Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03249896 - Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes 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
Active, not recruiting NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
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
Recruiting NCT06250192 - Educational TOolS for Pregnant Women With Diabetes Mellitus. N/A
Active, not recruiting NCT05980650 - Reiki Effect on Risky Pregnants in Terms of Holistic Well-being, Prenatal, Maternal Attachment and Physical Symptoms N/A
Completed NCT03509805 - Sleep Apnea Syndrome in Obese Women During Pregnancy N/A