475951 Completed - Clinical trials for Pregnancy Complications

Gasdermin-D and Pannexin-1 in Pregnancy

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

One -third of fertile women around the world are overweight or obese. This means increasing risk for both the mother and the child. Fat tissue is a factor in gestational DM development and the increase in material inflammation and oxidative stress. According to new knowledge, it is an important need to examine molecules that are not handled in new and human research in these mechanisms in fat and placenta tissues in obesity. For this purpose, the examination of the expression of gasdermin-D and pannex-1 proteins, which are shown to be produced in the cells of both tissues, is worth investigating in human fat tissue and placenta. Gasdermins and pannexins are proteins intersecting by interacting in cellular functions. Gasdermins cause piroptosis, a type of litic proinflammatory cell death. Pannexin-1 plays in various cellular functions, including inflammation. These are examined in a small number of in vitro studies in material fat tissue and placenta, and the design of this study in people whose applications are applied is original in humans. The status of the expressions of the gasdermin-D and pannexin-1 proteins, which will be examined for the first time in obese pregnant women's fat and placental tissues, are the subject of this research with each other and their relationship with other maternal and neonatal data.

NCT ID: NCT05465304 Completed - Clinical trials for Pregnant With Complication

Effect of Azithromycin in Preventing Premature Labour

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

This is a prospective observational case controlled study. The control group will include pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy. The test group will involve pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin