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

NCT05837559 | Unknown

• 1 other identifier: CHS-ET/M.2-P5.2/2020-2021
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Complication

Outcome Measures

Primary Outcomes (3)

• Duration of first stage of Labour

  Time of active labour to delivery

  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

  one week

• consistency of use of the partograph

  Percentage of partographs that are completely and appropriately filled

  Through study completion. An average of one year

Study Arms (2)

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.

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.

Other: Korle-Bu Modified WHO Partograph for Uncomplicated Labour

Interventions

Korle-Bu Modified WHO Partograph for Uncomplicated Labour OTHER

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

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women in advanced labour ( cervical dilation 6 or more)I
• Induced labour

Sponsors & Collaborators

• University of Ghana Medical School: lead

Study Sites (1)

Korle-Bu Teaching Hospital

Accra, Ghana

RECRUITING

Related Publications (6)

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 6 Mugerwa, KY and Others (2008) Regional Centre for Quality of Health Care. African Midwives Research Network. East Africa. Kenya.

  BACKGROUND

• 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.

  PMID: 13207246 RESULT

• 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.

  PMID: 23146139 RESULT

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Kareem Mumuni, MD,MPH,FWACS

  University of Ghana Medical School

  PRINCIPAL INVESTIGATOR

• Ali Samba, MD, FWACS

  University of Ghana Medical School

  PRINCIPAL INVESTIGATOR

• Samuel A Oppong, MD, FWACS

  University of Ghana Medical School

  PRINCIPAL INVESTIGATOR

• Kwaku Asah-Opoku, MD,MPH,FWACS

  University of Ghana Medical School

  PRINCIPAL INVESTIGATOR

• Michael Y Ntumy, MD,FWACS

  University of Ghana Medical School

  PRINCIPAL INVESTIGATOR

• Theodor K Boafor, MD, FWACS

  University of Ghana Medical School

  PRINCIPAL INVESTIGATOR

• Kwame Adu-Bonsaffoh, MD, FWACS

  University of Ghana Medical School

  PRINCIPAL INVESTIGATOR

• Mercy A Nuamah, md,PhD

  Family Health Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kareem Mumuni, MD,MPH,FWACS

CONTACT

+233244671595; mumunikareem@yaoo.co.uk

Kwaku Asah-Opoku, MD,MPH,FWACS

CONTACT

+233242048236; kasah-opoku@ug.edu.gh

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: May 1, 2023
• Study Start: January 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: December, 2023 and for a year
• Access Criteria: Upon reasonable request

Locations

GH (1)