Safer Births - Reducing Perinatal Mortality

Not Applicable

Completed

• Conditions: Fetal Heart Rate Abnormalities; Birth Asphyxia; Respiratory Depression; Neonatal Resuscitation
• Interventions: Device: Fetoscope, Fetal heart rate; Device: Doppler, Fetal heart rate; Device: Upright Resuscitator, Resuscitation; Device: Standard Resuscitator, Resuscitation

• Registration Number: NCT01869582
• Lead Sponsor: Helse Stavanger HF

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-06-01
• Study First Posted: 2013-06-05
• Status Verified: 2017-05
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20000

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Fetoscope, Fetal heart rate	Fetoscope, Fetal heart rate	Eligible women in labour randomized to intermittent fetal heart rate assessments using a Pinard fetoscope, which is the current standard management
Doppler, Fetal heart rate	Doppler, Fetal heart rate	Eligible women in labour randomized to intermittent fetal heart rate assessments using a wind-up, hand-held Doppler
Upright Resuscitator, Resuscitation	Upright Resuscitator, Resuscitation	Non-breathing newborn infants in need of positive pressure ventilation randomized to an Upright Resuscitator
Standard Resuscitator, Resuscitation	Standard Resuscitator, Resuscitation	Non-breathing newborn infants in need of positive pressure ventilation randomized to a standard horizontal Resuscitator, which is the current standard management

Primary Outcome Measures

Name	Time	Method
Perinatal Mortality	From start of labour to 7 days postpartum	Death during or shortly following birth

Trial Locations

Locations (2)

Muhimbili National Hospital; 🇹🇿 Dar es Salaam, Tanzania

Haydom Lutheran Hospital, Research Institute; 🇹🇿 Haydom, Manyara, Tanzania