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Traditional WHO Partograph and Korle-Bu Modified WHO Partograph for Uncomplicated Labour

Primary Purpose

Labor Complication

Status
Recruiting
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
Korle-Bu Modified WHO Partograph for Uncomplicated Labour
Sponsored by
University of Ghana Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Complication

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: • 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 Exclusion Criteria: Women in advanced labour ( cervical dilation 6 or more)I Induced labour

Sites / Locations

  • Korle-Bu Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional WHO Partograph for Uncomplicated Labour

Korle-Bu Modified WHO Partograph for Uncomplicated Labour

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Duration of first stage of Labour
Time of active labour to delivery
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
consistency of use of the partograph
Percentage of partographs that are completely and appropriately filled

Secondary Outcome Measures

Full Information

First Posted
January 26, 2023
Last Updated
April 18, 2023
Sponsor
University of Ghana Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT05837559
Brief Title
Traditional WHO Partograph and Korle-Bu Modified WHO Partograph for Uncomplicated Labour
Official Title
Randomized Study of the Traditional WHO Partograph and Korle-Bu Modified WHO Partograph for Uncomplicated Labour
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ghana Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Complication

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional WHO Partograph for Uncomplicated Labour
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Korle-Bu Modified WHO Partograph for Uncomplicated Labour
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Korle-Bu Modified WHO Partograph for Uncomplicated Labour
Intervention Description
Monitoring of labour using the Korle-Bu Modified WHO Partograph for Uncomplicated Labour
Primary Outcome Measure Information:
Title
Duration of first stage of Labour
Description
Time of active labour to delivery
Time Frame
8 hours
Title
Perinatal results
Description
Apgar scores of babies and admission to NICU. Minimum Apgar score equals 1. Maximum Apgar score equals 10. Higher scores mean better outcome
Time Frame
one week
Title
consistency of use of the partograph
Description
Percentage of partographs that are completely and appropriately filled
Time Frame
Through study completion. An average of one year

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • 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 Exclusion Criteria: Women in advanced labour ( cervical dilation 6 or more)I Induced labour
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kareem Mumuni, MD,MPH,FWACS
Phone
+233244671595
Email
mumunikareem@yaoo.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Kwaku Asah-Opoku, MD,MPH,FWACS
Phone
+233242048236
Email
kasah-opoku@ug.edu.gh
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kareem Mumuni, MD,MPH,FWACS
Organizational Affiliation
University of Ghana Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali Samba, MD, FWACS
Organizational Affiliation
University of Ghana Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel A Oppong, MD, FWACS
Organizational Affiliation
University of Ghana Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kwaku Asah-Opoku, MD,MPH,FWACS
Organizational Affiliation
University of Ghana Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Y Ntumy, MD,FWACS
Organizational Affiliation
University of Ghana Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Theodor K Boafor, MD, FWACS
Organizational Affiliation
University of Ghana Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kwame Adu-Bonsaffoh, MD, FWACS
Organizational Affiliation
University of Ghana Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mercy A Nuamah, md,PhD
Organizational Affiliation
Family Health Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korle-Bu Teaching Hospital
City
Accra
Country
Ghana
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kareem Mumuni, MD,MPH,FWACS
Phone
+233244671595
Email
mumunikareem@yahoo.co.uk
First Name & Middle Initial & Last Name & Degree
Kwaku Asah-Opoku, MD,MPH,FWACS
Phone
+233242048236
Email
kasah-opoku@ug.edu.gh

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data
IPD Sharing Time Frame
December, 2023 and for a year
IPD Sharing Access Criteria
Upon reasonable request
Citations:
Citation
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
Results Reference
background
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
6 Mugerwa, KY and Others (2008) Regional Centre for Quality of Health Care. African Midwives Research Network. East Africa. Kenya.
Results Reference
background
PubMed Identifier
13207246
Citation
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.
Results Reference
result
PubMed Identifier
23146139
Citation
Gans-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.
Results Reference
result

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Traditional WHO Partograph and Korle-Bu Modified WHO Partograph for Uncomplicated Labour

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