Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05837559
Status:
RECRUITING
Last Update Posted:
2023-05-01
First Post:
2023-01-26
Brief Title:
Traditional WHO Partograph and Korle-Bu Modified WHO Partograph for Uncomplicated Labour
Sponsor:
University of Ghana Medical School
Organization:
University of Ghana Medical School
Study Overview
Official Title:
Randomized Study of the Traditional WHO Partograph and Korle-Bu Modified WHO Partograph for Uncomplicated Labour
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Most studies found the completion of a partograph in a clients 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 resultswhat 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
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 clients 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 resultswhat 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 clients 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
JustificationRelevance 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
1 Determine providers preference of the two partographs Pt or Pm
2 Determine the detection rates of labour complications slow progress fetal distress
3 Determine timing of intervention for labor complications
4 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 343 with the following assumptions
95 CI and a Power of 80 With a Ratio of 11
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 005
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
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 clients 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
JustificationRelevance 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
1 Determine providers preference of the two partographs Pt or Pm
2 Determine the detection rates of labour complications slow progress fetal distress
3 Determine timing of intervention for labor complications
4 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 343 with the following assumptions
95 CI and a Power of 80 With a Ratio of 11
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 005
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None