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NCT01869582 Clinical Trial

Safer Births - Reducing Perinatal Mortality

Respiratory Depression Clinical Trial

Official title:
Safer Births - New Knowledge and Innovations to Decrease Perinatal Mortality and Morbidity Worldwide

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01869582
Other study ID # Safer Births
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2013
Est. completion date April 2018

Study information
Verified date May 2017
Source Helse Stavanger HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20000
Est. completion date April 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Fetoscope, Fetal heart rate

• Upright Resuscitator, Resuscitation

• Doppler, Fetal heart rate

• Standard Resuscitator, Resuscitation

Locations
Country Name City State
Tanzania Muhimbili National Hospital Dar es Salaam
Tanzania Haydom Lutheran Hospital, Research Institute Haydom Manyara

Sponsors (6)
Lead Sponsor Collaborator
Helse Stavanger HF Haydom Lutheran Hospital, Laerdal Global Health, Muhimbili National Hospital, Tanzania, Stavanger Acute medicine Foundation for Education and Research, Norway, Weill Cornell Medical Collage, USA

Country where clinical trial is conducted

Tanzania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Perinatal Mortality Death during or shortly following birth From start of labour to 7 days postpartum
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