Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202308531056545 Date of Approval: 25/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Labour outcomes among low-risk women using WHO next-generation partograph versus WHO composite partograph: A quasi-experimental study
Official scientific title Comparison of Maternal and Newborn outcome among low-risk pregnant women: World health Organization Labor Care guide versus Standard of care; A quasi-experimental study
Brief summary describing the background and objectives of the trial Background: Partogram is an important tool in the management of labor and delivery. Its correct use, has shown to decrease maternal and newborn adverse events including deaths. In Tanzania, composite partograph is used as a standard of care. World Health Organization (WHO) released Labour Care Guide (LCG), a next-generation partograph that emphasizes on woman-centered care. Objective: This study compared maternal and newborn outcomes among low-risk pregnant women who were monitored by using the WHO LCG versus those who were monitored by using the composite partograph.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Monitoring Progress of Labour
Anticipated trial start date 01/09/2021
Actual trial start date 01/09/2021
Anticipated date of last follow up 30/12/2021
Actual Last follow-up date 30/12/2021
Anticipated target sample size (number of participants) 482
Actual target sample size (number of participants) 482
Recruitment status Completed
Publication URL chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://assets.researchsquare.com/files/rs-2603863/v1/781d64d4-f767-499c-a10c-0f8aa0fa9ce6.pdf?c=1679410396
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Labour Care Guide Low-risk women in Labour were monitored by using a new partograph (Labour Care Guide) through Labour up to 24 hours post delivery Low-risk women in Labour were monitored by using a new partograph (Labour Care Guide) through Labour up to 24 hours post delivery Pregnant women in Labour were screened for risk of obstetric complications. Low-risk women in Labour were monitored by using a new partograph (Labour Care Guide) through Labour up to 24 hours post-delivery. This was done at the intervention site. at the control site, low-risk women in Labour were monitored by using a Composite partograph. Then Labour outcomes were compared. 241
Control Group Composite Partograph Women in Labour were monitored by using composite partograph throughout labor up to 24 hours post delivery Women in Labour were monitored by using composite partograph throughout labor up to 24 hours post delivery Pregnant women in Labor were screened for risk of obstetric complications, and low-risk women were monitored by using composite partograph. 241 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Low-risk pregnant women in Labour Pregnant Women in labour with cervical dilatation of more than 8cm Adult: 19 Year-44 Year 20 Year(s) 35 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/05/2021 MUHAS Research and Ethics comitee
Ethics Committee Address
Street address City Postal code Country
9 United Nations Road Upanga West Street P.O.BOX 65001 Dar es salaam Dar es salaam 565 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The following outcomes were compared as depicted in the WHO quality of care framework: mode of delivery, Post-Partum Hemorrhage, labour augmentation, duration of labor, maternal death, Apgar score, admission to Neonatal Intensive Care Unit, and perinatal death. During the time of Labour and delivery
Secondary Outcome The following outcomes were compared as depicted in the WHO quality of care framework: mode of delivery, Post-Partum Hemorrhage, labour augmentation, duration of labor, maternal death, Apgar score, admission to Neonatal Intensive Care Unit, and perinatal death. Throughout Labour and delivery up to 24 hours post delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mnazi Mmoja Hospital Mnazi Mmoja City Centre Dar es salaam 565 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded P.O.BOX 743 DODOMA 3923 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self Sponsored P.O.BOX 743 DODOMA 3923 United Republic of Tanzania Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Phineas F. Sospeter phinsosp@gmail.com +255756791870 Dodoma
City Postal code Country Position/Affiliation
Dodoma 3923 United Republic of Tanzania Ministry of Health Tanzania
Role Name Email Phone Street address
Public Enquiries Fadhlun M. Alwy AlBeity Fadhlundr@gmail.com +255715299560 Dar es salaam
City Postal code Country Position/Affiliation
Dar es salaam 565 United Republic of Tanzania Muhimbili University
Role Name Email Phone Street address
Scientific Enquiries Hussein L Kidanto hkidanto@gmail.com +255784462478 Dar es salaam
City Postal code Country Position/Affiliation
Dar es salaam 565 United Republic of Tanzania Aga Khan University Dar es salaam Tanzania
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Access to Individual Participant Data (IPD) including data set and partograph, will be shared upon request by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Data requests can be submitted starting 2 months after article publication and the data will be made accessible for up to 2 months. Extensions will be considered on a case-by-case basis. For more information or to submit a request, please contact phinsosp@gmail.com Informed Consent Form 12 Months URL
URL Results Available Results Summary Result Posting Date First Journal Publication Date
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://assets.researchsquare.com/files/rs-2603863/v1/781d64d4-f767-499c-a10c-0f8aa0fa9ce6.pdf?c=1679410396 Yes 22/08/2023 21/03/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 22/08/2023 Result - 22/08/2023 Result - 22/08/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://assets.researchsquare.com/files/rs-2603863/v1/781d64d4-f767-499c-a10c-0f8aa0fa9ce6.pdf?c=1679410396
Changes to trial information