High Risk Pregnancy

12

Review clinical trials related to High Risk Pregnancy. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Effects of Emotional Freedom Technique and Music Therapy in High-Risk Pregnancy

Pregnancy is a physiological process; however, it is also a dynamic period during which obstetric and medical complications that may threaten maternal and fetal health can occur. In the presence of such complications, pregnancy is defined as a high-risk pregnancy, accounting for approximately 10-20% of all pregnancies. Due to the increased risk of maternal and fetal morbidity and mortality, high-risk pregnancies are considered a significant public health issue. Among high-risk pregnancies, premature rupture of membranes (PROM) and particularly preterm premature rupture of membranes (PPROM) are obstetric conditions associated with serious risks for maternal and perinatal outcomes. PPROM is responsible for a substantial proportion of preterm births and is associated with an increased risk of neonatal complications. During the course of PROM and PPROM, the latency period between membrane rupture and delivery constitutes a significant source of uncertainty and psychosocial burden for pregnant women. Factors such as prolonged hospitalization, risk of complications, and fear of fetal loss may lead to increased levels of stress, anxiety, and depression in this population. In the face of intense stress and uncertainty, coping strategies emerge as an important determinant of psychological outcomes. Coping refers to the cognitive and behavioral efforts individuals employ to manage situations perceived as threatening and is generally classified into active and avoidant coping strategies. Avoidant coping strategies have been associated with higher levels of anxiety and depression, whereas adaptive coping strategies are reported to enhance psychological resilience. Maternal psychological status may influence not only the mother's mental health but also fetal well-being. In this context, the non-stress test (NST) is an important tool for evaluating fetal autonomic nervous system function and allows monitoring of the relationship between maternal psychological status and fetal physiological responses. However, findings regarding the relationship between maternal anxiety and depression and NST parameters remain inconsistent. Current clinical management of PROM and PPROM primarily focuses on preventing obstetric complications, while the maternal psychological dimension often remains secondary. Therefore, safe and feasible non-pharmacological interventions during pregnancy have gained increasing attention. Emotional Freedom Technique (EFT) and music therapy are among the non-pharmacological interventions shown to be effective in reducing stress, anxiety, and depression during pregnancy. However, no studies have been identified in the literature evaluating the effects of these interventions on maternal psychological status, coping strategies, and fetal well-being in high-risk pregnancy groups such as PROM and PPROM. Therefore, randomized controlled trials are needed to evaluate the effects of EFT and music therapy on maternal psychological status, coping strategies, and fetal well-being in pregnant women diagnosed with PPROM.

Participants needed: 177
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Selcuk UniversityUpdated: Apr 30, 2026
Eligibility criteria

Women aged 18 years and older [+6]

Pregnancy achieved via assisted reproductive technologies [+7]

Status: Recruiting

Leg Heating in Pregnant Women With Obesity

Obesity is a major risk factor for hypertensive disorders of pregnancy (HDP). The underlying mechanisms are largely unclear, but maternal vascular endothelial dysfunction is likely involved. Endothelial dysfunction in HDP could be attributed to 1) alterations in the L-arginine/nitric oxide (NO) pathway, and 2) an increase in endothelin-1 (ET-1). Additionally, augmented sympathetic vasoconstriction may also contribute to HDP. Chronic (repeated) whole-body heat exposure has been shown to increase NO bioavailability, decrease ET-1, and cause functional and structural adaptations in the vasculature. All these can improve vascular function, attenuate sympathetic (re)activity, lower blood pressure (BP), and reduce cardiovascular risk in non-pregnant individuals. Whether this is also true after regional (leg) heating in high-risk pregnant women is unknown. The investigators' central hypothesis is that chronic leg heating will be effective in improving vascular endothelial function and attenuating sympathetic vasoconstriction, leading to a reduction of the risk for HDP in pregnant women with obesity. The overarching goal of this proposal is to determine the vascular and neural effects of chronic leg heating in obese pregnancy. The study team plans to enroll pregnant women with obesity between 12-14 weeks of gestation and randomly assign them to either an intervention group or a control group (1:1 ratio). Participants in the intervention group will perform 16 weeks of home-based leg heating using a portable sauna blanket up to the hip (temperature of the blanket will be set at 65°C, 4 times/week, 45 min/session), whereas women in the control group will set the temperature of the blanket at 35°C at the same frequency and duration. Participants will be evaluated at baseline and then at 28-30 weeks of gestation. Aim 1 will determine the effects of chronic leg heating on maternal vascular function and surrogate markers of HDP. Aim 2 will determine the effects of chronic leg heating on sympathetic vasoconstriction and BP. Findings from this project will provide insight on the extent and potential mechanisms of how chronic leg heating works for improving vascular endothelial function and sympathetic vasoconstriction in pregnant women with obesity. Results obtained will set a foundation for future large multicenter clinical trials to determine the efficacy and generalizability of home-based leg heat therapy as a safe, ease-of-use, cost-effective, and non-drug approach for reducing the risk of HDP.

