Safer Births - Reducing Perinatal Mortality

NCT01869582 | Completed DMC

• 1 other identifier: Safer Births
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Fetal Heart Rate Abnormalities; Respiratory Depression; Birth Asphyxia; Neonatal Resuscitation

Keywords

Fetal hypoxia; Birth asphyxia; Neonatal resuscitation

Outcome Measures

Primary Outcomes (1)

• Perinatal Mortality

  Death during or shortly following birth

  From start of labour to 7 days postpartum

Study Arms (4)

Doppler, Fetal heart rate

EXPERIMENTAL

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

Device: Doppler, Fetal heart rate

Fetoscope, Fetal heart rate

EXPERIMENTAL

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

Upright Resuscitator, Resuscitation

EXPERIMENTAL

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

Device: Upright Resuscitator, Resuscitation

Standard Resuscitator, Resuscitation

EXPERIMENTAL

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

Interventions

Fetoscope, Fetal heart rate DEVICE

Also known as: Pinard fetoscope

Fetoscope, Fetal heart rate

Upright Resuscitator, Resuscitation DEVICE

Also known as: Laerdal Upright Resuscitator

Upright Resuscitator, Resuscitation

Doppler, Fetal heart rate DEVICE

Also known as: FreePlay Doppler Ultrasound

Doppler, Fetal heart rate

Standard Resuscitator, Resuscitation DEVICE

Also known as: Laerdal Neonatal Resuscitator

Standard Resuscitator, Resuscitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Randomizing fetal heart rate assessment: Placenta abruption/praevia, Ruptured uterus, Morbid Obesity

Sponsors & Collaborators

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

Study Sites (2)

Haydom Lutheran Hospital, Research Institute

Haydom, Manyara Region, 9041, Tanzania

Location

Muhimbili National Hospital

Dar es Salaam, 65439, Tanzania

Location

Related Publications (2)

• 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.

  PMID: 29728142 DERIVED

• 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.

  PMID: 28427883 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Asphyxia Neonatorum; Fetal Hypoxia

Interventions

Fetoscopes; Resuscitation; Echocardiography, Doppler

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment; Emergency Treatment; Therapeutics; Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Ultrasonography, Doppler; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: June 5, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 12, 2020

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

TA (2)