Skip to content

Umbiflow Device to identify high risk fetus

Prevalence and outcomes of abnormal continuous wave Doppler flow indices in unselected obstetric populations in low- and middle income countries: The Umbiflowâ?¢ International Study (A65924)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/07/014863
Enrollment
7035
Registered
2018-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O099- Supervision of high risk pregnancy, unspecified

Interventions

Intervention1: Umbiflow continuous-wave Doppler device: Umbiflow is a handheld, mobile continuous-wave Doppler ultrasound device, which consists of a handheld proprietary Doppler probe (transducer) wi

Sponsors

World Health Organization
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Singleton pregnancy 2. Accurate gestational age between more than or equal to 28 weeks 0 days and less than or equal to 34 weeks 0 daysâ?? gestation. 3. Women expected to give birth in study hospital or its catchment area 4. Women currently considered as â??low riskâ?? according to local antenatal care guidelines

Exclusion criteria

Exclusion criteria: 1. Multiple pregnancy 2. Women not expected to give birth in study hospital or likely to migrate from its catchment area 3. Pregnant women who are incapable of giving informed consent or assent for any reason.

Design outcomes

Primary

MeasureTime frame
Prevalence of Abnormal flow indices as assessed by Umbiflow-resistance Index, pulsatility index, systolic or diastolic ratio Prevalence of Absent End Diastolic FlowTimepoint: 28 weeks of gestation to 7 days postpartum

Secondary

MeasureTime frame
Birth outcomes 1 Onset of labour (spontaneous or induced) 2 Mode of birth-vaginal, assisted vaginal or caesarean 3 Gestational age at birth 4 Birthweight Timepoint: until 7 days postpartum;Fetal and neonatal outcomes 1 Stillbirth- macerated and fresh stillbirth more than or equal to 28 weeks gestation 2 Early neonatal death 3 Perinatal mortality-stillbirths and early neonatal deaths 4 Small for Gestational Age -Birthweight less than 10th centile according to local growth charts 5 Ponderal indexTimepoint: up to day 7 postnatal or discharge;Maternal pregnancy outcomes 1 Maternal morbidity outcomes 2 Maternal mortalityTimepoint: 28 weeks of gestation to 7 days postpartum;Use of investigations, interventions and health systems outcomes 1 Referral of women to higher level of care 2 Completed referral 3 Number, timing and care provider of antenatal care visits 4 Hospital admission 5 Number, timing and findings of ultrasound assessments-like biophysical profile, UA Doppler 6 Antenatal corticosteroids 7 Planned provider-initiated deliveryTimepoint: 28 weeks of gestation to 7 days postpartum

Countries

Ghana, India, Kenya, Rwanda, South Africa

Contacts

Public ContactDr Yeshita V Pujar

J N Medical College

yvpujar@hotmail.com9448142989

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026