Participants needed: 118
Trial details
Age: 18-45Biological sex: FemaleType: InterventionalSponsor: University of Texas Southwestern Medical CenterUpdated: Apr 17, 2026Locations: 1
Eligibility criteria

Women with overweight or obesity (self-reported pre-pregnancy body mass index ≥2... [+5]

Current multiple pregnancies (e.g., twins, triplets, etc.). [+10]

Status: Recruiting

IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy

This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.

Participants needed: 55
Trial details
Phase: Phase 2Age: 18-40Biological sex: FemaleType: InterventionalSponsor: David Ware BranchUpdated: Apr 1, 2026Locations: 3
Eligibility criteria

Pregnant as defined by positive test for elevated ß-HCG and having a live, appro... [+4]

Hypertension (BP >140/90) present at screening; [+17]

Status: Recruiting

Remote Fetal Monitoring in High Risk Pregnancies

Antenatal nonstress tests (NSTs) are performed to assess fetal health and are used as a cost-effective test that can be widely administered. However, an NST is operator-dependent due to the nature of Doppler ultrasound and is primarily performed in a clinic and hospital setting. The ability to conduct a clinically valuable test at home would address access to care issues faced by numerous women in the United States and reduce the workload on healthcare clinicians facing a shortage of human resources. This pilot study aims to assess the feasibility and acceptability of home NST monitoring in order to determine whether femomTM could be utilized as an adjunct to routine prenatal care. Patients with high risk pregnancies who are recommended to undergo at least once weekly at 32 weeks testing by the obstetrician will be recruited for participation in this study. Participants will be asked to perform three 30 minute monitoring sessions weekly starting at 32 weeks for 6 weeks.

Participants needed: 50
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Beth Israel Deaconess Medical CenterUpdated: Mar 9, 2026Locations: 1
Eligibility criteria

Intrauterine pregnancy greater than 32 weeks gestation [+2]

Under age 18 years of old [+1]

Status: Recruiting

Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise

Each year world-wide, 2.5 million fetuses die unexpectedly in the last half of pregnancy, 25,000 in the United States, making fetal demise ten-times more common than Sudden Infant Death Syndrome. This study will apply a novel type of non-invasive monitoring, called fetal magnetocardiography (fMCG) used thus far to successfully evaluate fetal arrhythmias, in order to discover potential hidden electrophysiologic abnormalities that could lead to fetal demise in five high-risk pregnancy conditions associated with fetal demise.

