Echocardiographic Screening of Pregnant Women During Antenatal Care

Status Recruiting

Clinical Trial Summary

Non-obstetrical drivers of adverse pregnancy outcomes are underappreciated. Latent structural heart disease may account for a substantial proportion of adverse pregnancy outcomes in low-resource settings. Pregnant women presenting to B.P. Koirala Institute of Health Sciences will be prospectively included into a registry upon their visit for antenatal care. Women will be followed until 6 weeks after the time of delivery. Nested within this registry, the investigators will perform a registry-based adaptive cluster randomized crossover trial. The trial compares an experimental condition (echocardiographic screening) and a control condition (routine antenatal care).

Clinical Trial Description

Latent structural heart disease may result in complications during pregnancy and delivery. Echocardiographic screening of pregnant women allows for timely detection of structural heart disease in women that may complicate delivery and jeopardize the health and well-being of both the mother and the newborn. In a setting of high rates of latent rheumatic heart disease, with particular high prevalence among women, systematic echocardiographic screening may be a pragmatic approach to prevent adverse clinical outcome related to valvular heart failure. Systematic echocardiographic screening proved to be effective among children in endemic regions. The present study is a registry-based, adaptive cluster randomized crossover trial. The trial will be nested into a registry of pregnant women presenting for routine antenatal care. The experimental condition will be echocardiographic screening. The control condition will be no echocardiographic screening. In the experimental condition, all pregnant women presenting for routine antenatal care will be offered transthoracic echocardiographic screening for the detection of latent structural heart disease. In the control condition, pregnant women will undergo routine antenatal care with echocardiography only when clinically indicated. Ascertainment of the primary endpoint will be performed at hospital discharge after delivery and will rely on routinely collected data. All events will be independently adjudicated by an expert panel of pediatricians, cardiologists and gynecologists. The randomization relates solely to the detection of rheumatic heart disease, while treatment follows guideline recommendations. It is important to note, that all women both in the experimental arm and the control arm detected to have heart disease will undergo optimal medical management during pregnancy and delivery according to the most recent guidelines. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04936815
Study type	Interventional
Source	University Hospital Inselspital, Berne
Contact	Surendra Uranw, MPH
Phone	00977 9842042705
Email	surendra.uranw@bpkihs.edu
Status	Recruiting
Phase	N/A
Start date	December 1, 2021
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03249896` - Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes	N/A
Completed	`NCT06338254` - Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women	N/A
Recruiting	`NCT04825093` - Vitamin D Supplementarion in Pregnant Women at Risk and COVID-19	N/A
Completed	`NCT04739462` - SMS Maama Project COVID-19	N/A
Recruiting	`NCT04519593` - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma	N/A
Recruiting	`NCT03313024` - Berlin-Brandenburg Pregnancy Cohort
Completed	`NCT02577536` - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting	`NCT06430853` - Psychobiological Interventions in Pregnancy	N/A
Not yet recruiting	`NCT06357962` - Semi-permanent Acupuncture Effect on Cervical Ripening	N/A
Not yet recruiting	`NCT03661749` - Urinary Protein to Creatinine Ratio in Term Pregnant Women	N/A
Completed	`NCT02970721` - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Completed	`NCT02191774` - Medical Abortion up to 10 Weeks Gestation at Home
Completed	`NCT01322529` - Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be	N/A
Completed	`NCT00746551` - Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment	Phase 4
Completed	`NCT00678080` - Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes	N/A
Completed	`NCT00634530` - Impact of a Nutritional Intervention Program for Weight Control During Pregnancy	N/A
Completed	`NCT00197561` - Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection	Phase 3
Completed	`NCT05527327` - Pannus Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot Study	N/A
Recruiting	`NCT05551078` - Thrombophilia Screening After Severe IUGR
Recruiting	`NCT03100084` - PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome