Labor ComplicationNCT05837559
Traditional WHO Partograph and Korle-Bu Modified WHO Partograph for Uncomplicated Labour
A study testing Korle-Bu Modified WHO Partograph for Uncomplicated Labour in people with Labor Complication, run by University of Ghana Medical School at 1 site in Ghana.
Trial summary
Brief Background: The partograph is a graphical representation of the events in the first stage of labour. It is an instrument used in monitoring the well being of both the pregnant woman and her fetus (es) as they go through the first stage of labour. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Complication
- What is being tested?
- Korle-Bu Modified WHO Partograph for Uncomplicated Labour
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteGhana
- Study dates
- 1 Jan 2022to 30 Apr 2023
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women of parity 0-4 with uncomplicated singleton pregnancy admitted at the maternity wards with live fetus in cephalic presentation at term without contraindication to vaginal delivery NB: Uncomplicated pregnancy- absence of chronic medical conditions and obstetric conditions such IUGR, congenital anomalies
Who cannot join
- Women in advanced labour ( cervical dilation 6 or more)I
- Induced labour
Trial locations and contacts
1 site in 1 country.
Ghana1 site, 1 recruiting
- Recruiting
Korle-Bu Teaching Hospital
Accra
Kareem Mumuni, MD,MPH,FWACS, +233244671595, mumunikareem@yahoo.co.uk
Kwaku Asah-Opoku, MD,MPH,FWACS, +233242048236, kasah-opoku@ug.edu.gh
About this study
Official title: Randomized Study of the Traditional WHO Partograph and Korle-Bu Modified WHO Partograph for Uncomplicated Labour
Brief Background:
The partograph is a graphical representation of the events in the first stage of labour. It is an instrument used in monitoring the well being of both the pregnant woman and her fetus (es) as they go through the first stage of labour.
Read more
Most studies found the completion of a partograph in a client's record as the exception rather than the norm. Even at urban maternity wards as low as 5% completion rates of partograph have been recorded and in more than 60% of deliveries the partographs were completed after the deliveries, indicating it was being utilized only as a record-keeping procedure, not as a monitoring tool. The correct and effective use of the partograph is in itself labour intensive even with the requisite skills, making it unfriendly to use in situations where the delivery rates are high with few skilled attendants
General Aim:
To determine whether the use of a Korle-Bu modified WHO partograph will result in similar or improved patronization and leading to consistent monitoring of first stage labour and better outcomes compared to the traditional WHO partograph.
Methods: This will be a randomized study of women presenting in labour with uncomplicated pregnancies to the Korle-Bu Teaching and La General hospitals in Accra. 500 labouring women will be monitored with the traditional WHO partograph in one arm and 500 labouring women will be monitored with the Korle-Bu modified WHO partograph. Computer generated cluster randomization with concealment will be used in patient selection and same research assistants ( Residents and Nurses) will be trained to stick to patient specific protocols for labout monitoring. Variables to be collected besides sociodemographic and obstetric data will include duration of labour, any interventions and neonatal and maternal outcome.
Expected outcome (Expected results/what you hope to achieve from the study):
It is expected that the Korlebu Teaching Hospital (KBTH) modified WHO partograph will be more user friendly, making it easier for service providers to use as a labor management tool than the traditional WHO partograph as intended, to reduce perinatal complication.
Read the detailed description
Background:
The partograph which is a graphical representation of the events in the first stage of labour is a prospective instrument used in monitoring the well being of both the pregnant woman and her fetus (es) as they go through the first stage of labour. Primarily it is to prevent prolonged labour and its attendant adverse outcomes for both mother and baby.
It provides timely information regarding further intervention in the form of referral to a higher-level facility, labour augmentation, and caesarean section etc. depending upon the resources available. At the same time it facilitates ongoing evaluation of the effects of these interventions. It is also a retrospective guide as to how well or not labour may have been managed. World Health Organization designated management of labour with the Partograph as one of the essential elements of obstetric care at the first referral level.
The correct and effective use of the partograph is in itself labour intensive even with the requisite skills, this makes it unfriendly to use in situations where the delivery rates are high with few skilled attendants.
Problem Statement Worldwide the use of the WHO partograph (Pt) has been very limited especially in low resource centres. Studies have found the completion of a partograph in a client's record was the exception rather than the norm. Even at urban maternity wards as low as 5% completion rates of partograph have been recorded and in more than 60% of deliveries the partographs were completed after the deliveries, indicating it was being utilized only as a record-keeping procedure, not as a monitoring tool. The paucity of use and incorrect use of the partograph could be attributed largely to the fact that it is not simple enough, labour intensive and the minimal staffing at low resources areas. This could result in insufficient monitoring leading to perinatal complication.
