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167 active trials for Pregnancy

Evaluation of Respecting the Circle of Life on Pregnancy Prevention Outcomes Among American Indian Adolescents

The objective of this research study is to evaluate a culturally tailored sexual and reproductive health intervention among American Indian (AI) youth. Specifically, the investigators aim to evaluate the impact of "Respecting the Circle of Life: Mind, Body and Spirit" on knowledge, attitude and behavioral outcomes associated with risk for unprotected sex, sexually transmitted infection (STI) and unintended pregnancy through a randomized controlled trial on the White Mountain Apache (WMA) reservation. The investigators will examine whether the RCL intervention effectively reduces risky sexual behavior among AI adolescents (11-19 years old), with long term goals of reducing teen pregnancy and incidence/prevalence of STIs. The evaluation will focus on well-established intermediate outcomes/risky sexual behaviors that predict long-term impact on teen pregnancy and STI incidence.

Start: May 2016

The Cymbalta Pregnancy Registry

The Cymbalta Pregnancy Registry is a U.S. based Registry designed to monitor women who are exposed to Cymbalta (duloxetine) during pregnancy. This is an observational, exposure-registration and follow-up registry.

Start: July 2009

Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine

This pilot study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.

Start: March 2016

Evaluation of Drug's Risk in Pregnant Women

Medication during pregnancy can lead to the occurrence of birth defects or neonatal pathologies. Thalidomide or diethylstilbestrol (Distilbene°) are prominent examples. Many drugs remain insufficiently evaluated in this area and doctors are too often deprived of relevant information when prescribing drugs in pregnant women.

Start: January 2010

Advanced Fetal Imaging - Phase II

The goal of Advanced Fetal Imaging - Phase II is to advance fetal MRI imaging by designing MRI coils specifically for pregnant women and testing recently developed MRI image acquisition techniques. The investigators aim to more reliably obtain higher quality fetal MRI images when compared to current clinical fetal MRI.

Start: July 2016

Efficacy and Safety of Medication Used to Stimulate Ovulation

Individuals undergoing In Vitro Fertilization must undergo controlled ovarian hyperstimulation (COH) to produce enough quality eggs for fertility treatment. Ovarian follicular responsiveness to COH with gonadotropins is extremely variable between patients and even from cycle to cycle for the same patient. Achieving an ideal follicular response is critical to the success of assisted reproduction treatment (ART). Patients have been classified as 'poor', 'normal' or 'high' responders, which dictate the amount of gonadotropins that they receive. It is still important to develop treatments with high efficacy, lower multiple birth rates, and a lower complication rate for each of these groups. In an era of evidence-based medicine and with special emphasis on reducing IVF risks (mainly OHSS and pregnancies with multiples), it is very important to find optimal and safe ovulation induction and triggering regimens for each patient population. The use of GnRH agonist (GnRHa) triggering among high responders in order to reduce or eliminate OHSS is an example of an important breakthrough in the clinical management of IVF patients. Although GnRHa triggering was shown to be as effective as human chorionic gonadotropin (hCG) at inducing oocyte maturation more than 20 years ago, its use to trigger ovulation was not possible until the introduction of GnRH antagonists for pituitary suppression. Another prominent trend in ART in recent years has been the introduction of dual triggering, which involves a combination of GnRHa plus hCG for triggering. This regimen creates simultaneous lutenizing hormone (LH) and follicle stimulating hormone (FSH) surges by the GnRHa, which resembles physiologic ovulation triggering, together with sustained LH-like activity from the hCG, which stimulates the corpus luteum to excrete sufficient hormonal endometrial support. Since its introduction, dual triggering has been gaining popularity due to outstanding results in retrospective studies among both normal and high responders. Moreover, in spite of the encouraging retrospective reports, prospective randomized controlled trials (RCT) on dual triggering have not been reported to date. The aim of the current proposed study is to compare the efficacy of dual triggering and conventional triggering among the three IVF populations (high, normal and poor responders).

Start: October 2015

Happy Mommy! Happy Baby! Study

The purpose of this study is to determine how difficult life-events that women experienced during their childhood might affect their babies. Women who are asked to participate in this study will fill out forms about their physical and mental health, have 3D ultrasounds of their baby's adrenal gland, have their stress responses measured and have their baby's development and stress responses assessed.

Start: August 2012

Placental Passage and Disposition of Drugs: A Physiology-based Approach

The investigators aim to integrate the outcomes in physiology-based pharmacokinetic (PBPK) models to put the generated data into context with medical conditions that require maternal or fetal drug therapy (e.g. HIV). These models will be validated with available 'real-life' maternal and fetal PK data, such as data from the PANNA network. Ultimately, these PBPK models of drug therapy during pregnancy will provide a powerful tool to 1.) assist in designing rational dosing adjustments, 2.) prevent intervention-based research in pregnant women in the future, and 3.) guide future development of new molecular entities (e.g. preventing heavy investment in drugs with high predicted fetal exposure and potentially toxic effects in utero).

