Prolonged LaborNCT03509103
Electronic Partograph: A Way of Improving Partograph Use During Labour Monitoring Process in Selected District Hospitals in Bangladesh
A study testing Electronic Partograph in people with Prolonged Labor, run by International Centre for Diarrhoeal Disease Research, Bangladesh.
Trial summary
Background (brief): 1. Burden: Abnormal prolonged labour and its effects are important contributors to maternal and perinatal mortality and morbidity worldwide. Although the partograph has been shown to be an efficacious tool for monitoring labor and identifying women in need of an comprehensive emergency obstetric… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Prolonged Labor
- What is being tested?
- Electronic Partograph
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,012 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2015to 31 Dec 2016
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- women with spontaneous labour in the first stage of labour
- cervical dilatation in between 4-7 centimeters
- singleton pregnancy
- gestation of at least 37 completed weeks
- cephalic presentations
- no additional complications
Who cannot join
- women with ante partum hemorrhage
- breech presentation,
- multiple pregnancy,
- premature labour (before 37 weeks)
- Eclampsia,
- elective caesarean section
- induced labour
About this study
Background (brief):
- Burden: Abnormal prolonged labour and its effects are important contributors to maternal and perinatal mortality and morbidity worldwide. Although the partograph has been shown to be an efficacious tool for monitoring labor and identifying women in need of an comprehensive emergency obstetric intervention, it's appropriate use is questionable throughout the world. Evidence suggests that very few service provider use partograph despite recognizing its usefulness.
- Knowledge gap: In Bangladesh partograph is hardly used by the concern person though its importance and positive outcome is acknowledged at the national level. To introduce a digital partograph Johns Hopkins Program for International Education in Gynecology and Obstetrics (Jhpiego) developed an ePartogram device and WHO created partograph e-Learning tool. Jhpiego is currently testing three ePartogram implementations. However, till today, no data has been collected or analysed for any of these ePartogram models. The WHO e-Learning tool has been distributed to facilities like Kenyatta National Hospital via CD-ROM. In Kenya, a study also being conducted using a digital partograph (partopen) and results are yet to come.
- Relevance: The use of the paper partograph is found to be complex and too much time-consuming for effective use in low-resource settings where there has been inadequate health care staffing. These challenges highlight a need for strengthening providers' skills and/or developing new technologies that are suitable for low-resource countries and promote consistent, correct use of the partograph as well as, a labour monitoring system for the peripheral level health facilities. The benefits of this device are: ease of use, minimal training requirements, improved data quality and capture, and seamless integration into current local practice.
Read more
Objectives: The current study aims-
- To explore the feasibility, acceptability of digital partograph use among health service providers in selected district hospitals in Bangladesh;
- To compare the user rate between paper and digital partograph during labour monitoring process in district hospitals in Bangladesh;
- To compare the outcome of paper and digital partograph use in respect to the birth asphyxia and prolonged labour rate after introducing digital partograph in selected district hospitals in Bangladesh;
- To determine the barriers and facilitating factors of introducing electronic partograph in district hospital in Bangladesh.
Methods: A mixed-method prospective follow-up study with crossover design will be conducted in two DHs. One DH will serve as intervention (electronic partograph) hospital and another as control hospital (paper-based partograph). After applying the crossover design this allocation will be reversed. The total study will be completed within 18 months period. Nurse-midwives posted in obstetric wards will be the study participants. The sample size in each DH will be 506 mothers who will deliver their baby during the study period.
Outcome measures/variables:
- Feasibility and acceptability of digital partograph use will be assessed among health service providers in selected DH in Bangladesh;
- The user rate of digital partograph will be estimated during labour monitoring process in DHs in Bangladesh;
- The birth asphyxia and prolonged labour rate will be estimated after introducing digital partograph in selected DHs in Bangladesh;
- The barriers and facilitating factors of introducing electronic partograph will be determined in DHs in Bangladesh.
Read the detailed description
Study design, site and duration:
A prospective, follow-up crossover study design was used. Two secondary level referral hospitals in Jessore and Kushtia districts were selected as study sites. The selected facilities were similar in terms of infrastructure, human resources, and service delivery scenarios to typical district hospitals and were thus representative of public hospitals in Bangladesh. However, there were a few differences in the number of c-section and stillbirth rates in between two study hospitals. The crossover study design adopted under this study was designed to minimize the impact of this non-similarity on the study outcomes. The same facility was served as its own control at different time point in time. The study was conducted in two phases with an intervening pause period. During the first phase, an electronic partograph was used in Kushtia district hospital and a paper based partograph was used in Jessore district hospital. Both of these hospitals were being crossed to alternate partograph tool after the pause period.
