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Safer Births - Reducing Perinatal Mortality

Primary Purpose

Fetal Heart Rate Abnormalities, Respiratory Depression, Birth Asphyxia

Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Fetoscope, Fetal heart rate
Upright Resuscitator, Resuscitation
Doppler, Fetal heart rate
Standard Resuscitator, Resuscitation
Sponsored by
Helse Stavanger HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Heart Rate Abnormalities focused on measuring Fetal hypoxia, Birth asphyxia, Neonatal resuscitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haydom Lutheran Hospital, Research Institute
  • Muhimbili National Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Doppler, Fetal heart rate

Fetoscope, Fetal heart rate

Upright Resuscitator, Resuscitation

Standard Resuscitator, Resuscitation

Arm Description

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

Eligible women in labour randomized to intermittent fetal heart rate assessments using a Pinard fetoscope, which is the current standard management

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

Non-breathing newborn infants in need of positive pressure ventilation randomized to a standard horizontal Resuscitator, which is the current standard management

Outcomes

Primary Outcome Measures

Perinatal Mortality
Death during or shortly following birth

Secondary Outcome Measures

Full Information

First Posted
May 24, 2013
Last Updated
May 11, 2020
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
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1. Study Identification

Unique Protocol Identification Number
NCT01869582
Brief Title
Safer Births - Reducing Perinatal Mortality
Official Title
Safer Births - New Knowledge and Innovations to Decrease Perinatal Mortality and Morbidity Worldwide
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Heart Rate Abnormalities, Respiratory Depression, Birth Asphyxia, Neonatal Resuscitation
Keywords
Fetal hypoxia, Birth asphyxia, Neonatal resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Doppler, Fetal heart rate
Arm Type
Experimental
Arm Description
Eligible women in labour randomized to intermittent fetal heart rate assessments using a wind-up, hand-held Doppler
Arm Title
Fetoscope, Fetal heart rate
Arm Type
Experimental
Arm Description
Eligible women in labour randomized to intermittent fetal heart rate assessments using a Pinard fetoscope, which is the current standard management
Arm Title
Upright Resuscitator, Resuscitation
Arm Type
Experimental
Arm Description
Non-breathing newborn infants in need of positive pressure ventilation randomized to an Upright Resuscitator
Arm Title
Standard Resuscitator, Resuscitation
Arm Type
Experimental
Arm Description
Non-breathing newborn infants in need of positive pressure ventilation randomized to a standard horizontal Resuscitator, which is the current standard management
Intervention Type
Device
Intervention Name(s)
Fetoscope, Fetal heart rate
Other Intervention Name(s)
Pinard fetoscope
Intervention Type
Device
Intervention Name(s)
Upright Resuscitator, Resuscitation
Other Intervention Name(s)
Laerdal Upright Resuscitator
Intervention Type
Device
Intervention Name(s)
Doppler, Fetal heart rate
Other Intervention Name(s)
FreePlay Doppler Ultrasound
Intervention Type
Device
Intervention Name(s)
Standard Resuscitator, Resuscitation
Other Intervention Name(s)
Laerdal Neonatal Resuscitator
Primary Outcome Measure Information:
Title
Perinatal Mortality
Description
Death during or shortly following birth
Time Frame
From start of labour to 7 days postpartum

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hege L Ersdal, MD, PhD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hussein L Kidanto, MD, PhD
Organizational Affiliation
Muhimbili National Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Estomih R Mduma, Manager
Organizational Affiliation
Haydom Lutheran Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haydom Lutheran Hospital, Research Institute
City
Haydom
State/Province
Manyara
ZIP/Postal Code
9041
Country
Tanzania
Facility Name
Muhimbili National Hospital
City
Dar es Salaam
ZIP/Postal Code
65439
Country
Tanzania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29728142
Citation
Mdoe PF, Ersdal HL, Mduma ER, Perlman JM, Moshiro R, Wangwe PT, Kidanto H. Intermittent fetal heart rate monitoring using a fetoscope or hand held Doppler in rural Tanzania: a randomized controlled trial. BMC Pregnancy Childbirth. 2018 May 4;18(1):134. doi: 10.1186/s12884-018-1746-9.
Results Reference
derived
PubMed Identifier
28427883
Citation
Thallinger M, Ersdal HL, Francis F, Yeconia A, Mduma E, Kidanto H, Linde JE, Eilevstjonn J, Gunnes N, Stordal K. Born not breathing: A randomised trial comparing two self-inflating bag-masks during newborn resuscitation in Tanzania. Resuscitation. 2017 Jul;116:66-72. doi: 10.1016/j.resuscitation.2017.04.012. Epub 2017 Apr 17.
Results Reference
derived

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Safer Births - Reducing Perinatal Mortality

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