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Pregnancy Complications clinical trials

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NCT ID: NCT04014452 Active, not recruiting - Microwave Ablation Clinical Trials

Microwave Ablation vs Radiofrequency Ablation in the Management of Complicated Monochorionic Pregnancies:A RCT Study

MWAvsRFA
Start date: July 15, 2019
Phase: N/A
Study type: Interventional

Complicated pregnancies refer some special complications, including twin to twin transfusion syndrome(TTTS), twin reverse arterial perfusion(TRAP), selective intrauterine fetal growth restriction(sIUGR), twin anemia-polycythemia sequence(TAPS), one fetal death or structural abnormalities, etc. Complicated twins are often associated with high perinatal morbidity and mortality. Severe complicated twins can be treated with fetal-reduction surgery during pregnancy, which can improve the survival rate of retained fetuses and reduce the disability rate. The managements include mechanical umbilical cord ligation or thermal coagulation obliteration, such as bipolar coagulation (BCC), radiofrequency ablation (RFA), and laser coagulation.Nowadays radiofrequency ablation reduction is the most common, which processes a higher survival rate and fewer maternal and fetal complications compared with other ways.Latest experience suggests that microwave ablation(MWA) is also easy to be used and the therapeutic effect is similar with RFA, but there is no convincing evidence. Compared with radiofrequency ablation, MWA has the advantages of simple operation and time, and avoids the problems of tissue carbonization, drying and heat sink effect. For fetation reduction surgery, the main advantage is that the endothermic effect near the blood vessels is smaller, which enables microwave fetation reduction to have a larger ablation range and a higher thermal effect. This study is comparing Microwave Ablation(MWA) and radiofrequency ablation (RFA) methods for selective fetal reduction in the treatment of complicated monochorionic (MC) multifetal gestations. This is a pilot randomised controlled trial(RCT) of 60 patients who undergo selective fetal reduction. The subjects of this study were all pregnant women and their offspring who underwent reduction surgery in the third hospital of Beijing University, and patients are randomly assigned 1:1 to different intervention groups by parallel design. The outcome evaluators were blind. Collecting their surgery, clinical information and maternal and fetal complications at a week and a month after surgery, 42 days and 6 months after delivery, to verify the safety and efficacy of MWA, and find a better treatment plan for complicated monochorionic pregnancies .The primary outcome was neonatal survival rate.

NCT ID: NCT03904979 Active, not recruiting - Clinical trials for Pregnancy Complications

Therapeutic Writing to Reduce Stress

RESeT
Start date: October 22, 2019
Phase: N/A
Study type: Interventional

Purpose: The investigators hypothesize that exposure to chronic environmental stress is a risk factor for adverse pregnancy outcomes related to preterm birth and preeclampsia among high-risk pregnant women. Additionally, the investigators hypothesize that women can be screened for high levels of environmental stress through the perceived stress scale, and therapeutic writing can be used as a low-resource intervention to help decrease maternal perceived stress and inflammation - measured through analysis of maternal serum and placental samples. Participants: Pregnant women at high risk for adverse pregnancy outcomes, including pre-eclampsia and preterm birth, enrolled in prenatal care at UNC will be recruited for participation Procedures: Using results from the perceived stress scale, the investigators will identify women who screen positive for high environmental stress. Women meeting inclusion criteria will be contacted for possible participation at regularly scheduled prenatal visits. Women who are enrolled will be randomized to generalized writing prompts, therapeutic writing prompts, or no writing during their pregnancy to be administered at each prenatal visit. 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. Delivery outcomes will be obtained through medical record review.

NCT ID: NCT03826342 Active, not recruiting - Drug Use Clinical Trials

Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy

Start date: April 16, 2019
Phase: N/A
Study type: Interventional

This proposed study is to test whether Health Check-up for Expectant Moms (HCEM), a computer-delivered screening and brief intervention (SBI) that simultaneously targets sexually transmitted infection (STI) risk and alcohol/drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care.

NCT ID: NCT03523143 Active, not recruiting - Clinical trials for Pregnancy Complications