The nurse-midwives from each hospital posted in obstetric wards were the user who observed the calculated deliveries (N=506 for each facility) during the study period. Each participant attended a two-day long training to become acquainted with the respective partograph that they would be utilizing in the first phase of the study. Another training session was also arranged during the pause period. Clinical parameters recorded in the partograph were validated by the project appointed research assistants with midwifery qualifications who observed labor progression and deliveries.
Sample selection:
Sample size calculations were completed on the basis of existing prevalence of partograph use (17.1 %), and delivery outcome data related to paragraph use such as incidence of birth asphyxia (22%) and prolonged labour (7%) . Sample size calculations also took into account the refusal rate (10%) and design effects. Thus to observe the 50% improvement for all three mentioned clinical parameters (increased use of partograph, decreased level of birth asphyxia, and prolonged labour), the number of deliveries that needed to be observed were as follows, 105, 216 and 506 respectively at 80% power and 5% significance level. Thus the final sample size in each district hospital was taken as 506; half of the sample (253) before and the other half (253) after applying the crossover design. Field data collection continued for 12 months and the data collectors tried to capture all deliveries until the required minimum sample size was achieved.
Inclusion criteria Inclusion criteria for the study were women with spontaneous labour in the first stage of labour with cervical dilatation in between 4-7 centimeters, singleton pregnancy, gestation of at least 37 completed weeks, cephalic presentations, and no additional complications.
Exclusion criteria Exclusion criteria for the study were women with ante partum hemorrhage, breech presentation, multiple pregnancies, premature labour (before 37 weeks), eclampsia, elective caesarean section, and induced labour.
Study procedure and data collection:
An expert obstetrician, who was also a study investigator, provided training to the nurses and midwives. The basics for the paper and electronic partographs were essentially the same, so the training methods were not vastly different. For the e-partograph, a junior programmer was available by mobile phone, around-the-clock, to provide any instant trouble shooting or feedback. In addition, the Android Tablet was used for implementing the digital partograph study. Participants were also introduced to varying inconsistencies and errors they might face when utilizing the e-partograph. The research assistants became expert users of the e-partograph and facilitated the usage for the weak users.
e-partograph: The electronic version of the partograph was a state-of-the-art application that is accessed through smart phone or tablet pc or computer device. The application's user interface (UI) is segmented; users will have to concentrate only on a single portion at a time that would lessen the existing complexity of using paper-based partograph.
e-partograph application's user interface in Android programming language for smart tabs, and in ASP.net with C# language for personal computers. The application has options to save the data in local storage and in a remote central database storage concurrently. Local storage contains data for temporarility; the remote server contains the data permanently which makes the partograph information searchable at any time and place. This application allows partograph data to be monitored remotely.
The existing knowledge on how to use the paper and e-partograph was assessed for each participant before the start of the training to understand the skill status of the individuals. The training consisted of two days of intensive hands on training as well as a refresher course that was organized six months after the first training to ensure that participants would not forget the information. In order to measure user rates, rates of birth asphyxia, and prolonged labour, record reviews generated by the partographs were collected and analyzed.
Data Analysis:
Quantitative data was analyzed using SPSS 23 statistical software. The outcome variables were use of the partograph and delivery outcomes (prolonged labour and birth asphyxia). The independent variables covered maternal demographic and obstetric variables along with fetal characteristics as well as partograph type and facility. Partograph was considered done when it was correctly used for labour monitoring among the delivered women who fall under inclusion criteria. Prolonged labour was defined as labour extending more than 12 hours and birth asphyxia was defined as an APGAR score less than 7 on the 5th minute after delivery. Discrete variables were expressed as percentages and presented as frequency tables and cross tabulations. Chi square (χ2) tests were employed to test the association between proportions of respondents and type of partograph. Statistical significance was defined as p-values of <0.05. The data collected between the two groups was analyzed in such a way that a clear comparison could be made between the user rate of different periods (before and after applying the crossover design). Potential confounding factors were adjusted using binary logistic regression.
Ethical Assurance:
The Research Review Committee (RRC) of the International Centre for Diarrheal Disease Research, Bangladesh (icddr, b) approved the technical part of the proposed study. Then the Ethical Review Committee (ERC) of icddr, b who oversees the protection of human rights, approved the study. In addition, informed consent was obtained from the hospital administration, health workers, and the laboring mothers.
