Safer Births - Reducing Perinatal Mortality

Study Overview
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Brief Summary
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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.

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

Conditions
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Fetal Heart Rate Abnormalities, Respiratory Depression, Birth Asphyxia, Neonatal Resuscitation

Intervention / Treatment
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* Device: Fetoscope, Fetal heart rate
* Device: Upright Resuscitator, Resuscitation
* Device: Doppler, Fetal heart rate
* Device: Standard Resuscitator, Resuscitation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doppler, Fetal heart rate<br>Eligible women in labour randomized to intermittent fetal heart rate assessments using a wind-up, hand-held Doppler | Device: Doppler, Fetal heart rate<br> <br> * Other names: FreePlay Doppler Ultrasound;|
| Experimental: Fetoscope, Fetal heart rate<br>Eligible women in labour randomized to intermittent fetal heart rate assessments using a Pinard fetoscope, which is the current standard management | Device: Fetoscope, Fetal heart rate<br> <br> * Other names: Pinard fetoscope;|
| Experimental: Upright Resuscitator, Resuscitation<br>Non-breathing newborn infants in need of positive pressure ventilation randomized to an Upright Resuscitator | Device: Upright Resuscitator, Resuscitation<br> <br> * Other names: Laerdal Upright Resuscitator;|
| Experimental: Standard Resuscitator, Resuscitation<br>Non-breathing newborn infants in need of positive pressure ventilation randomized to a standard horizontal Resuscitator, which is the current standard management | Device: Standard Resuscitator, Resuscitation<br> <br> * Other names: Laerdal Neonatal Resuscitator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal Mortality | Death during or shortly following birth | From start of labour to 7 days postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetal hypoxia, Birth asphyxia, Neonatal resuscitation