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.: PACTR202305607000259 Date of Approval: 05/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Moyo Device on Intrapartum Detection of Abnormal Fetal Heart Rate: A Randomized Controlled Trial in Ethiopia
Official scientific title Effectiveness of intermittent fetal heart rate monitoring using Moyo or Pinard fetoscope on Intrapartum Detection of Abnormal Fetal Heart Rate and adverse birth outcomes in general hospitals of Southern Ethiopia: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background: To enable more timely detection of a hypoxic fetus, Laerdal Global Health has recently developed the Moyo FHR monitor, however, little is known about its effectiveness from multicenter context trials in resource-limited settings, particularly in East Africa. Design: An open-label randomized controlled trial with a one-to-one allocation ratio Setting: The study was conducted at five public general hospitals in southern Ethiopia from September 28, 2022, to February 28, 2023. Participants: A total of 2518 low-risk women selected by cluster sampling technique in the study period were enrolled in the study. Outcome measures: The primary outcome measure was fetal heart rate, and the secondary outcomes were neonatal outcomes, and the obstetrics time interval. Feat heart rate was measured by either the intervention or the control device every 30 minutes for the first stage of labor and every 15 minutes for the second stage of labor, in both cases fetal heart rates less than 110 and greater than 160 were categorized as abnormal. Neonatal outcomes such as Apgar score (the first minute and fifth minute), neonatal intensive care unit admission, and early neonatal death were secondary outcomes. Moreover, the obstetric time interval in this trial was a secondary outcome measured by the time from admission to abnormal fetal heart rate detection, admission to delivery, and abnormal fetal heart rate to delivery.
Type of trial RCT
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 Early detection /Screening
Anticipated trial start date 01/07/2022
Actual trial start date 28/09/2022
Anticipated date of last follow up 01/11/2022
Actual Last follow-up date 28/02/2023
Anticipated target sample size (number of participants) 2518
Actual target sample size (number of participants) 2518
Recruitment status Completed
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Moyo Fetal heart rate monitor Feat heart rate was measured by either the intervention or the control device every 30 minutes for the first stage of labor and every 15 minutes for the second stage of labor, in both cases fetal heart rates less than 120 and greater than 160 were categorized as abnormal. For primary outcomes, it was employed in the active first stage and second stage of labor. Until delivery of childbirth through the first 24 hours post delivery for the secondary outcomes Moyo (Figure 1) (Moyo, Laerdal Global Health, Stavanger, Norway) is a novel strap-on FHR monitor equipped with a rechargeable battery, containing a nine-crystal Doppler ultrasound sensor, which is believed to facilitate the rapid identification of FHR within 5 seconds. Its detection area is about 15 cm in radius, which makes palpation and aiming for heartbeats less critical. The device can also differentiate maternal pulse from FHR with the help of the built-in set of dry electrodes. Women randomized to the Moyo arm received information on how the device is used by the enrolling midwife before the device is strapped on. A research midwife listened to the FHR during the last 10 minutes of every half hour, particularly before and immediately after a contraction. The research midwife visited the women every 30 minutes to check and record the FHR reading or in case of an abnormal FHR alarm from Moyo[24]. FHR monitoring using the Moyo device and Pinard fetoscope continued until the end of the second stage or immediately before the start of a CS. A training flowchart is also provided to facilitate decision-making and timely responses. 1259
Control Group Pinard Fetoscope Feat heart rate was measured by either the intervention or the control device every 30 minutes for the first stage of labor and every 15 minutes for the second stage of labor, in both cases fetal heart rates less than 120 and greater than 160 were categorized as abnormal. For primary outcomes, it was employed in the active first stage and second stage of labor. Until delivery of childbirth through the first 24 hours post delivery for the secondary outcomes In the control arm, women were monitored with the standard protocol of FHR monitoring every 30 min in the first stage and 15 min in the second stage using a Pinard fetoscope. A midwife auscultated the FHR for a complete minute with the Pinard fetoscope. The midwife on duty recorded fetal heart rate with the Pinard fetoscope as it is a normal practice in the ward. A research midwife recorded the FHR during the last 10 minutes of every half hour with the Pinard fetoscope, particularly before and immediately after a contraction. The research midwives were required to report any abnormalities in fetal heart rate to the doctor in charge for assessment. 