- Conditions
- Prolonged Labor
- Being tested
- Electronic Partograph
- Keywords
- Partograpgh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic PartographOther
The electronic version of the partograph was a state-of-the-art application that is accessed through smart phone or tablet pc or computer device. The application's user interface (UI) is segmented; users will have to concentrate only on a single portion at a time that would lessen the existing complexity of using paper-based partograph.
e-partograph application's user interface in Android programming language for smart tabs, and in ASP.net with C# language for personal computers. The application has options to save the data in local storage and in a remote central database storage concurrently. Local storage contains data for temporarility; the remote server contains the data permanently which makes the partograph information searchable at any time and place. This application allows partograph data to be monitored remotely.
| Study group | Role | What they receive |
|---|---|---|
| Electronic partograph | Experimental | The electronic version of the partograph was a state-of-the-art application that is accessed through smart phone or tablet pc or computer device. The application's user interface (UI) is segmented; users will have to concentrate only on a single portion at a time that would lessen the existing complexity of using paper-based partograph.
e-partograph application's user interface in Android programming language for smart tabs, and in ASP.net with C# language for personal computers. The application has options to save the data in local storage and in a remote central database storage concurrently. Local storage contains data for temporarility; the remote server contains the data permanently which makes the partograph information searchable at any time and place. This application allows partograph data to be monitored remotely. Receives: Other: Electronic Partograph |
| Paper Partograph | Active comparator | An standard training on how to use and fill out partograph was conducted Receives: Other: Electronic Partograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
User rate of Electronic Partograph
Increased user rate
Measured: 37 completed gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 Feb 2015
- Primary completion30 Aug 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolonged LaborStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509103
- Sponsor's protocol ID
- PR-14011
- Status last verified
- Apr 2018
- First submitted
- 16 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rahman A, Begum T, Ashraf F, Akhter S, Hoque DME, Ghosh TK, Rahman M, Stekelenburg J, Das SK, Fatima P, Anwar I. Feasibility and effectiveness of electronic vs. paper partograph on improving birth outcomes: A prospective crossover study design. PLoS One. 2019 Oct 7;14(10):e0222314. doi: 10.1371/journal.pone.0222314. eCollection 2019.
PubMed 31589625
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Partograph: A Way of Improving Partograph Use During Labour Monitoring Process in Selected District Hospitals in Bangladesh
- ClinicalTrials.gov ID
- NCT03509103
- Acronym / sponsor ID
- PR-14011
- Conditions
- Prolonged Labor
- Keywords
- Partograpgh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,012 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 26 Apr 2018 (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.
Background (brief):
- Burden: Abnormal prolonged labour and its effects are important contributors to maternal and perinatal mortality and morbidity worldwide. Although the partograph has been shown to be an efficacious tool for monitoring labor and identifying women in need of an comprehensive emergency obstetric intervention, it's appropriate use is questionable throughout the world. Evidence suggests that very few service provider use partograph despite recognizing its usefulness.
- Knowledge gap: In Bangladesh partograph is hardly used by the concern person though its importance and positive outcome is acknowledged at the national level. To introduce a digital partograph Johns Hopkins Program for International Education in Gynecology and Obstetrics (Jhpiego) developed an ePartogram device and WHO created partograph e-Learning tool. Jhpiego is currently testing three ePartogram implementations. However, till today, no data has been collected or analysed for any of these ePartogram models. The WHO e-Learning tool has been distributed to facilities like Kenyatta National Hospital via CD-ROM. In Kenya, a study also being conducted using a digital partograph (partopen) and results are yet to come.
- Relevance: The use of the paper partograph is found to be complex and too much time-consuming for effective use in low-resource settings where there has been inadequate health care staffing. These challenges highlight a need for strengthening providers' skills and/or developing new technologies that are suitable for low-resource countries and promote consistent, correct use of the partograph as well as, a labour monitoring system for the peripheral level health facilities. The benefits of this device are: ease of use, minimal training requirements, improved data quality and capture, and seamless integration into current local practice.
Objectives: The current study aims-
- To explore the feasibility, acceptability of digital partograph use among health service providers in selected district hospitals in Bangladesh;
- To compare the user rate between paper and digital partograph during labour monitoring process in district hospitals in Bangladesh;
- To compare the outcome of paper and digital partograph use in respect to the birth asphyxia and prolonged labour rate after introducing digital partograph in selected district hospitals in Bangladesh;
- To determine the barriers and facilitating factors of introducing electronic partograph in district hospital in Bangladesh.