Justification/Relevance Decreasing the frequency of examinations and measurements to be made on the partograph for uncomplicated pregnancies and labours will make it more user friendly and making it easier for service providers to use as a labor management tool than the WHO partograph as intended, to reduce perinatal complication. . Findings from this study could justify the use or not of the Korle-Bu modified WHO partograph, which is less labour intensive, as a recommended monitoring tool for uncomplicated labour Hypothesis (if any) Null Hypothesis (Ho) The "Korle-Bu modified" WHO partograph would not lead to a lower proportion of prolonged labour and adverse perinatal outcomes compared to the traditional WHO partograph.
H0: Pm > Pt; H1: Pm ≤ Pt General Objective: To determine whether the use of a Korle-Bu modified WHO partograph will result in similar or improved patronization and better first stage labour outcomes compared to the traditional WHO partograph.
Specific objectives are to:
- Determine provider's preference of the two partographs ( Pt or Pm).
- Determine the detection rates of labour complications (slow progress, fetal distress),
- Determine timing of intervention for labor complications
- Determine perinatal outcomes (Fresh Stillbirths and APGAR Scores among live births)
Study design:
This study will be randomized trial
Variables:
Variables under study will include:
Main outcome variables: Duration of Labour and comparable perinatal results for mothers as well as consistency in usage of partographs for assistants.
Other variables:
Obstetric characteristics: Parity, Previous mode of delivery, gestational age. Labour characteristics: Duration of first stage of labour, augmentation, mode of delivery, APGAR scores, indication for any interventions and any maternal and neonatal complications.
Demographic background variables: Age, level of education, occupation, marital status, religion, height, weight.
Sample size calculation:
Using Epi Info 3.4.3 with the following assumptions;
- 95% CI and a Power of 80%, With a Ratio of 1:1
- Expected freq of prolonged labour with traditional partograph = 5%
- Expected freq of prolonged labour with modified partograph= 10% Minimum Sample size calculated and adjusted by 5% = 498 and rounded up to 500 for each arm.
Sampling method:
Procedure:
Participants shall be recruited into the study using a cluster randomization. With a sample size of 500 a computer generated random clusters of 5 participants per cluster will give100 clusters and within each cluster all participants shall be selected as per the generated random numbers into the arms with concealment. The concealment is to eliminate selection bias by staff into any of the arms.
Patients who report in labour with a cervical dilatation of between 4 cm and 6 cm who have consent to participate in the study prior to active labour ( Less the 4 cm cervical delectation) will be randomized into 2 groups. Group A will be monitored on the traditional or regular partograph ( Pt) and Group B will be monitored on the Korle-Bu modified partograph (Pm) . The same research assistants (residents and midwives ) will be trained to stick to patient specific protocols for labour monitoring. With the Korle-Bu modified partograph, uterine contractions will be assessed every hour (60 minutes), fetal heart will be assessed every 30 minutes and maternal pulse every hour. All other assessments remain as for the traditional partograph.
Data collection techniques and tools:
Data collection techniques:
Quantitative techniques will be employed using interviewer administered structured questionnaire and observations of the recordings on the partograph.
Close-ended questions will be used and questionnaire designed with appropriate modifications based on literature review of similar studies done elsewhere especially other developing countries or within the country
Data collection tools:
Structured questionnaire and filling up the , Korle-Bu modified WHO or Traditional WHO partographs. Labour will be monitored and adverse outcomes would be identified and addressed just as the traditional WHO partograph. The instrument is only a monitoring aid and decision on intervention during labour are individualized and taken by the obstetrician / service provider conducting the labour.
Data quality control:
Data will be carefully checked for completeness and for any inconsistencies for each question. Any incompleteness and or inconsistencies will be sorted out and doubly entered same day as they are collected. This will help ensure accuracy of data. The study results will be monitored quarterly in terms of time and sample size This will be done by the heads of Departments of Obstetrics and Child Health which shall consist of a 4 member team including the heads for review quarterly.
Pretesting of questionnaire:
Pretesting of tools will be done at Mamprobi Polyclinic labour wards and appropriate modifications will be made to address any concerns before final print out of questionnaire.