1259 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Participants with an estimated gestational age of ≥37 weeks - Participants with ≥4 cm cervical dilatation at admission -Participants scheduled for cesarean section (CS) -Participants with multiple pregnancies -Participants with abnormal FHR on admission i.e. absent; FHR<110 or FHR>160 beats/minutes (BPM)or undetectable -Participants with common pregnancy complications -Participants with precipitous delivery -Participants with ≥9 cm cervical dilatation at admission. Adult: 19 Year-44 Year,New born: 0 Day-1 Month 15 Year(s) 45 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 12/04/2022 Arba Minch University Institutional Research Ethical review board
Ethics Committee Address
Street address City Postal code Country
Located 5km south of Arba Minch University main campus on the road to Addis Ababa Arba Minch 4400 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure was abnormal FHR defined as normal (110 to 160 beats/min (bpm) throughout labor and delivery) or abnormal (absent, <110 or >160 beats/min). It was measured at ‘0’, ‘5th’, and 10th minutes of the initial contact with the study participant. The measurement of FHR continued till the woman delivered at an interval of every 30 minutes in the first stage of labor and every 15 minutes during the second stage of labor. The start of FHR auscultation within the first 10 minutes following the uterine quiescence. The report or documentation for the control arm was on the prepared follow-up sheet, where the count would be rounded to the nearest 5 beats per minute increment. Abnormal FHR is reached after at least one confirmed measurement at any point during labor. every 30 minutes in the first stage of labor and every 15 minutes during the second stage of labor
Secondary Outcome Secondary outcomes included the Apgar score at first and fifth minutes (abnormal is defined as an Apgar score <7); mode of delivery (Spontaneous vaginal delivery, operative delivery: CS and instrumental delivery); perinatal outcome at birth (i.e., normal, admission to the neonatal unit, or FSB), the outcome at 24-h (i.e., normal, still admitted to the neonatal unit). Obstetric time intervals included: admission to abnormal FHR detection, admission to delivery, from abnormal FHR detection to delivery. every 30 minutes in the first stage of labor and every 15 minutes during the second stage of labor
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Arba Minch General Hospital It is located at 505 km southwest of Addis Ababa on the road to Addis Ababa. Arba Minch 4400 Ethiopia
Jinka General Hospital Located in the hills north of the Tama Plains, this town is the capital of the Debub Omo Zone of the Southern Jinka 4420 Ethiopia
Sawla General Hospital Main road from Addis Ababa to wolayita Sodo town, southwest direction approximately 250km away Felege selam 5040 Ethiopia
Dr Bogalech Gebre Memorial General Hospital Main road from Addis Ababa to Halaba Kulito town, approximately 276km away in southern Ethiopia Durame 5040 Ethiopia
Halaba Kulito General Hospital Main road from Addis Ababa to Alaba Kulito town, approximately 242 km away in South Ethiopia Alaba none Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Laerdal Foundation 4003 Stavanger Norway Sentrum 556 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laerdal Foundation 4003 Stavanger Norway Sentrum 556 Norway Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kassahun Fikadu kasfika@gmail.com 0920136228 In front of Lucy caffe on the main road to Addis Ababa
City Postal code Country Position/Affiliation
Arba Minch 4400 Ethiopia Assistant Professor in Clinical Midwifery at Arba Minch University college of Medicine and Health Sciences
Role Name Email Phone Street address
Public Enquiries Tamiru Shibiru drtamshib1@gmail.com 0911704767 In front of Lucy caffe on the main road to Addis Ababa
City Postal code Country Position/Affiliation
Arba Minch 4400 Ethiopia Associate professor in Internal medicine at Arba Minch University
Role Name Email Phone Street address
Scientific Enquiries Mesfine Kote messikid@gmail.com 0911005626 In front of Lucy caffe on the main road to Addis Ababa
City Postal code Country Position/Affiliation
Arba Minch 4400 Ethiopia Assistant professor of Public Health at Arba Minch University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that support the findings of this study will be made available following deidentification. This will be done immediately following publishing, with no time limit. The data can be used for meta-analysis by any interested researcher whose planned use of the data has been approved by the review committee. Clinical Study Report No end time The data can be used for meta-analysis by any interested researcher whose planned use of the data has been in line with the intended purpose.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 26/04/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 04/05/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information