StillbirthNCT02273037
Intermittent Auscultation Using Handheld Doppler: a Randomized Controlled Trial Comparing Perinatal Outcomes in Uganda
A study testing Fetal heart rate Doppler and Partograph in people with Stillbirth and Neonatal Death, run by The Hospital for Sick Children at 2 sites in 2 countries.
Trial summary
A novel handheld Doppler has been developed which is rugged and is powered only by a hand crank. This study aims to test the use of this Doppler versus the Pinard horn to monitor the fetal heart rate in labour in a hospital setting in Uganda. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stillbirth, Neonatal Death
- What is being tested?
- Fetal heart rate Doppler and Partograph
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,987 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All mothers presenting to the labour wards in labour with a singleton pregnancy above 37 completed weeks of gestation, and cephalic presentation
- All mothers admitted to the labour ward for monitoring of active phase of labour with a live intrauterine fetus
Who cannot join
- Mothers admitted to the labour wards with a pregnancy gestation age below 37 weeks
- Mothers admitted with a diagnosis of intra uterine fetal death
- Mothers presenting in second stage of labour
- Mothers with a high risk pregnancy eg pre eclampsia, ante partum hemorrhage
- Mothers being admitted for an elective caesarean section
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The Fetal Heart Monitor Project - Human Energy to Save Lives: Intermittent Auscultation Using Handheld Doppler: a Randomized Controlled Trial Comparing Perinatal Outcomes in Uganda
A novel handheld Doppler has been developed which is rugged and is powered only by a hand crank. This study aims to test the use of this Doppler versus the Pinard horn to monitor the fetal heart rate in labour in a hospital setting in Uganda. The investigators propose that with its ease of use, both for the woman and midwife, midwives using the Doppler will identify more babies in need of prompt delivery and the risk of stillbirth and neonatal mortality will decline. In the research study, the investigators will compare the risk of stillbirths and neonatal mortality in two randomized groups of labouring women.
The second part of the study consists of an audit of the documentation in labour by midwives. The partograph is an uncomplicated, low cost form on which observations during labour are documented. It includes three sections of information: fetal condition, maternal condition and labour progress. Although the use of a partograph during labour is strongly recommended by the WHO, there are limited published systematic evaluations of the correct use of the tool. The investigators aim to use this randomized trial design to assess rates of intrapartum stillbirth and neonatal mortality in the first 24 hours after delivery, and assess the quality of partographs comparing two groups.
This trial will provide insights on the potential benefits of using handheld Doppler devices for intrapartum monitoring, and the audit of partograph quality will provide insights to improve care during labour. This study hypothesizes that the quality of partograph completion and of fetal heart rate monitoring may systematically differ between the Doppler and Pinard groups.
Read the detailed description
- Objectives:
- To evaluate the intervention of a wind-up, handheld Doppler fetal heart rate monitor (Doppler) and to identify implementation challenges;
- To identify process issues and the impact of the Doppler on rates of intrapartum stillbirth and neonatal deaths within 24 hours, in comparison to use of the Pinard horn (current practice);
- To assess the quality of partographs using a standardized scoring system to audit overall completion and quality, and fetal heart rate monitoring specifically; we will compare the audit results between partographs where monitoring was done with the Pinard horn versus the Doppler. The hypothesis being that the quality of partograph completion and of fetal heart rate monitoring may systematically differ between these two groups;
- To build the research capacity of Ugandan midwives by facilitating their participation in this research study.
- Study design Equal randomization clinical trial to compare Pinard horn (current practice) versus Doppler (intervention) to monitor the fetal heart in labour.
- Characteristics of the study population
- Number of participants Based on the results of a randomized controlled trial in urban Zimbabwe in 1994 [Mahomed, BMJ], the investigators hypothesize that use of a handheld Doppler fetal heart monitor will reduce the rate of intrapartum stillbirth by at least 30% compared to monitoring fetal heart rate with a Pinard horn. With 80% power to detect at least a 30% reduction in stillbirths with 95% confidence, 840 labouring women would need to be enrolled in each of the two comparison groups. Adding 20% to allow for losses to follow-up and statistical adjustments/stratification, 1008 labouring women are required for each comparison group.
- Location of the research The study will be conducted in the San Raphael of St Francis Hospital Nsambya Hospital, in Uganda. This is a general hospital and maternity located in the peri-urban region of Kampala City. It is a private not-for-profit institution with 7,500 annual deliveries. In addition, it offers training for residents, intern doctors, nurses, midwives and technicians.
