Birth Asphyxia, Fetal Heart Rate Abnormalities, Neonatal Resuscitation, Respiratory Depression
Conditions
Keywords
Fetal hypoxia, Birth asphyxia, Neonatal resuscitation
Brief summary
Safer Births is a research and development collaboration to establish new knowledge and new innovative products to better equip and increase competence of health workers for safer births and increased newborn survival worldwide. The main objectives are: To randomize different devices for fetal heart rate assessments. To assess if a novel Newborn Resuscitation Monitor will facilitate newborn resuscitation in a low-resource setting. To determine bag mask ventilation treatment and devices beneficial for neonatal outcome.
Interventions
DEVICEFetoscope, Fetal heart rate
DEVICEUpright Resuscitator, Resuscitation
DEVICEDoppler, Fetal heart rate
DEVICEStandard Resuscitator, Resuscitation
Sponsors
Muhimbili National Hospital, Tanzania
Haydom Lutheran Hospital
Stavanger Acute medicine Foundation for Education and Research, Norway
Weill Cornell Medical Collage, USA
Laerdal Global Health
Helse Stavanger HF
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Randomizing fetal heart rate assessment: Singleton delivery, Term gestation age, Cephalic presentation, Fetal heart rate normal, Cervical dilatation ≤7cm, Consent to participate * Randomizing bag mask ventilation: infants in need of positive pressure ventilation, Consent to participate
Exclusion criteria
* Randomizing fetal heart rate assessment: Placenta abruption/praevia, Ruptured uterus, Morbid Obesity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perinatal Mortality | From start of labour to 7 days postpartum | Death during or shortly following birth |
Countries
Tanzania
Outcome results
None listed