Safer Births - Reducing Perinatal Mortality

May 11, 2020 updated by: Helse Stavanger HF

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Dar es Salaam, Tanzania, 65439
        • Muhimbili National Hospital
    • Manyara
      • Haydom, Manyara, Tanzania, 9041
        • Haydom Lutheran Hospital, Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Laerdal Neonatal Resuscitator

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

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

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

June 1, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 11, 2020

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Safer Births

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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