Participants needed: 30
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Medical College of WisconsinUpdated: Mar 4, 2026Locations: 2
Eligibility criteria

Current pregnancy complicated by one of the five diagnostic categories [+10]

Severe claustrophobia not reduced by taking breaks, or by having the light on, o... [+6]

Status: Not yet recruiting

Tele-Supported Motor Imagery Exercise in High-Risk Pregnancy

High-risk pregnancy is defined as a pregnancy in which there is an increased likelihood of adverse maternal and/or fetal outcomes due to maternal or fetal conditions. The global prevalence of high-risk pregnancies ranges between 10% and 60%. In cases where pregnancy complications occur, bed rest is frequently recommended to prevent further deterioration. However, prolonged inactivity may lead to unfavorable maternal outcomes, and appropriately prescribed exercise may help reduce the negative consequences of immobility. Long-term maternal exercise has been shown to promote vascular remodeling and angiogenesis in the uterine and umbilical arteries, increase vessel diameter, and reduce vascular resistance. Previous studies have demonstrated that exercise reduces the risk of gestational diabetes, preeclampsia, gestational hypertension, and macrosomia without increasing the risk of preterm birth, low birth weight, or perinatal mortality. Despite these benefits, women with high-risk pregnancies may have different perceptions and concerns regarding physical activity compared to healthy pregnant women. Motor imagery is a mental process in which an individual cognitively rehearses a movement without performing it physically. Neuroimaging studies have demonstrated activation of similar brain regions during motor imagery and actual movement. Mental imagery-guided relaxation exercises have been shown to improve maternal anxiety, stress levels, fetal attachment, and blood pressure in both healthy and hypertensive pregnancies. Recent findings also indicate that motor imagery-based exercise combined with diaphragmatic breathing does not adversely affect the fetus in high-risk pregnancies and may improve maternal well-being and oxygen saturation without inducing uterine contractions. This randomized controlled trial aims to investigate the maternal and fetal effects of an 8-week tele-rehabilitation-supported motor imagery-based exercise program in high-risk pregnant women who are prescribed hospital- or home-based bed rest.

Participants needed: 38
Trial details
Age: 18-45Biological sex: FemaleType: InterventionalSponsor: Izmir University of EconomicsUpdated: Feb 20, 2026Locations: 1
Eligibility criteria

Obstetric conditions associated with adverse outcomes and physical activity rest... [+3]

Pregnant women with conditions such as gestational diabetes mellitus or pregnanc... [+5]

Status: Recruiting

UCLA Perinatal Biospecimen Repository

The purpose of this investigator-initiated prospective observational cohort study is to establish the new UCLA Perinatal Biospecimen Repository (Perinatal Repository) for collection, storage, and distribution of the human data and biospecimens of the participants with perinatal pathology. The secure and shared high-quality resource of clinical data and biological specimens (Repository Materials), across pregnancy pathology related to research protocols at the Afshar's Lab will be created. Core variables of interest include clinical characteristics and relevant biological samples. Intention to collect perinatal data is aiding the efficiency and effectiveness of de-identified biorepository for pregnancy-at-risk outcome research. The primary aims of the project are: * To design the Case Report Forms (CRFs) for the clinical and biospecimen data. * To create and update the project-specific policies, agreements, and Standard Operating Procedures (SOPs). * To develop the data management system to assure personal health information de-identification, data integrity, participants welfare, and protocol compliance. * To develop and implement a quality management system for the Repository. * To collect and record in the Repository protocol-related clinical information. * To organize a consistent system to bank high-quality biospecimens while protecting participant-donor safety and privacy. * To establish the policies and procedures for Repository Materials dissemination and research collaboration. * To analyze the scientific results of the Repository creation. The secondary aim of the study is to provide a mechanism to store and share for research purposes the de-identified biospecimen and information about participants at risk for adverse pregnancy outcomes.

Participants needed: 1,000
Trial details
Age: 1+Biological sex: AllType: ObservationalSponsor: Yalda Afshar, MD, PhDUpdated: Dec 29, 2025Locations: 1Duration: 5 Years
Eligibility criteria

Pregnant and postpartum birthing persons aged 18 and over with perinatal patholo... [+2]

Pregnant and postpartum birthing person unwilling to give written informed conse...

