Fetal Heart Rate AbnormalitiesNCT01869582
Safer Births - Reducing Perinatal Mortality
A study testing Fetoscope, Fetal heart rate, Upright Resuscitator, Resuscitation and Doppler, Fetal heart rate in people with Fetal Heart Rate Abnormalities and Respiratory Depression, run by Helse Stavanger HF at 2 sites in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fetal Heart Rate Abnormalities, Respiratory Depression, Birth Asphyxia
- What is being tested?
- Fetoscope, Fetal heart rate, Upright Resuscitator, Resuscitation and Doppler, Fetal heart rate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 2 sitesTanzania
- Study dates
- Mar 2013to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Randomizing fetal heart rate assessment: Placenta abruption/praevia, Ruptured uterus, Morbid Obesity
Trial locations and contacts
2 sites in 1 country.
Tanzania2 sites
Muhimbili National Hospital
Dar es Salaam, 65439
Haydom Lutheran Hospital, Research Institute
Haydom, Manyara Region, 9041
About this study
Official title: 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.
- Conditions
- Fetal Heart Rate Abnormalities, Respiratory Depression, Birth Asphyxia, Neonatal Resuscitation
- Being tested
- Fetoscope, Fetal heart rate, Upright Resuscitator, Resuscitation, Doppler, Fetal heart rate, Standard Resuscitator, Resuscitation
- Keywords
- Fetal hypoxia, Birth asphyxia, Neonatal resuscitation
- Medical subject headings
- Respiratory Insufficiency, Asphyxia Neonatorum, Fetal Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetoscope, Fetal heart rateDevice
Also called Pinard fetoscope
Upright Resuscitator, ResuscitationDevice
Also called Laerdal Upright Resuscitator
Doppler, Fetal heart rateDevice
Also called FreePlay Doppler Ultrasound
Standard Resuscitator, ResuscitationDevice
Also called Laerdal Neonatal Resuscitator
| Study group | Role | What they receive |
|---|---|---|
| Doppler, Fetal heart rate | Experimental | Eligible women in labour randomized to intermittent fetal heart rate assessments using a wind-up, hand-held Doppler Receives: 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 Receives: Device: Fetoscope, Fetal heart rate |
| Upright Resuscitator, Resuscitation | Experimental | Non-breathing newborn infants in need of positive pressure ventilation randomized to an Upright Resuscitator Receives: 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 Receives: Device: Standard Resuscitator, Resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal Mortality
Death during or shortly following birth
Measured: From start of labour to 7 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fetal Heart Rate AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- 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
- Responsible party
- Sponsor
- Investigators
- Hege L Ersdal, MD, PhD, Principal investigator, Helse Stavanger HFHussein L Kidanto, MD, PhD, Principal investigator, Muhimbili National HospitalEstomih R Mduma, Manager, Principal investigator, Haydom Lutheran Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869582
- Sponsor's protocol ID
- Safer Births
- Status last verified
- May 2017
- First submitted
- 24 May 2013
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29728142Thallinger 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.
PubMed 28427883
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safer Births - New Knowledge and Innovations to Decrease Perinatal Mortality and Morbidity Worldwide
- ClinicalTrials.gov ID
- NCT01869582
- Acronym / sponsor ID
- Safer Births
- Conditions
- Fetal Heart Rate Abnormalities, Respiratory Depression, Birth Asphyxia, Neonatal Resuscitation
- Keywords
- Fetal hypoxia, Birth asphyxia, Neonatal resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- 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
- Study start
- Mar 2013 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Doppler, Fetal heart rate | Experimental | Device: Doppler, Fetal heart rateEligible women in labour randomized to intermittent fetal heart rate assessments using a wind-up, hand-held Doppler |
| Fetoscope, Fetal heart rate | Experimental | Device: Fetoscope, Fetal heart rateEligible women in labour randomized to intermittent fetal heart rate assessments using a Pinard fetoscope, which is the current standard management |
| Upright Resuscitator, Resuscitation | Experimental | Device: Upright Resuscitator, ResuscitationNon-breathing newborn infants in need of positive pressure ventilation randomized to an Upright Resuscitator |
| Standard Resuscitator, Resuscitation | Experimental | Device: Standard Resuscitator, ResuscitationNon-breathing newborn infants in need of positive pressure ventilation randomized to a standard horizontal Resuscitator, which is the current standard management |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Randomizing fetal heart rate assessment: Placenta abruption/praevia, Ruptured uterus, Morbid Obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetoscope, Fetal heart rateAlso: Pinard fetoscope | Device | Fetoscope, Fetal heart rate |
| Upright Resuscitator, ResuscitationAlso: Laerdal Upright Resuscitator | Device | Upright Resuscitator, Resuscitation |
| Doppler, Fetal heart rateAlso: FreePlay Doppler Ultrasound | Device | Doppler, Fetal heart rate |
| Standard Resuscitator, ResuscitationAlso: Laerdal Neonatal Resuscitator | Device | Standard Resuscitator, Resuscitation |
Primary outcome
Perinatal Mortality
Time frame: From start of labour to 7 days postpartum
Death during or shortly following birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 29728142Mdoe 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.
- Derived from this study: PubMed 28427883Thallinger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hege L Ersdal, MD, PhD principal investigator
Helse Stavanger HF
Hussein L Kidanto, MD, PhD principal investigator
Muhimbili National Hospital
Estomih R Mduma, Manager principal investigator
Haydom Lutheran Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetoscope, Fetal heart rate, Upright Resuscitator, Resuscitation and Doppler, Fetal heart rate in people with Fetal Heart Rate Abnormalities and Respiratory Depression, run by Helse Stavanger HF at 2 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal Mortality (time frame: From start of labour to 7 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01869582, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.