Pregnancy and Childbirth
Conditions
Interventions
Wekebere Intervention
Standard of care
Sponsors
Vilgro Africa
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: i. Female age between: 18-50 ii. Gestational age >36 + 0 weeks iii. Singleton pregnancy iv. Early labour (cervical dilatation of <6cm) v. Sign informed consent
Exclusion criteria
Exclusion criteria: i. Female age between: 18-50 ii. Gestational age >36 + 0 weeks iii. Singleton pregnancy iv. Early labour (cervical dilatation of <6cm) v. Sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Performance outcome: The primary performance outcome will be Fetal HR. This outcome will be collected via Wekebere fetal monitoring system and via the standard of care monitoring system (Doppler). ;Incidence of device related and/or protocol procedure related adverse events and/ or serious adverse events related to the study device, in pregnant women with singleton pregnancy > 36 + 0 weeks of gestation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary performance endpoints will include be Uterine contractions. Wekebere fetal monitoring system also acquires and displays the UA (Uterine contractions) from the uterine Electro hysterography (EHG) signal. Contractions will be collected by wekebere fetal monitoring system and via the standard of care monitoring system (partograph). | — |
Countries
Uganda
Contacts
Public ContactGerald Abaho
Product Engineer
Outcome results
None listed