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Safer Births - Reducing Perinatal Mortality

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Helse Stavanger HF
Sponsor:
Collaborators:
Muhimbili National Hospital, Tanzania
Haydom Lutheran Hospital, Tanzania
Stavanger Acute medicine Foundation for Education and Research, Norway
Weill Cornell Medical Collage, USA
Laerdal Global Health, Norway
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01869582
First received: May 24, 2013
Last updated: February 23, 2016
Last verified: February 2016
  Purpose

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.


Condition Intervention
Fetal Heart Rate Abnormalities
Respiratory Depression
Birth Asphyxia
Neonatal Resuscitation
Device: Fetoscope, Fetal heart rate
Device: Upright Resuscitator, Resuscitation
Device: Doppler, Fetal heart rate
Device: Standard Resuscitator, Resuscitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safer Births - New Knowledge and Innovations to Decrease Perinatal Mortality and Morbidity Worldwide

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Perinatal Mortality [ Time Frame: From start of labour to 7 days postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 20000
Study Start Date: April 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doppler, Fetal heart rate
Eligible women in labour randomized to intermittent fetal heart rate assessments using a wind-up, hand-held Doppler
Device: Doppler, Fetal heart rate
Other Name: FreePlay Doppler Ultrasound
Experimental: 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
Device: Fetoscope, Fetal heart rate
Other Name: Pinard fetoscope
Experimental: Upright Resuscitator, Resuscitation
Non-breathing newborn infants in need of positive pressure ventilation randomized to an Upright Resuscitator
Device: Upright Resuscitator, Resuscitation
Other Name: Laerdal Upright Resuscitator
Experimental: 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
Device: Standard Resuscitator, Resuscitation
Other Name: Laerdal Neonatal Resuscitator

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869582

Contacts
Contact: Hege L Ersdal, MD, PhD +4799647822 hege.ersdal@safer.net
Contact: Hussein L Kidanto, MD, PhD +255 748 462478 hkidanto@yahoo.co.uk

Locations
Tanzania
Haydom Lutheran Hospital, Research Institute Recruiting
Haydom, Manyara, Tanzania, 9041
Contact: Hege L Ersdal, MD, PhD    +4799647822    hege.ersdal@safer.net   
Contact: Estomih R Mduma, Manager       estomih.mduma@haydom.co.tz   
Principal Investigator: Estomih R Mduma, Manager         
Muhimbili National Hospital Recruiting
Dar es Salaam, Tanzania, 65439
Contact: Hussein L Kidanto, MD, PhD    +255 748 462478    hkidanto@yahoo.co.uk   
Principal Investigator: Hussein L Kidanto, MD, PhD         
Sponsors and Collaborators
Helse Stavanger HF
Muhimbili National Hospital, Tanzania
Haydom Lutheran Hospital, Tanzania
Stavanger Acute medicine Foundation for Education and Research, Norway
Weill Cornell Medical Collage, USA
Laerdal Global Health, Norway
Investigators
Principal Investigator: Hege L Ersdal, MD, PhD Helse Stavanger HF
Principal Investigator: Hussein L Kidanto, MD, PhD Muhimbili National Hospital
Principal Investigator: Estomih R Mduma, Manager Haydom Lutheran Hospital
  More Information

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01869582     History of Changes
Other Study ID Numbers: Safer Births 
Study First Received: May 24, 2013
Last Updated: February 23, 2016
Health Authority: Tanzania: National Institute for Medical Research
Tanzania: Ministry of Health

Keywords provided by Helse Stavanger HF:
Fetal hypoxia
Birth asphyxia
Neonatal resuscitation

Additional relevant MeSH terms:
Asphyxia Neonatorum
Asphyxia
Respiratory Insufficiency
Perinatal Death
Death
Pathologic Processes
Wounds and Injuries
Respiration Disorders
Respiratory Tract Diseases
Pregnancy Complications
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 27, 2016