- Data analysis The investigators will review the partograph and record their findings on a tool developed for this purpose. The data that will be recorded will be of statistical nature but at the bottom of each Partograph Assessment Tool is space for qualitative comments from the reviewer. Besides date of birth and the patient file identity number no data will be recorded which can reveal the identity of the patient. This is to ensure patient privacy and confidentiality of the data, without losing the possibility to retrieve the file from medical records if needed. After recording the data on a hard copy in the hospital, the data will be entered twice into the statistical package before analysis. The information that this will give will be descriptively analysed. The proportion and incidence risk rate of participants who experience each fetal outcome under study and the mean partograph scores will be compared between the intervention and control groups.
- Conditions
- Stillbirth, Neonatal Death
- Being tested
- Fetal heart rate Doppler, Partograph
- Keywords
- Labour, Birth asphyxia, Fetal Heart Rate Monitor, Doppler Fetal Heart Rate Monitor, Pinard Horn, Pediatrics, Uganda
- Medical subject headings
- Stillbirth, Perinatal Death, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal heart rate DopplerDevice
Also called wind-up, handheld Doppler, fetal heart rate monitor, Power-free Education Technology Doppler (www.pet.org.za)
A wind-up, handheld fetal heart rate monitor Doppler developed by Power-free Education Technology Doppler (www.pet.org.za)
PartographProcedure or surgery
Also called Partogram
Graphical documentation of labour progress, and maternal and fetal well-being.
| Study group | Role | What they receive |
|---|---|---|
| Pinard horn | Placebo comparator | Pinard horn (current practice) used to monitor the fetal heart rate in labour in this arm of the study. Receives: Procedure: Partograph |
| Fetal heart rate Doppler | Experimental | Doppler used to monitor the fetal heart rate in labour in this arm of the study. Receives: Device: Fetal heart rate Doppler; Procedure: Partograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stillbirth and Neonatal Death
Compare the incidence of fresh stillbirth and neonatal death (within 24h of age) in the Pinard group (current practice) and the Doppler group (study intervention).
Measured: 0-24hour of delivery
Quality of Partograms
To assess the quality of partographs using a standardized scoring system to audit overall completion and quality, and fetal heart rate monitoring specifically. The investigators will compare the audit results between partographs in the Pinard and Doppler group.
Measured: in labour
Secondary outcomes (2)
Identification of Abnormal Fetal Heart Rate
Compare the incidence of identification of abnormal fetal heart rate in labour in the Pinard and Doppler group.
Measured: In labour
Cesarean Delivery (Includes Cesarean Delivery/Intra-uterine Resuscitation/Assisted Delivery)
Compare the proportion of cesarean delivery between the Pinard and Doppler group.
(Includes Cesarean Delivery/Intra-uterine Resuscitation/Assisted delivery)
Measured: Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StillbirthStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,987 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Bassani, The Hospital for Sick Children
- Investigators
- Diego Bassani, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273037
- Sponsor's protocol ID
- 1000031587
- Status last verified
- Aug 2018
- First submitted
- 14 Apr 2014
- Last updated
- 23 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fetal Heart Monitor Project - Human Energy to Save Lives: Intermittent Auscultation Using Handheld Doppler: a Randomized Controlled Trial Comparing Perinatal Outcomes in Uganda
- ClinicalTrials.gov ID
- NCT02273037
- Acronym / sponsor ID
- 1000031587
- Conditions
- Stillbirth, Neonatal Death
- Keywords
- Labour, Birth asphyxia, Fetal Heart Rate Monitor, Doppler Fetal Heart Rate Monitor, Pinard Horn, Pediatrics, Uganda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,987 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Posted 23 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A novel handheld Doppler has been developed which is rugged and is powered only by a hand crank. This study aims to test the use of this Doppler versus the Pinard horn to monitor the fetal heart rate in labour in a hospital setting in Uganda. The investigators propose that with its ease of use, both for the woman and midwife, midwives using the Doppler will identify more babies in need of prompt delivery and the risk of stillbirth and neonatal mortality will decline. In the research study, the investigators will compare the risk of stillbirths and neonatal mortality in two randomized groups of labouring women.
The second part of the study consists of an audit of the documentation in labour by midwives. The partograph is an uncomplicated, low cost form on which observations during labour are documented. It includes three sections of information: fetal condition, maternal condition and labour progress. Although the use of a partograph during labour is strongly recommended by the WHO, there are limited published systematic evaluations of the correct use of the tool. The investigators aim to use this randomized trial design to assess rates of intrapartum stillbirth and neonatal mortality in the first 24 hours after delivery, and assess the quality of partographs comparing two groups.
This trial will provide insights on the potential benefits of using handheld Doppler devices for intrapartum monitoring, and the audit of partograph quality will provide insights to improve care during labour. This study hypothesizes that the quality of partograph completion and of fetal heart rate monitoring may systematically differ between the Doppler and Pinard groups.
