Safer Births - Reducing Perinatal Mortality

Helse Stavanger HF

Status: Completed

Conditions: Fetal Heart Rate Abnormalities; Respiratory Depression; Birth Asphyxia; Neonatal Resuscitation

Treatments: Device: Standard Resuscitator, Resuscitation; Device: Doppler, Fetal heart rate; Device: Fetoscope, Fetal heart rate; Device: Upright Resuscitator, Resuscitation

Study type: Interventional

Funder types: Other

Identifiers

NCT01869582

Safer Births

Details and patient eligibility

About

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.

Enrollment: 20,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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20,000 participants in 4 patient groups

Doppler, Fetal heart rate

Experimental group

Description:

Eligible women in labour randomized to intermittent fetal heart rate assessments using a wind-up, hand-held Doppler

Treatment:

Device: Doppler, Fetal heart rate

Fetoscope, Fetal heart rate

Experimental group

Description:

Eligible women in labour randomized to intermittent fetal heart rate assessments using a Pinard fetoscope, which is the current standard management

Treatment:

Device: Fetoscope, Fetal heart rate

Upright Resuscitator, Resuscitation

Experimental group

Description:

Non-breathing newborn infants in need of positive pressure ventilation randomized to an Upright Resuscitator

Treatment:

Device: Upright Resuscitator, Resuscitation

Standard Resuscitator, Resuscitation

Experimental group

Description:

Non-breathing newborn infants in need of positive pressure ventilation randomized to a standard horizontal Resuscitator, which is the current standard management

Treatment:

Device: Standard Resuscitator, Resuscitation