Methods: A mixed-method prospective follow-up study with crossover design will be conducted in two DHs. One DH will serve as intervention (electronic partograph) hospital and another as control hospital (paper-based partograph). After applying the crossover design this allocation will be reversed. The total study will be completed within 18 months period. Nurse-midwives posted in obstetric wards will be the study participants. The sample size in each DH will be 506 mothers who will deliver their baby during the study period.
Outcome measures/variables:
- Feasibility and acceptability of digital partograph use will be assessed among health service providers in selected DH in Bangladesh;
- The user rate of digital partograph will be estimated during labour monitoring process in DHs in Bangladesh;
- The birth asphyxia and prolonged labour rate will be estimated after introducing digital partograph in selected DHs in Bangladesh;
- The barriers and facilitating factors of introducing electronic partograph will be determined in DHs in Bangladesh.
Detailed description
Study design, site and duration:
A prospective, follow-up crossover study design was used. Two secondary level referral hospitals in Jessore and Kushtia districts were selected as study sites. The selected facilities were similar in terms of infrastructure, human resources, and service delivery scenarios to typical district hospitals and were thus representative of public hospitals in Bangladesh. However, there were a few differences in the number of c-section and stillbirth rates in between two study hospitals. The crossover study design adopted under this study was designed to minimize the impact of this non-similarity on the study outcomes. The same facility was served as its own control at different time point in time. The study was conducted in two phases with an intervening pause period. During the first phase, an electronic partograph was used in Kushtia district hospital and a paper based partograph was used in Jessore district hospital. Both of these hospitals were being crossed to alternate partograph tool after the pause period.
The nurse-midwives from each hospital posted in obstetric wards were the user who observed the calculated deliveries (N=506 for each facility) during the study period. Each participant attended a two-day long training to become acquainted with the respective partograph that they would be utilizing in the first phase of the study. Another training session was also arranged during the pause period. Clinical parameters recorded in the partograph were validated by the project appointed research assistants with midwifery qualifications who observed labor progression and deliveries.
Sample selection:
Sample size calculations were completed on the basis of existing prevalence of partograph use (17.1 %), and delivery outcome data related to paragraph use such as incidence of birth asphyxia (22%) and prolonged labour (7%) . Sample size calculations also took into account the refusal rate (10%) and design effects. Thus to observe the 50% improvement for all three mentioned clinical parameters (increased use of partograph, decreased level of birth asphyxia, and prolonged labour), the number of deliveries that needed to be observed were as follows, 105, 216 and 506 respectively at 80% power and 5% significance level. Thus the final sample size in each district hospital was taken as 506; half of the sample (253) before and the other half (253) after applying the crossover design. Field data collection continued for 12 months and the data collectors tried to capture all deliveries until the required minimum sample size was achieved.
Inclusion criteria Inclusion criteria for the study were women with spontaneous labour in the first stage of labour with cervical dilatation in between 4-7 centimeters, singleton pregnancy, gestation of at least 37 completed weeks, cephalic presentations, and no additional complications.
Exclusion criteria Exclusion criteria for the study were women with ante partum hemorrhage, breech presentation, multiple pregnancies, premature labour (before 37 weeks), eclampsia, elective caesarean section, and induced labour.
Study procedure and data collection:
An expert obstetrician, who was also a study investigator, provided training to the nurses and midwives. The basics for the paper and electronic partographs were essentially the same, so the training methods were not vastly different. For the e-partograph, a junior programmer was available by mobile phone, around-the-clock, to provide any instant trouble shooting or feedback. In addition, the Android Tablet was used for implementing the digital partograph study. Participants were also introduced to varying inconsistencies and errors they might face when utilizing the e-partograph. The research assistants became expert users of the e-partograph and facilitated the usage for the weak users.
e-partograph: The electronic version of the partograph was a state-of-the-art application that is accessed through smart phone or tablet pc or computer device. The application's user interface (UI) is segmented; users will have to concentrate only on a single portion at a time that would lessen the existing complexity of using paper-based partograph.
e-partograph application's user interface in Android programming language for smart tabs, and in ASP.net with C# language for personal computers. The application has options to save the data in local storage and in a remote central database storage concurrently. Local storage contains data for temporarility; the remote server contains the data permanently which makes the partograph information searchable at any time and place. This application allows partograph data to be monitored remotely.
The existing knowledge on how to use the paper and e-partograph was assessed for each participant before the start of the training to understand the skill status of the individuals. The training consisted of two days of intensive hands on training as well as a refresher course that was organized six months after the first training to ensure that participants would not forget the information. In order to measure user rates, rates of birth asphyxia, and prolonged labour, record reviews generated by the partographs were collected and analyzed.
