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.: PACTR202407683095640 Date of Approval: 15/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of midwife-led intrapartum fetal heart rate monitoring using a hand-held Doppler at healthcare settings in northwest Ethiopia
Official scientific title Effectiveness, feasibility, and clinical outcomes of midwife-led intrapartum fetal heart rate monitoring using a hand-held Doppler at healthcare settings in northwest Ethiopia: an effectiveness-implementation hybrid type 2 design
Brief summary describing the background and objectives of the trial Close monitoring of fetal heart rate during the intrapartum period is very critical to neonatal survival and a mainstay for the reduction of newborn admission to the neonatal intensive care unit. An estimated 50% of the stillbirths occur during the intrapartum period. Almost all of those deaths and disabilities were caused by preventable conditions such as birth asphyxia. Hence, midwife-led intrapartum fetal heart rate monitoring using a simple to use, more efficient and effective, cost-affordable, and user-friendly devices, like a hand held Doppler, is promising in reversing the high incidence of stillbirth and early neonatal death and disabilities. However, there is a dearth of evidence about effectiveness and implementation outcomes of midwife-led intrapartum fetal heart rate monitoring using a hand-held Doppler at healthcare settings in Ethiopia. The aim of this project is to assess the effectiveness and implementation outcomes of midwife-led intrapartum fetal heart rate monitoring using a hand-held Doppler at healthcare settings in northwest Ethiopia, 2024. As such, an effectiveness-implementation hybrid type-2 approach using a parallel pragmatic cluster randomized controlled trial study design will be implemented at 8 primary health care settings in Central Gondar, northwest Ethiopia from January 1st to December 30th, 2024.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HHD
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 14/02/2024
Actual trial start date
Anticipated date of last follow up 14/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 672
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
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 Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Fetal Heart rate monitoring using a handheld Doppler by midwives Fetal heart rate (FHR) monitoring will be undertaken as per the Ethiopian national and World Health Organization (WHO) intrapartum FHR monitoring protocol. Accordingly, FHR monitoring using a hand-held Doppler will be performed every 30 minutes (each lasting for 1 minute) during active first stage of labour and every 15 minutes (each lasting 1 minute) during second stage of labour. Fetal heart rate (FHR) monitoring will be undertaken as per the Ethiopian national and World Health Organization (WHO) intrapartum FHR monitoring protocol. Accordingly, FHR monitoring using a hand-held Doppler will be performed every 30 minutes (each lasting for 1 minute) during active first stage of labour and every 15 minutes (each lasting 1 minute) during second stage of labour. The FHR monitoring will be undertaken a midwife or a team of midwives using a hand-held Doppler for healthy pregnant women (i., women with term, low-risk and singleton pregnancy) undergoing spontaneous labour. 336
Control Group Standar intrapartum FHR monitoring As per the Ethiopian national and WHO intrapartum FHR monitoring guideline. Accordingly, FHR will be monitored every 30 minutes during the active first stage of labour and every 15 minutes during the second stage of labour by any skilled birth attendants. FHR monitoring for 1 minute per auscultation. Usual intrapartum care (including FHR monitoring using a Pinnard stethoscope by midwives or any skilled birth attendants ) will be provided in the control arm. 336 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Healthy pregnant women (i., women with term, low-risk and singleton pregnancy), -Undergoing spontaneous labour,and -Early active first stage of labour during admission Those having previous or current obstetric complication(s) -Those labouring women arrived at the heath facility at advanced active first stage of labour -Those labouring women arrived at the heath facility at second stage of labour advanced active first stage of labou Adult: 19 Year-44 Year 18 Year(s) 49 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 24/01/2024 Institutional Review Board of University of Gondar
Ethics Committee Address
Street address City Postal code Country
University of Gondar Gondar 196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome secondary outcomes including: a composite of fresh stillbirths and immediate newborn deaths (i.e., newborn deaths within 24 hours); mode of delivery; time interval from labour to delivery; Apgar score at 1st and 5th minutes; attempted bag and mask ventilation; and admission to NICU The secondary outcomes are expected to be measured post-intervention.
Primary Outcome The effectiveness outcome (i.e., detection of abnormal FHR) and implementation outcomes including feasibility, reach-out, acceptability, maintenance, implementation and tailorability of midwife-led intrapartum FHR monitoring using HHD The primary outcomes are expected to be measured post-intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Gondar Chechela, Kebele 16 Gondar 196 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Laerdal Foundation Sentrum N-4003 Stavanger 556 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laerdal Foundation Sentrum N-4003 Stavanger 556 Norway Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
University of Gondar 16,Chechela Gondar 196 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Muhabaw Mihret muhabawshumye@gmail.com +251918473798 16, Chechela, Lideta
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Yohannis Matebe Johnhailu2002@gmail.com +25112787010 16, Chechela, Lideta
City Postal code Country Position/Affiliation
Gondar Ethiopia University of Gondar
Role Name Email Phone Street address
Public Enquiries Wagaye Chanie wefun23@gmail.com +251934588012 16, Chechela, Lideta
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia University of Gondar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification will be provided Clinical Study Report,Informed Consent Form,Statistical Analysis Plan The IPD will be provided within 12 months after data collection completion in this page Any one interested can access the IPD at this page in the form of summary results
URL Results Available Results Summary Result Posting Date First Journal Publication Date
URL will be given No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information