Status: Recruiting

Effect of Hypnobreastfeeding Education in High-Risk Pregnant Women

It is thought that hypnobreastfeeding training given to high-risk pregnant women will reduce anxiety levels, increase lactation, encourage breastfeeding, reduce the perception of insufficient milk, and facilitate adaptation to the postpartum breastfeeding process. According to the results of the power analysis, at least 68 high-risk pregnant women, 34 experimental and 34 control, should be included in the study. Data will be collected with the "Pregnancy Information Form", "Anxiety Assessment Scale", " Infant Feeding Intention Instrument", "Postpartum Information Form", "Perception of Insufficient Milk Questionnaire" and "Breastfeeding Adaptation Scale". In the research, hypnobreastfeeding training will be applied by the researcher to the high-risk pregnant women in the experimental group.

Participants needed: 68
Trial details
Biological sex: FemaleType: InterventionalSponsor: Amasya UniversityUpdated: Dec 15, 2025Locations: 1
Eligibility criteria

High-risk primiparous pregnant women [+3]

Those with communication disabilities [+6]

Status: Not yet recruiting

AI-Powered CURAᵀᴹ Application for Identifying At-Risk Pregnancies in Obstetric Management

It is important to identify high pregnancies early through screening so that appropriate care and intervention may be instituted. An AI-assisted risk categorisation approach may be advantageous compared with traditional means of screening. The purpose of this study is to determine if the adoption of an AI-assisted approach in general pregnancy risk screening will improve the accuracy of antenatal risk categorization into high- and low- risk pregnancy groups, ultimately resulting in fewer poor maternal and fetal/neonatal outcomes.

Participants needed: 1,700
Trial details
Age: 21-50Biological sex: FemaleType: InterventionalSponsor: National University Hospital, SingaporeUpdated: Jul 15, 2025Locations: 1
Eligibility criteria

Age: 21 years old to 50 years old [+3]

Not proficient in the English language (AI intervention is only available in Eng...

Status: Recruiting

Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies

Despite advances in obstetric care, preeclampsia (PE) remains the leading cause of maternal death and disability in both developed and developing countries, contributing to over 70,000 maternal and 500,000 fetal deaths annually worldwide. PULSE was designed using a preventative medicine approach, focusing on improving early detection of PE as opposed to managing symptoms after onset. The study aims to uncover the earliest possible signs of PE using a combination of novel clinical tools and established diagnostic techniques to better identify, track, and manage high risk pregnant women. Specifically, PULSE will be examining the incorporation of a non-invasive test for the measurement of arterial stiffness, which has been shown to be predictive of hypertensive disorders. This test, in combination with a wide range of blood biomarkers, detailed ultrasound imaging, and a comprehensive battery of physical and mental health questionnaires, represents the largest, most comprehensive preventative PE study to date. The results of this work has the potential to revolutionize the way PE and other hypertensive disorders of pregnancy are managed and treated and can serve to inform the design of future preventative clinical research studies.

Participants needed: 2,400
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreUpdated: Apr 18, 2025Locations: 1
Eligibility criteria

Singleton pregnancy [+1]

>14 weeks gestation [+3]

Status: Recruiting

Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China

Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China (ChiTwiMC) is supported by National Key Research and Development Program of China - Reproductive Health and Women's and Children's Health Protection Project. This project is funded by the Ministry of Science and Technology of China under grant number 2023YFC2705900. The ChiTwiMC cohort is led by Professor Wei Yuan from the Department of Gynecology and Obstetrics at Peking University Third Hospital.

Participants needed: 2,000
Trial details
Age: 18-45Biological sex: FemaleType: ObservationalSponsor: Peking University Third HospitalUpdated: May 16, 2024Locations: 11
Eligibility criteria

Twin pregnancies [+4]

Women with mental disorders or serious maternal illness that is not eligible to... [+2]

Status: Not yet recruiting

Verify the Safety and Effectiveness of the Cerclage Pessary in Prevention and Treatment of High-risk Preterm Pregnancy

Verify the safety and effectiveness of the cerclage pessary in the prevention and treatment of high-risk preterm pregnancy.

Participants needed: 300
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: QH Medical Technology Ltd.Updated: Nov 18, 2023
Eligibility criteria

Women with a pregnancy and a history of at least one spontaneous preterm birth b... [+3]

The previous preterm delivery is iatrogenic proterm labor [+13]