Training of interviewers (residents or midwives):
Midwives from both centers and some residents from KBTH will be trained in administering the questionnaire and on the use and completion of the two types of partograph. The assistants' performance and consistency in filling the partographs will also be assessed after the study without their prior knowledge.
Data handling:
Data will be stored at a secure place and Pre- coded soft data will be analyzed with SPPS 21 and presented in text, tables and graphs.
Statistical Analysis:
Frequencies and means will be calculated for continuous variables The Chi-square statistic for categorical data and statistical significance will be set at p< 0.05.
Contingency tables and logistic regressions would be used to examine associations
DISSEMINATION OF RESULTS The results from this study will be presented at the Department of Obstetrics and Gynecology, School of Medicine and Dentistry (KBTH), College of Health Science, at local and international conferences and will be submitted for publishing in peer review journals.
- Conditions
- Labor Complication
- Being tested
- Korle-Bu Modified WHO Partograph for Uncomplicated Labour
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korle-Bu Modified WHO Partograph for Uncomplicated LabourOther
Monitoring of labour using the Korle-Bu Modified WHO Partograph for Uncomplicated Labour
| Study group | Role | What they receive |
|---|---|---|
| Traditional WHO Partograph for Uncomplicated Labour | Active comparator | With the Traditional WHO partograph, uterine contractions will be assessed every 30 minutes, fetal heart will be assessed every 30 minutes and maternal pulse 30 minutes, blood pressure is recorded every 4 hourly and temperature is recorded every 2 hourly. Urine output is recorded every time urine is passed. The woman is encouraged to pass urine every 2 hourly in labour and each specimen is tested for protein and ketones. Drugs, IV fluids, Drugs (Oxytocin) are recorded in the space provided. Receives: Other: Korle-Bu Modified WHO Partograph for Uncomplicated Labour |
| Korle-Bu Modified WHO Partograph for Uncomplicated Labour | Experimental | With the Korle-Bu modified partograph, uterine contractions will be assessed every hour (60 minutes), fetal heart will be assessed every 30 minutes and maternal pulse every hour. All other assessments remain as for the traditional partograph. Receives: Other: Korle-Bu Modified WHO Partograph for Uncomplicated Labour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of first stage of Labour
Time of active labour to delivery
Measured: 8 hours
Perinatal results
Apgar scores of babies and admission to NICU. Minimum Apgar score equals 1. Maximum Apgar score equals 10. Higher scores mean better outcome
Measured: one week
consistency of use of the partograph
Percentage of partographs that are completely and appropriately filled
Measured: Through study completion. An average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Jan 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Labor 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ghana Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kareem Mumuni, MD,MPH,FWACS, Principal investigator, University of Ghana Medical SchoolAli Samba, MD, FWACS, Principal investigator, University of Ghana Medical SchoolSamuel A Oppong, MD, FWACS, Principal investigator, University of Ghana Medical SchoolKwaku Asah-Opoku, MD,MPH,FWACS, Principal investigator, University of Ghana Medical SchoolMichael Y Ntumy, MD,FWACS, Principal investigator, University of Ghana Medical SchoolTheodor K Boafor, MD, FWACS, Principal investigator, University of Ghana Medical SchoolKwame Adu-Bonsaffoh, MD, FWACS, Principal investigator, University of Ghana Medical SchoolMercy A Nuamah, md,PhD, Principal investigator, Family Health Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837559
- Sponsor's protocol ID
- CHS-ET/M.2-P5.2/2020-2021
- Status last verified
- Feb 2023
- First submitted
- 26 Jan 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data
Publications
1 Alaudin Md, Runa Bal, Arunangsu De, Parthajit Mandal, M ayoukh Chakraborty. Monitoring of labor with WHO modified partgram- A stutdy report. Njog 2008; 3: 8-11
2 Beenu Kushwah, Alok Pratap Singh, Shipra Singh. "The Partograph: an Essential Yet underutilized Tool". Journal of Evolution of Medical and Dental Sciences 2013; Vol2, Issue 24, June 17; Page: 4373-4379.
5 Kitila SB, Gmariam A, Molla A, Nemera G (2014) Utilization of Partograph during Labour and Birth Outcomes at Jimma University. J Preg Child Health 1: 101. doi:10.4172/jpch.1000101
6 Mugerwa, KY and Others (2008) Regional Centre for Quality of Health Care. African Midwives Research Network. East Africa. Kenya.