The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes

TESGO
Start date: June 11, 2018
Phase: N/A
Study type: Interventional

Context: Women with gestational diabetes have excessive fetus growth weeks earlier than the screening period recommended currently, suggesting that earlier screening and intervention may improve pregnancy outcomes and the health of the offspring. Objective: To determine if early screening and intervention could alter pregnancy outcomes, the incidence of maternal diabetes after delivery, and growth and development of the offspring, compared to the standard group. Design, Setting, Participants: We will conduct a multi-center open-label randomized controlled trial in 2068 pregnant women, who deliver a singleton and who have not been diagnosed with overt diabetes mellitus at National Taiwan University Hospital (NTUH) and NTUH Hsinchu Branch from 2018 to 2020. Interventions: Gestational diabetes mellitus (GDM) is diagnosed by a 75g 2-hour OGTT at 18-20 weeks of GA for the early-screening group and at 24-28 weeks for the standard-screening group. The diagnostic cutoffs are according to the IADPSG criteria. GDM is diagnosed if one of the plasma glucose levels at fasting, 1-hour, and 2-hour during OGTT is above 92 mg/dL, 180 mg/dL, or 153 mg/dL respectively. Subjects who are diagnosed with GDM receive lifestyle intervention and self-monitoring of blood glucose. Pharmacological therapies are given when the target of glycemic control is not achieved within 4-6 weeks. Main Outcome Measure: The primary outcome is a composite measure of pregnancy outcomes, including primary CS, birth weight >90th percentile, neonatal hypoglycemia, cord serum C-peptide >90th percentile, pregnancy-induced hypertension, preeclampsia, and birth trauma. The primary outcome is measured within the entire period of perinatal and neonatal intensive-care units (NICU) stay for infants and the entire period of gestation for pregnant women after randomization. Conclusion: This study will test our hypothesis that early screening and intervention of GDM improves pregnancy outcomes as compared to standard practice.

NCT ID: NCT03249896 Active, not recruiting - Clinical trials for Gestational Diabetes

Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes

SMART-GDM
Start date: September 5, 2017
Phase: N/A
Study type: Interventional

Gestational diabetes mellitus (GDM) affects one fifth of Singaporean pregnancies and can result in short and long term complications for mother and child. Mobile applications are effective in improving diabetes care and weight related behaviors through improved self-management. A multidisciplinary healthcare team from National University Hospital, Singapore has worked with Jana Care to develop the Habits-GDM smartphone app, a lifestyle coaching program specific for gestational diabetes. It consists of interactive lessons to provide patient education, diet, activity and weight tracking tools, messaging platform for coaching and motivating patients towards healthy behavior beneficial for gestational diabetes. It interfaces with the Aina device, a novel hardware sensor that plugs into any smartphone and can be used for glucose monitoring. This study aims to test the effectiveness of this app in preventing excessive weight gain in pregnancy among patients with gestational diabetes.

NCT ID: NCT03099837 Active, not recruiting - Clinical trials for Pregnancy Complications

Tongji Maternal and Child Health Cohort

TMCHC
Start date: January 10, 2013
Phase:
Study type: Observational

This is a population-based study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by IOM (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring.

NCT ID: NCT02766426 Active, not recruiting - Exercise Addiction Clinical Trials

Cytokine and Body Composition's Changes in Overweight/Obese Women

Start date: January 2015
Phase: N/A
Study type: Interventional

Sincev the adipose tissue as been identified as a metabolic active tissue that produces and regulates pro-inflammatory factors, the investigators studied the relationship between cytokine changes and maternal body composition. The investigators evaluated plasmatic pro- and anti-inflammatory cytokines levels in pregnant women with BMI >25 Kg/m^2 undergoing a lifestyle change program, and if this is related with changes in body composition. Women enrolled in the study were provided nutritional advices about lifestyle: a proper nutrition and a constant physical activity (30 minutes/day, 3 times/week, according to the American College of Obstetricians and Gynecologists Guidelines) in an integrated counselling with a dietitian and a gynaecologist, both attendant since the enrollment. Plasma pro- and anti-inflammatory markers were investigated at enrollment (9-12 weeks) and at 36-38 weeks. Furthermore, the investigators used the bioimpedance analyzer to evaluate changes of body composition (i.e. fat mass and fat free mass) at first and third trimester.

NCT ID: NCT02298569 Active, not recruiting - Clinical trials for Pregnancy Complications Nos

Early Postnatal Discharge in a French Perinatal Network

SORPRISE
Start date: September 2014
Phase: N/A
Study type: Interventional

The purpose of this "before-after" study is to determine the effectiveness of a multidimensional intervention to increase the rate for early discharge of low-risk mothers and the healthy newborn in a perinatal network.

NCT ID: NCT00946088 Active, not recruiting - Clinical trials for Pregnancy Complications

Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial

Start date: October 2009
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT00573118 Active, not recruiting - Preeclampsia Clinical Trials

Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity

Start date: January 2000
Phase: N/A
Study type: Observational

Congenital and acquired thrombophilia were identified as risk factors for thrombosis in systemic vessels.Thrombophilias have also been recently found to be associated with preeclampsia, intrauterine fetal growth restriction (IUGR), placental abruption, intrauterine fetal death (IUFD) and repeated pregnancy loss.These severe pregnancy complications are thought to result from thrombotic events occurring in the uteroplacental circulation. Accumulating data have established an association between elevated plasma activity of factor VIII and thrombosis although the mechanism is still not defined and elevated factor VIII activity is now regarded as being equivalent to thrombophilia. We intend to investigatthe association between factor VIII levels and severe pregnancy complications which are considered to result from placental vascular pathology, i.e., preeclampsia, IUGR, placental abruption and IUFD. We hypothezise that the prevalence of elevated factor 8 will be higher among women with pregnancy complications compared to controls.