Data Analysis:
Quantitative data was analyzed using SPSS 23 statistical software. The outcome variables were use of the partograph and delivery outcomes (prolonged labour and birth asphyxia). The independent variables covered maternal demographic and obstetric variables along with fetal characteristics as well as partograph type and facility. Partograph was considered done when it was correctly used for labour monitoring among the delivered women who fall under inclusion criteria. Prolonged labour was defined as labour extending more than 12 hours and birth asphyxia was defined as an APGAR score less than 7 on the 5th minute after delivery. Discrete variables were expressed as percentages and presented as frequency tables and cross tabulations. Chi square (χ2) tests were employed to test the association between proportions of respondents and type of partograph. Statistical significance was defined as p-values of <0.05. The data collected between the two groups was analyzed in such a way that a clear comparison could be made between the user rate of different periods (before and after applying the crossover design). Potential confounding factors were adjusted using binary logistic regression.
Ethical Assurance:
The Research Review Committee (RRC) of the International Centre for Diarrheal Disease Research, Bangladesh (icddr, b) approved the technical part of the proposed study. Then the Ethical Review Committee (ERC) of icddr, b who oversees the protection of human rights, approved the study. In addition, informed consent was obtained from the hospital administration, health workers, and the laboring mothers.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic partograph | Experimental | Other: Electronic PartographThe electronic version of the partograph was a state-of-the-art application that is accessed through smart phone or tablet pc or computer device. The application's user interface (UI) is segmented; users will have to concentrate only on a single portion at a time that would lessen the existing complexity of using paper-based partograph. e-partograph application's user interface in Android programming language for smart tabs, and in ASP.net with C# language for personal computers. The application has options to save the data in local storage and in a remote central database storage concurrently. Local storage contains data for temporarility; the remote server contains the data permanently which makes the partograph information searchable at any time and place. This application allows partograph data to be monitored remotely. |
| Paper Partograph | Active comparator | Other: Electronic PartographAn standard training on how to use and fill out partograph was conducted |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- women with spontaneous labour in the first stage of labour
- cervical dilatation in between 4-7 centimeters
- singleton pregnancy
- gestation of at least 37 completed weeks
- cephalic presentations
Key exclusion criteria (7 listed)
- women with ante partum hemorrhage
- breech presentation,
- multiple pregnancy,
- premature labour (before 37 weeks)
- Eclampsia,
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 |
|---|---|---|
| Electronic PartographThe electronic version of the partograph was a state-of-the-art application that is accessed through smart phone or tablet pc or computer device. The application's user interface (UI) is segmented; users will have to concentrate only on a single portion at a time that would lessen the existing complexity of using paper-based partograph. e-partograph application's user interface in Android programming language for smart tabs, and in ASP.net with C# language for personal computers. The application has options to save the data in local storage and in a remote central database storage concurrently. Local storage contains data for temporarility; the remote server contains the data permanently which makes the partograph information searchable at any time and place. This application allows partograph data to be monitored remotely. | Other | Electronic partograph, Paper Partograph |
Primary outcome
User rate of Electronic Partograph
Time frame: 37 completed gestational weeks
Increased user rate
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 11 May 2018.
- Derived from this study: PubMed 31589625Rahman A, Begum T, Ashraf F, Akhter S, Hoque DME, Ghosh TK, Rahman M, Stekelenburg J, Das SK, Fatima P, Anwar I. Feasibility and effectiveness of electronic vs. paper partograph on improving birth outcomes: A prospective crossover study design. PLoS One. 2019 Oct 7;14(10):e0222314. doi: 10.1371/journal.pone.0222314. eCollection 2019.
- Individual participant dataSharing planned: No
Related trials for Prolonged Labor
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Not yet recruiting
Predicting Declines in Attention and Memory During a Prolonged Mental Task
Mental Fatigue, Cognitive Performance
Recruiting
Maternal Maneuvers During Prolonged Labor
Labor Stage, First, Prolonged Labor
Not yet recruitingObservational study
Predictors of Prolonged Mechanical Ventilation in Preterm Infants
Premature Birth, Respiration Failure
RecruitingPhase 4
Prolonged Progesterone to Prevent Preterm Birth From IVF - ET
Preterm Birth
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.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Partograph in people with Prolonged Labor, run by International Centre for Diarrhoeal Disease Research, Bangladesh.
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 6 inclusion and 7 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 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
User rate of Electronic Partograph (time frame: 37 completed gestational weeks). 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 NCT03509103, which also lists 1 linked publication.
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 11 May 2018.