FRIEDMAN E. The graphic analysis of labor. Am J Obstet Gynecol. 1954 Dec;68(6):1568-75. doi: 10.1016/0002-9378(54)90311-7. No abstract available.
PubMed 13207246Gans-Lartey F, O'Brien BA, Gyekye FO, Schopflocher D. The relationship between the use of the partograph and birth outcomes at Korle-Bu teaching hospital. Midwifery. 2013 May;29(5):461-7. doi: 10.1016/j.midw.2012.03.002. Epub 2012 Nov 9.
PubMed 23146139
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of the Traditional WHO Partograph and Korle-Bu Modified WHO Partograph for Uncomplicated Labour
- ClinicalTrials.gov ID
- NCT05837559
- Acronym / sponsor ID
- CHS-ET/M.2-P5.2/2020-2021
- Conditions
- Labor Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Ghana Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 1 May 2023 (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.
Brief Background:
The partograph is a graphical representation of the events in the first stage of labour. It is an instrument used in monitoring the well being of both the pregnant woman and her fetus (es) as they go through the first stage of labour.
Most studies found the completion of a partograph in a client's record as the exception rather than the norm. Even at urban maternity wards as low as 5% completion rates of partograph have been recorded and in more than 60% of deliveries the partographs were completed after the deliveries, indicating it was being utilized only as a record-keeping procedure, not as a monitoring tool. The correct and effective use of the partograph is in itself labour intensive even with the requisite skills, making it unfriendly to use in situations where the delivery rates are high with few skilled attendants
General Aim:
To determine whether the use of a Korle-Bu modified WHO partograph will result in similar or improved patronization and leading to consistent monitoring of first stage labour and better outcomes compared to the traditional WHO partograph.
Methods: This will be a randomized study of women presenting in labour with uncomplicated pregnancies to the Korle-Bu Teaching and La General hospitals in Accra. 500 labouring women will be monitored with the traditional WHO partograph in one arm and 500 labouring women will be monitored with the Korle-Bu modified WHO partograph. Computer generated cluster randomization with concealment will be used in patient selection and same research assistants ( Residents and Nurses) will be trained to stick to patient specific protocols for labout monitoring. Variables to be collected besides sociodemographic and obstetric data will include duration of labour, any interventions and neonatal and maternal outcome.
Expected outcome (Expected results/what you hope to achieve from the study):
It is expected that the Korlebu Teaching Hospital (KBTH) modified WHO partograph will be more user friendly, making it easier for service providers to use as a labor management tool than the traditional WHO partograph as intended, to reduce perinatal complication.
Detailed description
Background:
The partograph which is a graphical representation of the events in the first stage of labour is a prospective instrument used in monitoring the well being of both the pregnant woman and her fetus (es) as they go through the first stage of labour. Primarily it is to prevent prolonged labour and its attendant adverse outcomes for both mother and baby.
It provides timely information regarding further intervention in the form of referral to a higher-level facility, labour augmentation, and caesarean section etc. depending upon the resources available. At the same time it facilitates ongoing evaluation of the effects of these interventions. It is also a retrospective guide as to how well or not labour may have been managed. World Health Organization designated management of labour with the Partograph as one of the essential elements of obstetric care at the first referral level.
The correct and effective use of the partograph is in itself labour intensive even with the requisite skills, this makes it unfriendly to use in situations where the delivery rates are high with few skilled attendants.
Problem Statement Worldwide the use of the WHO partograph (Pt) has been very limited especially in low resource centres. Studies have found the completion of a partograph in a client's record was the exception rather than the norm. Even at urban maternity wards as low as 5% completion rates of partograph have been recorded and in more than 60% of deliveries the partographs were completed after the deliveries, indicating it was being utilized only as a record-keeping procedure, not as a monitoring tool. The paucity of use and incorrect use of the partograph could be attributed largely to the fact that it is not simple enough, labour intensive and the minimal staffing at low resources areas. This could result in insufficient monitoring leading to perinatal complication.
Justification/Relevance Decreasing the frequency of examinations and measurements to be made on the partograph for uncomplicated pregnancies and labours will make it more user friendly and making it easier for service providers to use as a labor management tool than the WHO partograph as intended, to reduce perinatal complication. . Findings from this study could justify the use or not of the Korle-Bu modified WHO partograph, which is less labour intensive, as a recommended monitoring tool for uncomplicated labour Hypothesis (if any) Null Hypothesis (Ho) The "Korle-Bu modified" WHO partograph would not lead to a lower proportion of prolonged labour and adverse perinatal outcomes compared to the traditional WHO partograph.