Start: February 2015

TEGSEDI Pregnancy Surveillance Program

This is a worldwide safety surveillance study of pregnancy outcomes in women with hATTR-PN who may have been exposed or were not exposed to TEGSEDI prior to or during the pregnancy and of pediatric outcomes up to 1 year of age.

Start: December 2020

Healthy Start: Exploring the Fuel-mediated Programming of Neonatal Growth

The purpose of this study is to establish and follow longitudinally a cohort of ethnically diverse pregnant women and their offspring, in order to explore the hypothesis that fetal over-nutrition is associated with obesity, metabolic, and cardiovascular abnormalities in the offspring.

Start: July 2009

Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery

The purpose of this study is to assess the efficacy of an electronic-based intervention to help pregnant overweight and obese women gain an appropriate amount of weight and improve their delivery i.e. to reduce the rate of labour procedures and interventions. We chose a composite outcome including instrumental delivery and Caesarean section, as clinically relevant outcomes because the mode of delivery is one of the major goals of the obstetrical management and is is strongly associated with body mass index and gestational weight gain.

Start: November 2017

Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal Movement and Uterine Activity Detection

Owlet Baby Care, Inc. has developed a wearable fabric band pregnancy monitor, to be worn around the maternal abdomen incorporating electrocardiogram sensors. The purpose of this proposed test is to collect overnight "at-home" fetal ECG recordings on women during the second half of pregnancy using the pregnancy monitor.

Start: August 2018

Chinese Pregnant Woman Cohort Study (Offspring Follow-up)

Purpose: To investigate the growth and development status for children of 1 ~ 3 years old in China, and to explore and analyze the influencing factors of infant growth. Mother's health status would also be investigated simultaneously. Methods and analysis: This is a multicenter prospective cohort study. Participants were all from the Chinese Pregnant Women Cohort Study (CPWCS), which is a multicenter prospective cohort study we conducted before. In simple terms, pregnant women during the first trimester (5~13 weeks' gestational age) were included from 25 July 2017 to 26 November 2018. Related information were collected by electronic self-administered questionnaire, including general information, environmental exposure assessment, physical activity assessment, dietary and nutritional assessment, depression assessment, sleep quality assessment and economic burden assessment. Subsequently, objective medical information, obstetric and neonatal outcomes were collected through hospital information system (HIS). To further assess the mothers' and infants' health status, a new multicenter prospective cohort study, including more than 1000 participants of the CPWCS from 5 hospitals of 5 different provinces in China, will be conducted. Through the electronic self-administered questionnaire surveys and laboratory testing methods, information about infants' feeding, sleeping, defecating, oral health, early development and common allergic diseases will be collected. And we will also assess mothers' current health habits and status, such as sleeping, diet, anxiety, physical activity, and oral health. SAS statistical software will be used for data analysis. Ethics and Dissemination Permission for the study was obtained from Chinese Academy of Medical Sciences and Peking Union Medical College. Ethics approval was obtained from the Ethics Review Committee of Department of Scientific Research, School of Basic Medicine, Peking Union Medical College, Beijing, China. The results will be published in peer-reviewed journals or disseminated through conference presentations.

Start: August 2020

Relevance of Ultrasound Screening for Foetal Macrosomia

Management of fetal macrosomia is based on a suspicion of macrosomia (no certainty before birth). This management is an artificial induction of labour for an earlier delivery and therefore a lower fetal weight gain. Several studies have already shown that ultrasound performed during the third trimester of pregnancy was not a perfect tool for this screening.

Start: June 2020

Corneal Biomechanics During Pregnancy

It is known that intraocular pressure changes during pregnancy. Collagen structure changes during pregnancy to enable softening of the symphysis, whitening of the birth chanel, and, thus, ultimately to enable delivery of a child. The cornea consists of highly structured collagen fibers. Hence, it seams logically that corneal biomechanics also change during pregnancy.

Start: January 2016

Feasibility of Medical Abortion by Telemedicine in Mexico

This study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion in Mexico.

