ClinicalTrials.gov
ClinicalTrials.gov Menu

Safer Births - Reducing Perinatal Mortality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01869582
Recruitment Status : Recruiting
First Posted : June 5, 2013
Last Update Posted : May 19, 2017
Sponsor:
Collaborators:
Muhimbili National Hospital, Tanzania
Haydom Lutheran Hospital
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

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.


Condition or disease Intervention/treatment Phase
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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safer Births - New Knowledge and Innovations to Decrease Perinatal Mortality and Morbidity Worldwide
Actual Study Start Date : March 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Perinatal Mortality [ Time Frame: From start of labour to 7 days postpartum ]
    Death during or shortly following birth



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01869582     History of Changes
Other Study ID Numbers: Safer Births
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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