Obstetric ComplicationNCT03856307
Reliability of Simple Sonographic Findings Acquired With Hand-held Apparatuses to Inform Obstetric Diagnosis
An observational study of Obstetric Complication and Vaginal Bleeding, run by Doctors with Africa - CUAMM at 1 site in Sierra Leone.
Trial summary
the study aims to assess the reliability of ultrasound findings measured by hand held ultrasound probes used by operators with variable experience in a low resource hospital. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obstetric Complication, Vaginal Bleeding, Eclampsia Preeclampsia
- What is being tested?
- point of care ultrasound
- How many people
- 300 participants
- Where
- 1 siteSierra Leone
- Study dates
- 1 Mar 2019to 1 Jun 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Vaginal bleeding in early pregnancy:Vaginal bleeding or cramping, with amenorrhea or positive pregnancy test <22 weeks of gestation * Pre-eclampsia:Blood pressure ≥140/90 (at least 2 recordings, 4 hours apart) PLUS any of: proteinuria (at least 2+ on dipstick, headache, generalized oedema, visual disturbance). * APH third trimester: Vaginal bleeding after 22 weeks of pregnancy or in labour before giving birth. May have final diagnosis of abruptio placentae, placenta previa and ruptured uterus. * Prolonged/Obstructed labour: Prolonged latent or active phase, cephalopelvic disproportion, obstructed labor, inadequate uterine activity, prolonged expulsive phase. * High risk pregnancy in ANC defined by hospital protocol
Who may be able to join
- Admitted to the emergency department, outpatient department, in-patient department or antenatal care (ANC) of the PCMH during the study period.
- Fulfills one or more of the five inclusion categories: i.e. vaginal bleeding in early pregnancy, pre-eclampsia, prolonged/obstructed labor, antepartum hemorrhage (APH) and other high risk pregnancies encountered in ANC.
Who cannot join
- Ultrasound examination not feasible, e.g., due to electricity breakdown, or physical absence or unavailability of the trained sonographers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Simple Sonographic Findings Acquired With Hand-held Apparatuses to Inform Obstetric Diagnosis in an Urban Low Resource Setting
the study aims to assess the reliability of ultrasound findings measured by hand held ultrasound probes used by operators with variable experience in a low resource hospital.
Read the detailed description
Rationale: The majority of obstetric emergencies are identified through clinical examination, which cannot be substituted by ultrasound. However, just as a laboratory exam, ultrasonograpy can provide swift point of care information on fetus presentation, viability, placenta position, quantity of amniotic fluid and presence of abdominal fluid to inform the clinical reasoning and therapeutic escalation. Ultrasound literature in low-resource settings has favoured antenatal care (ANC) rather than the emergency setting. Also, hand-held ultrasound machines may not be as performant as traditional machines used by expert operators but to date is still to be tested in a low resource setting.
Objective: to assess the reliability of ultrasound findings measured by hand held ultrasound probes used by operators with variable experience in a low resource hospital.
Hypothesis: There is substantial agreement between simple ultrasound findings identified using hand held ultrasound devices and the reference standard.
Study design: a prospective observational diagnostic accuracy study. Study population: parturients admitted to the Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone.
Sample size: no formal sample size calculation is performed. Based on current rates of admissions to the PCMH we expect to perform obstetrical ultrasound scan in at least 300 patients during a 2-months study period.
Methods: 4 trained physicians (3 naive and 1 intermediate ultrasound users) will perform the ultrasound investigations using the hand held device and complete a structured predefined report form of obstetric ultrasound findings at patient admission or according to clinical indications after admission. These will be compared with the reference standard, i.e. an ultrasound examination performed by a specialist gynecologist/obstetrician using a conventional apparatus in the hospital ultrasound room.
Main study parameters/primary endpoints: The mean diagnostic accuracy among nine ultrasound obstetric findings collected with hand held devices versus the reference standard.
- Conditions
- Obstetric Complication, Vaginal Bleeding, Eclampsia Preeclampsia, Obstructed Labor, Antepartum Hemorrhage
- Being tested
- point of care ultrasound
- Medical subject headings
- Uterine Hemorrhage, Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
point of care ultrasoundDiagnostic test
to evaluate the reliability of simple pre-specified ultrasound findings acquired at the bedside with a hand-held apparatus with regards to five clinical scenarios most commonly encountered in the hospital, i.e. vaginal bleeding in early pregnancy, pre-eclampsia, prolonged/obstructed labor, antepartum hemorrhage (APH) and high risk pregnancies encountered in ANC.
What is being measured
The primary outcome is the main question the study is designed to answer.
composite reliability of simple obstetric ultrasound findings collected by hand held ultrasound devices in a busy urban low resource setting.
the mean aggregated diagnostic accuracy between the ultrasound findings collected via hand held devices as compared to the conventional apparatus.
Measured: From admission to 48 hours later
Secondary outcomes (3)
reliability for each pre-defined ultrasound finding
Detailed diagnostic accuracy for each of the nine ultrasound findings.
Measured: From admission to 48 hours later
variance of the reliability between naïve and intermediate operators.
Inter-observer agreement on ultrasound findings between naïve and intermediate operators.
Measured: From admission to 48 hours later
quality of images acquired with the hand held apparatus.