Start: April 2019

The Effects of Exercise Training During Pregnancy

Pregnancy is a physiological event that lasts for an average of 280 days or 40 weeks, starting with the embryo formed by the combination of ovum and sperm ready for fertilization. Many anatomical, physiological, social and psychological changes occur in the mother's body during pregnancy. In order to better adapt to these changes and to minimize problems during pregnancy, it is very beneficial for pregnants who do not have medical or obstetric risk to increase their physical activity level and exercise. Training programs created in light of the physical activity guidelines prepared specifically for the gestation period during pregnancy should be followed. For this purpose, pregnant programs have been organized routinely as a group exercise two days a week in Hacettepe University, Physical Therapy and Rehabilitation Faculty, Women's & Men's Health Unit since 1990. The scope of this exercise program includes posture and body mechanics training, strengthening the lower and upper extremities, strengthening the abdominal and back muscles, pelvic floor exercises and breathing exercises. In one training session, 20 different exercises are performed and one session lasts about 60 minutes. For pregnant women with time limitations, sessions with less exercise and lasting about 30 minutes are held. Trainings are started in the 16th week of pregnancy and terminated in the 32nd week. Pregnant women who cannot participate in this group exercise program for personal reasons are given recommendations as home programs. In the literature; There is no specific guide on the type of exercise, intensity, and frequency of the exercise that can affect the thickness of the trunk stabilizer muscles during pregnancy, improve functionality and quality of life. With this study, it is planned to investigate the effects of the exercise protocol applied on the thickness, functionality and quality of life of the body stabilizer muscles in pregnant women who routinely participate in the short or long group exercise program, which starts from the 16th week of pregnancy until the 32nd week of the week. In addition, the pregnant women, who could not participate in the short or long group exercise program and started their home program until the 32nd week of pregnancy and made their routine follow-ups, will be evaluated in the 16th and 32nd weeks of pregnancy. At the end of this study; The change between body stabilizer muscle thickness, functionality and quality of life will be examined in three different groups, which continue routine short or long pregnant exercises and who can not participate in group exercise and follow up with the home program. In addition, data on trunk stabilizer muscle thickness, functionality and quality of life obtained from these three different groups will be compared. Thus, the literature will provide evidence of effective exercise protocols on trunk stabilizer muscle thickness, functionality and quality of life.

Start: February 2020

Effects of High Altitude on AMPK Activation

Pregnancy elicits adaptive changes in uteroplacental blood flow, which are altered at high altitude and may contribute to the observed 3-fold increase in intrauterine growth restriction (IUGR) and preeclampsia (PreE). The investigators propose to collect myometrial, cord blood, and placental tissue samples from women at high altitude (Summit County) and low altitude (Denver) in Colorado in order to determine if residence at altitude during pregnancy changes the vasoreactivity of myometrial arteries (MA). If altered MA vasoreactivity is found, further studies may be able to link these changes to the increased rates of PreE and IUGR at altitude and contribute to the understanding of these two disorders.

Start: January 2016

Eculizumab Use in the Postpartum Period for the Treatment of Pregnancy Associated aHUS: A Case Series

Eculizumab is a humanized monoclonal IgG antibody against protein C5 that works to inhibit the activation of the terminal complement cascade. The Eculizumab is currently FDA approved for the treatment of Paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome (aHUS) and has been shown to improve the quality of life and overall survival in these patients. aHUS is a life-threatening disease of complement mediated thrombotic microangiopathy often triggered by an inciting event, such as an infection or immunocompromised state. Pregnancy has also been identified as an inciting event, with patients most often experiencing aHUS in the postpartum period. Due to its rare nature, pregnancy-associated aHUS is often mistaken for preeclampsia or hemolysis, elevated liver enzyme, low platelet (HELLP) syndrome. As standard treatment for preeclampsia and HELLP syndrome is completion of the pregnancy by expediting delivery of the baby. A missed diagnosis of aHUS can result in delays in treatment, including use of Eculizumab when appropriate; such delay can increase the risk of maternal morbidity and mortality. When aHUS is suspected in the postpartum period, Eculizumab could be initiated early; however, there is limited data on use of Eculizumab in this setting.

Start: April 2018

LimPrOn: Limburg Pre-eclampsia Investigation

Background: Multiple adaptations at the cardiovascular system occurs during pregnancy. In the pregnancy condition pre-eclampsia (PE), this adaptations are abnormal. Five to eight percent of all pregnant women worldwide will develop PE. PE is a pregnancy condition which is characterized with a high blood pressure (>140/90 mm Hg) and the occurrence of proteinuria (>3g/dl/24h) after 20 weeks of gestation. When untreated, this condition can have severe complications for both mother and child. It's important to monitor women with a high risk for developing PE for an early detection and treatment of this condition. For this reason, a multicenter study is set up with the following applications: NICCOMO and Maternal Venous Doppler Echography: impedance cardiograph and an echography of the heart and veins. Maltron: bio-electronic impedance analyze Remote monitoring of the high risk patients to become a more intensive follow-up Number of inclusions: 2000 pregnant women from the prenatal consultations of eight different hospitals:

Start: May 2016