Detailed description
- Objectives:
- To evaluate the intervention of a wind-up, handheld Doppler fetal heart rate monitor (Doppler) and to identify implementation challenges;
- To identify process issues and the impact of the Doppler on rates of intrapartum stillbirth and neonatal deaths within 24 hours, in comparison to use of the Pinard horn (current practice);
- To assess the quality of partographs using a standardized scoring system to audit overall completion and quality, and fetal heart rate monitoring specifically; we will compare the audit results between partographs where monitoring was done with the Pinard horn versus the Doppler. The hypothesis being that the quality of partograph completion and of fetal heart rate monitoring may systematically differ between these two groups;
- To build the research capacity of Ugandan midwives by facilitating their participation in this research study.
- Study design Equal randomization clinical trial to compare Pinard horn (current practice) versus Doppler (intervention) to monitor the fetal heart in labour.
- Characteristics of the study population
- Number of participants Based on the results of a randomized controlled trial in urban Zimbabwe in 1994 [Mahomed, BMJ], the investigators hypothesize that use of a handheld Doppler fetal heart monitor will reduce the rate of intrapartum stillbirth by at least 30% compared to monitoring fetal heart rate with a Pinard horn. With 80% power to detect at least a 30% reduction in stillbirths with 95% confidence, 840 labouring women would need to be enrolled in each of the two comparison groups. Adding 20% to allow for losses to follow-up and statistical adjustments/stratification, 1008 labouring women are required for each comparison group.
- Location of the research The study will be conducted in the San Raphael of St Francis Hospital Nsambya Hospital, in Uganda. This is a general hospital and maternity located in the peri-urban region of Kampala City. It is a private not-for-profit institution with 7,500 annual deliveries. In addition, it offers training for residents, intern doctors, nurses, midwives and technicians.
- Data analysis The investigators will review the partograph and record their findings on a tool developed for this purpose. The data that will be recorded will be of statistical nature but at the bottom of each Partograph Assessment Tool is space for qualitative comments from the reviewer. Besides date of birth and the patient file identity number no data will be recorded which can reveal the identity of the patient. This is to ensure patient privacy and confidentiality of the data, without losing the possibility to retrieve the file from medical records if needed. After recording the data on a hard copy in the hospital, the data will be entered twice into the statistical package before analysis. The information that this will give will be descriptively analysed. The proportion and incidence risk rate of participants who experience each fetal outcome under study and the mean partograph scores will be compared between the intervention and control groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pinard horn | Placebo comparator | Procedure: PartographPinard horn (current practice) used to monitor the fetal heart rate in labour in this arm of the study. |
| Fetal heart rate Doppler | Experimental | Device: Fetal heart rate Doppler, Procedure: PartographDoppler used to monitor the fetal heart rate in labour in this arm of the study. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All mothers presenting to the labour wards in labour with a singleton pregnancy above 37 completed weeks of gestation, and cephalic presentation
- All mothers admitted to the labour ward for monitoring of active phase of labour with a live intrauterine fetus
Key exclusion criteria (5 listed)
- Mothers admitted to the labour wards with a pregnancy gestation age below 37 weeks
- Mothers admitted with a diagnosis of intra uterine fetal death
- Mothers presenting in second stage of labour
- Mothers with a high risk pregnancy eg pre eclampsia, ante partum hemorrhage
- Mothers being admitted for an elective caesarean section
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 |
|---|---|---|
| Fetal heart rate DopplerAlso: wind-up, handheld Doppler, fetal heart rate monitor, Power-free Education Technology Doppler (www.pet.org.za)A wind-up, handheld fetal heart rate monitor Doppler developed by Power-free Education Technology Doppler (www.pet.org.za) | Device | Fetal heart rate Doppler |
| PartographAlso: PartogramGraphical documentation of labour progress, and maternal and fetal well-being. | Procedure or surgery | Fetal heart rate Doppler, Pinard horn |
Primary outcome
Stillbirth and Neonatal Death
Time frame: 0-24hour of delivery
Compare the incidence of fresh stillbirth and neonatal death (within 24h of age) in the Pinard group (current practice) and the Doppler group (study intervention).
Quality of Partograms
Time frame: in labour
To assess the quality of partographs using a standardized scoring system to audit overall completion and quality, and fetal heart rate monitoring specifically. The investigators will compare the audit results between partographs in the Pinard and Doppler group.
2 secondary outcomes
Identification of Abnormal Fetal Heart Rate
Time frame: In labour
Cesarean Delivery (Includes Cesarean Delivery/Intra-uterine Resuscitation/Assisted Delivery)
Time frame: Birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Diego Bassani, MD principal investigator
The Hospital for Sick Children
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal heart rate Doppler and Partograph in people with Stillbirth and Neonatal Death, run by The Hospital for Sick Children at 2 sites in 2 countries.
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 5 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 23 Aug 2018. 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 Canada, Uganda. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Stillbirth and Neonatal Death (time frame: 0-24hour of delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2018.