Mean 'quality of image score' (0-4) for each of the nine ultrasound findings.
Measured: From admission to 48 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Mar 2019
- Primary completion1 Apr 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric ComplicationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Doctors with Africa - CUAMM
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuichi Kodaira, Doctors with Africa - CUAMM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856307
- Sponsor's protocol ID
- 01-2019
- Status last verified
- Jul 2019
- First submitted
- 25 Feb 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Simple Sonographic Findings Acquired With Hand-held Apparatuses to Inform Obstetric Diagnosis in an Urban Low Resource Setting
- ClinicalTrials.gov ID
- NCT03856307
- Acronym / sponsor ID
- 01-2019
- Conditions
- Obstetric Complication, Vaginal Bleeding, Eclampsia Preeclampsia, Obstructed Labor, Antepartum Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Doctors with Africa - CUAMMUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 27 Feb 2019 (actual)
- 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.
the study aims to assess the reliability of ultrasound findings measured by hand held ultrasound probes used by operators with variable experience in a low resource hospital.
Detailed description
Rationale: The majority of obstetric emergencies are identified through clinical examination, which cannot be substituted by ultrasound. However, just as a laboratory exam, ultrasonograpy can provide swift point of care information on fetus presentation, viability, placenta position, quantity of amniotic fluid and presence of abdominal fluid to inform the clinical reasoning and therapeutic escalation. Ultrasound literature in low-resource settings has favoured antenatal care (ANC) rather than the emergency setting. Also, hand-held ultrasound machines may not be as performant as traditional machines used by expert operators but to date is still to be tested in a low resource setting.
Objective: to assess the reliability of ultrasound findings measured by hand held ultrasound probes used by operators with variable experience in a low resource hospital.
Hypothesis: There is substantial agreement between simple ultrasound findings identified using hand held ultrasound devices and the reference standard.
Study design: a prospective observational diagnostic accuracy study. Study population: parturients admitted to the Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone.
Sample size: no formal sample size calculation is performed. Based on current rates of admissions to the PCMH we expect to perform obstetrical ultrasound scan in at least 300 patients during a 2-months study period.
Methods: 4 trained physicians (3 naive and 1 intermediate ultrasound users) will perform the ultrasound investigations using the hand held device and complete a structured predefined report form of obstetric ultrasound findings at patient admission or according to clinical indications after admission. These will be compared with the reference standard, i.e. an ultrasound examination performed by a specialist gynecologist/obstetrician using a conventional apparatus in the hospital ultrasound room.
Main study parameters/primary endpoints: The mean diagnostic accuracy among nine ultrasound obstetric findings collected with hand held devices versus the reference standard.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Vaginal bleeding in early pregnancy:Vaginal bleeding or cramping, with amenorrhea or positive pregnancy test <22 weeks of gestation * Pre-eclampsia:Blood pressure ≥140/90 (at least 2 recordings, 4 hours apart) PLUS any of: proteinuria (at least 2+ on dipstick, headache, generalized oedema, visual disturbance). * APH third trimester: Vaginal bleeding after 22 weeks of pregnancy or in labour before giving birth. May have final diagnosis of abruptio placentae, placenta previa and ruptured uterus. * Prolonged/Obstructed labour: Prolonged latent or active phase, cephalopelvic disproportion, obstructed labor, inadequate uterine activity, prolonged expulsive phase. * High risk pregnancy in ANC defined by hospital protocol
Key inclusion criteria (2 listed)
- Admitted to the emergency department, outpatient department, in-patient department or antenatal care (ANC) of the PCMH during the study period.
- Fulfills one or more of the five inclusion categories: i.e. vaginal bleeding in early pregnancy, pre-eclampsia, prolonged/obstructed labor, antepartum hemorrhage (APH) and other high risk pregnancies encountered in ANC.
Key exclusion criteria (1 listed)
- Ultrasound examination not feasible, e.g., due to electricity breakdown, or physical absence or unavailability of the trained sonographers.
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 |
|---|---|---|
| point of care ultrasoundto evaluate the reliability of simple pre-specified ultrasound findings acquired at the bedside with a hand-held apparatus with regards to five clinical scenarios most commonly encountered in the hospital, i.e. vaginal bleeding in early pregnancy, pre-eclampsia, prolonged/obstructed labor, antepartum hemorrhage (APH) and high risk pregnancies encountered in ANC. | Diagnostic test | – |
Primary outcome
composite reliability of simple obstetric ultrasound findings collected by hand held ultrasound devices in a busy urban low resource setting.
Time frame: From admission to 48 hours later
the mean aggregated diagnostic accuracy between the ultrasound findings collected via hand held devices as compared to the conventional apparatus.
3 secondary outcomes
reliability for each pre-defined ultrasound finding
Time frame: From admission to 48 hours later
variance of the reliability between naïve and intermediate operators.
Time frame: From admission to 48 hours later
quality of images acquired with the hand held apparatus.
Time frame: From admission to 48 hours later
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 24 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Complication and Vaginal Bleeding, run by Doctors with Africa - CUAMM at 1 site in Sierra Leone.
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 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sierra Leone. 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?
composite reliability of simple obstetric ultrasound findings collected by hand held ultrasound devices in a busy urban low resource setting. (time frame: From admission to 48 hours later). 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 24 Jul 2019.