H0: Pm > Pt; H1: Pm ≤ Pt General Objective: To determine whether the use of a Korle-Bu modified WHO partograph will result in similar or improved patronization and better first stage labour outcomes compared to the traditional WHO partograph.
Specific objectives are to:
- Determine provider's preference of the two partographs ( Pt or Pm).
- Determine the detection rates of labour complications (slow progress, fetal distress),
- Determine timing of intervention for labor complications
- Determine perinatal outcomes (Fresh Stillbirths and APGAR Scores among live births)
Study design:
This study will be randomized trial
Variables:
Variables under study will include:
Main outcome variables: Duration of Labour and comparable perinatal results for mothers as well as consistency in usage of partographs for assistants.
Other variables:
Obstetric characteristics: Parity, Previous mode of delivery, gestational age. Labour characteristics: Duration of first stage of labour, augmentation, mode of delivery, APGAR scores, indication for any interventions and any maternal and neonatal complications.
Demographic background variables: Age, level of education, occupation, marital status, religion, height, weight.
Sample size calculation:
Using Epi Info 3.4.3 with the following assumptions;
- 95% CI and a Power of 80%, With a Ratio of 1:1
- Expected freq of prolonged labour with traditional partograph = 5%
- Expected freq of prolonged labour with modified partograph= 10% Minimum Sample size calculated and adjusted by 5% = 498 and rounded up to 500 for each arm.
Sampling method:
Procedure:
Participants shall be recruited into the study using a cluster randomization. With a sample size of 500 a computer generated random clusters of 5 participants per cluster will give100 clusters and within each cluster all participants shall be selected as per the generated random numbers into the arms with concealment. The concealment is to eliminate selection bias by staff into any of the arms.
Patients who report in labour with a cervical dilatation of between 4 cm and 6 cm who have consent to participate in the study prior to active labour ( Less the 4 cm cervical delectation) will be randomized into 2 groups. Group A will be monitored on the traditional or regular partograph ( Pt) and Group B will be monitored on the Korle-Bu modified partograph (Pm) . The same research assistants (residents and midwives ) will be trained to stick to patient specific protocols for labour monitoring. With the Korle-Bu modified partograph, uterine contractions will be assessed every hour (60 minutes), fetal heart will be assessed every 30 minutes and maternal pulse every hour. All other assessments remain as for the traditional partograph.
Data collection techniques and tools:
Data collection techniques:
Quantitative techniques will be employed using interviewer administered structured questionnaire and observations of the recordings on the partograph.
Close-ended questions will be used and questionnaire designed with appropriate modifications based on literature review of similar studies done elsewhere especially other developing countries or within the country
Data collection tools:
Structured questionnaire and filling up the , Korle-Bu modified WHO or Traditional WHO partographs. Labour will be monitored and adverse outcomes would be identified and addressed just as the traditional WHO partograph. The instrument is only a monitoring aid and decision on intervention during labour are individualized and taken by the obstetrician / service provider conducting the labour.
Data quality control:
Data will be carefully checked for completeness and for any inconsistencies for each question. Any incompleteness and or inconsistencies will be sorted out and doubly entered same day as they are collected. This will help ensure accuracy of data. The study results will be monitored quarterly in terms of time and sample size This will be done by the heads of Departments of Obstetrics and Child Health which shall consist of a 4 member team including the heads for review quarterly.
Pretesting of questionnaire:
Pretesting of tools will be done at Mamprobi Polyclinic labour wards and appropriate modifications will be made to address any concerns before final print out of questionnaire.
Training of interviewers (residents or midwives):
Midwives from both centers and some residents from KBTH will be trained in administering the questionnaire and on the use and completion of the two types of partograph. The assistants' performance and consistency in filling the partographs will also be assessed after the study without their prior knowledge.
Data handling:
Data will be stored at a secure place and Pre- coded soft data will be analyzed with SPPS 21 and presented in text, tables and graphs.
Statistical Analysis:
Frequencies and means will be calculated for continuous variables The Chi-square statistic for categorical data and statistical significance will be set at p< 0.05.
