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Completed

NCT Number: NCT01869582

Safer Births - Reducing Perinatal Mortality

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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Key information

Conditions

Fetal Heart Rate Abnormalities Asphyxia Neonatorum Birth Asphyxia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Hypoxia Hypoxia Infant, Newborn, Diseases Neonatal Resuscitation Pathological Conditions, Signs and Symptoms Pregnancy Complications Respiration Disorders Respiratory Depression Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haydom Lutheran Hospital, Research Institute, Haydom, Manyara Region, Tanzania

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fetoscope, Fetal heart rate

Device

Other names: Pinard fetoscope

Upright Resuscitator, Resuscitation

Device

Other names: Laerdal Upright Resuscitator

Doppler, Fetal heart rate

Device

Other names: FreePlay Doppler Ultrasound

Standard Resuscitator, Resuscitation

Device

Other names: Laerdal Neonatal Resuscitator

Primary outcomes

  1. Perinatal Mortality

    Time frame: From start of labour to 7 days postpartum

    Death during or shortly following birth

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • Haydom Lutheran Hospital
  • Laerdal Global Health
  • Muhimbili National Hospital, Tanzania
  • Stavanger Acute medicine Foundation for Education and Research, Norway
  • Weill Cornell Medical Collage, USA

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2013
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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