Safer Births - Reducing Perinatal Mortality

Helse Stavanger HF20,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

20,000

Conditions

Fetal Heart Rate Abnormalities Respiratory Depression Birth Asphyxia Neonatal Resuscitation

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (2)

Haydom Lutheran Hospital, Research Institute

Haydom, Manyara Region, Tanzania

Muhimbili National Hospital

Dar es Salaam, Tanzania

Outcomes

Primary Outcomes

Perinatal Mortality

Death during or shortly following birth

Time frame: From start of labour to 7 days postpartum