Contingency tables and logistic regressions would be used to examine associations
DISSEMINATION OF RESULTS The results from this study will be presented at the Department of Obstetrics and Gynecology, School of Medicine and Dentistry (KBTH), College of Health Science, at local and international conferences and will be submitted for publishing in peer review journals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional WHO Partograph for Uncomplicated Labour | Active comparator | Other: Korle-Bu Modified WHO Partograph for Uncomplicated LabourWith the Traditional WHO partograph, uterine contractions will be assessed every 30 minutes, fetal heart will be assessed every 30 minutes and maternal pulse 30 minutes, blood pressure is recorded every 4 hourly and temperature is recorded every 2 hourly. Urine output is recorded every time urine is passed. The woman is encouraged to pass urine every 2 hourly in labour and each specimen is tested for protein and ketones. Drugs, IV fluids, Drugs (Oxytocin) are recorded in the space provided. |
| Korle-Bu Modified WHO Partograph for Uncomplicated Labour | Experimental | Other: Korle-Bu Modified WHO Partograph for Uncomplicated LabourWith the Korle-Bu modified partograph, uterine contractions will be assessed every hour (60 minutes), fetal heart will be assessed every 30 minutes and maternal pulse every hour. All other assessments remain as for the traditional partograph. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women of parity 0-4 with uncomplicated singleton pregnancy admitted at the maternity wards with live fetus in cephalic presentation at term without contraindication to vaginal delivery NB: Uncomplicated pregnancy- absence of chronic medical conditions and obstetric conditions such IUGR, congenital anomalies
Key exclusion criteria (2 listed)
- Women in advanced labour ( cervical dilation 6 or more)I
- Induced labour
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 |
|---|---|---|
| Korle-Bu Modified WHO Partograph for Uncomplicated LabourMonitoring of labour using the Korle-Bu Modified WHO Partograph for Uncomplicated Labour | Other | Korle-Bu Modified WHO Partograph for Uncomplicated Labour, Traditional WHO Partograph for Uncomplicated Labour |
Primary outcome
Duration of first stage of Labour
Time frame: 8 hours
Time of active labour to delivery
Perinatal results
Time frame: one week
Apgar scores of babies and admission to NICU. Minimum Apgar score equals 1. Maximum Apgar score equals 10. Higher scores mean better outcome
consistency of use of the partograph
Time frame: Through study completion. An average of one year
Percentage of partographs that are completely and appropriately filled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Background1 Alaudin Md, Runa Bal, Arunangsu De, Parthajit Mandal, M ayoukh Chakraborty. Monitoring of labor with WHO modified partgram- A stutdy report. Njog 2008; 3: 8-11
- Background2 Beenu Kushwah, Alok Pratap Singh, Shipra Singh. "The Partograph: an Essential Yet underutilized Tool". Journal of Evolution of Medical and Dental Sciences 2013; Vol2, Issue 24, June 17; Page: 4373-4379.
- Background5 Kitila SB, Gmariam A, Molla A, Nemera G (2014) Utilization of Partograph during Labour and Birth Outcomes at Jimma University. J Preg Child Health 1: 101. doi:10.4172/jpch.1000101
- Background6 Mugerwa, KY and Others (2008) Regional Centre for Quality of Health Care. African Midwives Research Network. East Africa. Kenya.
- Results publication: PubMed 13207246FRIEDMAN E. The graphic analysis of labor. Am J Obstet Gynecol. 1954 Dec;68(6):1568-75. doi: 10.1016/0002-9378(54)90311-7. No abstract available.
- Results publication: PubMed 23146139Gans-Lartey F, O'Brien BA, Gyekye FO, Schopflocher D. The relationship between the use of the partograph and birth outcomes at Korle-Bu teaching hospital. Midwifery. 2013 May;29(5):461-7. doi: 10.1016/j.midw.2012.03.002. Epub 2012 Nov 9.
- Individual participant dataSharing planned: Yes. Deidentified data
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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.
Kareem Mumuni, MD,MPH,FWACS principal investigator
University of Ghana Medical School
Ali Samba, MD, FWACS principal investigator
University of Ghana Medical School
Samuel A Oppong, MD, FWACS principal investigator
University of Ghana Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Korle-Bu Modified WHO Partograph for Uncomplicated Labour in people with Labor Complication, run by University of Ghana Medical School at 1 site in Ghana.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 May 2023. 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 Ghana. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kareem Mumuni, MD,MPH,FWACS (+233244671595, mumunikareem@yaoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of first stage of Labour (time frame: 8 hours). The study lists 3 primary outcomes in all. 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 NCT05837559, which also lists 6 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 1 May 2023.