Safer Births - Reducing Perinatal Mortality

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.

Conditions

• Fetal Heart Rate Abnormalities
• Respiratory Depression
• Birth Asphyxia
• Neonatal Resuscitation

Interventions

DEVICE

Fetoscope, Fetal heart rate

DEVICE

Upright Resuscitator, Resuscitation

DEVICE

Doppler, Fetal heart rate

DEVICE

Standard Resuscitator, Resuscitation

Sponsors & Collaborators

• Muhimbili National Hospital, Tanzania

  collaborator UNKNOWN

• Haydom Lutheran Hospital

  collaborator OTHER

• Stavanger Acute medicine Foundation for Education and Research, Norway

  collaborator UNKNOWN

• Weill Cornell Medical Collage, USA

  collaborator UNKNOWN

• Laerdal Global Health

  collaborator OTHER

• Helse Stavanger HF

  lead OTHER_GOV

Principal Investigators

• Hege L Ersdal, MD, PhD · Helse Stavanger HF

• Hussein L Kidanto, MD, PhD · Muhimbili National Hospital

• Estomih R Mduma, Manager · Haydom Lutheran Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2018-04-30

Completion

2018-04-30

Countries

• Tanzania

Study Locations