Safer Births

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2018-04-30

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.

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Detailed Description

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Conditions

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Fetal Heart Rate Abnormalities Respiratory Depression Birth Asphyxia Neonatal Resuscitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Doppler, Fetal heart rate

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

Group Type EXPERIMENTAL

Doppler, Fetal heart rate

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

Fetoscope, Fetal heart rate

Intervention Type DEVICE

Upright Resuscitator, Resuscitation

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

Group Type EXPERIMENTAL

Upright Resuscitator, Resuscitation

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

Standard Resuscitator, Resuscitation

Intervention Type DEVICE

Interventions

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Fetoscope, Fetal heart rate

Intervention Type DEVICE

Upright Resuscitator, Resuscitation

Intervention Type DEVICE

Doppler, Fetal heart rate

Intervention Type DEVICE

Standard Resuscitator, Resuscitation

Intervention Type DEVICE

Other Intervention Names

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Pinard fetoscope Laerdal Upright Resuscitator FreePlay Doppler Ultrasound Laerdal Neonatal Resuscitator

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