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.: PACTR202202670656570 Date of Approval: 14/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Quasi-Experimental Study to Determine the Association Between the Provision of Prenatal Ultrasound and Neonatal and Maternal Outcomes in Rural Uganda
Official scientific title Quasi-Experimental Study to Determine the Association Between the Provision of Prenatal Ultrasound and Neonatal and Maternal Outcomes in Rural Uganda
Brief summary describing the background and objectives of the trial The general objective of this project is to study the impact obstetric US services have on maternal and neonatal morbidity and mortality, including stillbirth, in the LMIC setting. The following are being considered: Primary Objective: 1) To assess the impact having an US program at rural Health Centers in an LMIC has on the location of delivery. Secondary Objectives: 1.) To assess the whether having an US program at rural Health Centers in an LMIC setting will lead to a decrease in the number of neonates requiring resuscitation in the form of bag-mask ventilation at delivery. 2) To assess whether having an US program at rural Health Centers in an LMIC setting will lead to a decrease in the number of maternal hemorrhage cases for women scanned at these centers. 3) To estimate the effect of an obstetric US program in a rural LMIC setting on stillbirth, neonatal mortality with the first 298 days post-delivery, and maternal death within the first 42 days post-delivery. 4) To examine how an ultrasound program influences referral and management decisions at rural Health Centers in an LMIC setting. 5) To compare the effect of an US program in the rural LMIC setting with the effect in a refugee camp setting. 6.) To assess the impact of an US program in the rural LMIC setting on Apgar scores assigned to infants at delivery.
Type of trial CCT
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 Provision of ultrasound and its impact on maternal, neonatal and child health
Anticipated trial start date 01/12/2021
Actual trial start date
Anticipated date of last follow up 09/10/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 3500
Actual target sample size (number of participants)
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Provision of Ultrasound services At least three ultrasound services per pregnancy period. Depending on when the women was enrolled 1 one and a half year The intervention will comprise three elements: training of health workers, mentorship of trainees by ITW staff, and provision of and maintenance of US and IT equipment at the 7 intervention sites. The trainees are nurses, midwives, and Clinical Officers selected from the study health facilities. The training will be focused on basic obstetric ultrasound. It will be conducted by ITW trainers, including a radiologist and experienced radiographers/sonographers. The training will be conducted in two phases: an initial residential didactic/hands-on phase lasting 1 month followed by a field practicum/mentorship phase lasting 11 months. During the practicum/mentorship phase, the trainees will be mentored by ITW-trained field sonographers on a daily and trainers on a quarterly basis. In addition, obstetric US sweeps will be sent by the trainees to the ITW team of radiologists and radiographers in Kampala and the USA for review and feedback. During the mentorship and follow-up period, high-risk mothers will be identified and those who require specialized care should be referred to higher-level facilities for further management. 2500
Control Group None N/A N/A None 1000 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
This study will include all pregnant women who will voluntarily consent to participate in the study, between the ages of eighteen- and forty-nine-years attending routine antenatal care or scheduled for an obstetric ultrasound at one of the study sites, and their neonates The study will exclude: a. All women who do not sign a consent form b. All women on non-routine obstetric ultrasound scan c. All women below eighteen years of age & above fifty or more years of age Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 19/11/2021 Mengo Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Sir Albert Cook Road, Mengo Kampala 7161 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The study will have 2 co-primary outcomes: i. Referral of the mother to a higher level of care prior to delivery ii. Location of delivery at the time of delivery
Secondary Outcome The study will have several secondary outcomes. These are need for neonatal resuscitation in the form of bag-mask ventilation at delivery, Apgar scores assigned to the neonate following delivery, maternal post-partum hemorrhage, stillbirth, neonatal death up to 28 days post-delivery, maternal death up to 42 days post-delivery. At delivery and within 28 days of delivery for neonates and within 42 days of delivery for mothers
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nyumanzi HCII Ayilo HCIII Pagirinya HCIII Nyakasiro HC III Rubanda Kakore HC III Rubanda PHCP HC III St. Mark Ndama HC III. Adjumani Mitooma Rukungiri Uganda Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Imaging The World Org P.O BOX 25, CHARLOTTE VERMONT 05445 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Imaging the World Corp P.O.Box 25, Charlotte Vermont 05445 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Delia Horn delia.horn@uvmhealth.org 8023459213 111 Colchester Ave
City Postal code Country Position/Affiliation
Burlington 05401 United States of America Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Kristen DeStigter kristen05445@gmail.com 8027341440 P.O Box 25,
City Postal code Country Position/Affiliation
Charlotte VT 05445 United States of America Cofounder and President
Role Name Email Phone Street address
Scientific Enquiries Joyce Naiga joyce.naiga@imagingtheworld.org +256782829663 St Peter Secondary School, Naalya, Kampala
City Postal code Country Position/Affiliation
Uganda Uganda Research team member
Role Name Email Phone Street address
Public Enquiries Delia Horn delia.horn@uvmhealth.org 8023459213 111 Colchester Avenue
City Postal code Country Position/Affiliation
Burlington 05401 United States of America Assistant Professor of Pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual deidentified participant data will be shared amongst study personnel during the study period and subsequent data analysis. Data will be shared with study personnel via REDCap accessed by the Primary Investigator Dr. Delia Horn or other key study personnel. We plan to share individual deidentified patient data in the form of published results in an open-access journal following data analysis. This will be data related to our stated primary and secondary outcomes. All data will be de-identified at the time that it is collected and will remain de-identified throughout the study and at any points that it is shared. Informed Consent Form,Study Protocol de-identified IDP will be shared amongst key study personnel during the study time frame of 1/2022-9/2023. We intend for de-identified data regarding the stated outcomes of interest to subsequently be shared via open-access journal publication. Data will be shared amongst study personnel for this quasi-experimental study analysis. De-identified data will be gathered and accessed via REDCap but analyzed using a difference in differences analysis, estimating logit regressions to predict our various outcome variables. We will be using SAS for data cleaning and building the data set, STATA 16 for regression analysis.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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