ClinicalTrials.gg
Status unknownNCT05837559Updated May 1, 2023

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

An interventional study of Korle-Bu Modified WHO Partograph for Uncomplicated Labour in Labor Complication, sponsored by University of Ghana Medical School. Status unknown at 1 site in Ghana. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-01.

Sponsored by University of Ghana Medical School · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2022, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Sex
Female
01

Study 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.

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:

  1. Determine provider's 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 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.

02

Conditions studied

  • Labor Complication
03

In context

Obstetric Labor Complications

88 studies on the registry are indexed under Obstetric Labor Complications; 24 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 159 across 63 interventional studies indexed under Obstetric Labor Complications.

Browse Obstetric Labor Complications studies →

Lead sponsor

University of Ghana Medical School is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to vaginal delivery NB: Uncomplicated pregnancy- absence of chronic medical conditions and obstetric conditions such IUGR, congenital anomalies

Exclusion criteria

Exclusion Criteria:

  • Women in advanced labour ( cervical dilation 6 or more)I
  • Induced labour
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Active comparator
    Traditional WHO Partograph for Uncomplicated Labour

    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.

    Other: Korle-Bu Modified WHO Partograph for Uncomplicated Labour

  • Experimental
    Korle-Bu Modified WHO Partograph for Uncomplicated Labour

    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.

    Other: Korle-Bu Modified WHO Partograph for Uncomplicated Labour

Interventions

  • OtherKorle-Bu Modified WHO Partograph for Uncomplicated Labour

    Monitoring of labour using the Korle-Bu Modified WHO Partograph for Uncomplicated Labour

06

What researchers measure

Primary outcomes

  1. Duration of first stage of Labour

    Time of active labour to delivery

    Time frame: 8 hours

  2. 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

    Time frame: one week

  3. consistency of use of the partograph

    Percentage of partographs that are completely and appropriately filled

    Time frame: Through study completion. An average of one year

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 13207246 ↗
  • 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. PubMed 23146139 ↗

Individual participant data

Plan to share: Yes — Deidentified data

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: December, 2023 and for a year

Access criteria: Upon reasonable request

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2022 (actual). Primary completion is estimated for Apr 2023, 15 months after the start.

Of 27 interventional studies with no phase under Obstetric Labor Complications, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 51. This study's planned 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2023
First posted
May 1, 2023
StartActual
Jan 1, 2022
Primary completionEst.
Apr 30, 2023
CompletionEst.
Apr 30, 2023
Last update
May 1, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05837559
Lead sponsor
University of Ghana Medical School
Responsible party
Sponsor
First posted
May 1, 2023
Start date
Jan 1, 2022
Primary completion
Apr 30, 2023 (estimated)
Completion
Apr 30, 2023 (estimated)
Last update
May 1, 2023

Study contacts

Kareem Mumuni, MD,MPH,FWACS
Contact
mumunikareem@yaoo.co.uk
+233244671595
Kwaku Asah-Opoku, MD,MPH,FWACS
Contact
kasah-opoku@ug.edu.gh
+233242048236
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
Kwaku Asah-Opoku, MD,MPH,FWACS
principal investigator · University of Ghana Medical School
Michael Y Ntumy, MD,FWACS
principal investigator · University of Ghana Medical School
Theodor K Boafor, MD, FWACS
principal investigator · University of Ghana Medical School
Kwame Adu-Bonsaffoh, MD, FWACS
principal investigator · University of Ghana Medical School
Mercy A Nuamah, md,PhD
principal investigator · Family Health Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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