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.: PACTR202006868850398 Date of Approval: 26/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ASSESSMENT OF INTRAPARTUM REFERRALS AND USE OF MOBILE PHONE TECHNOLOGY TO IMPROVE MATERNAL-FETAL OUTCOMES IN SOUTH WESTERN UGANDA
Official scientific title ASSESSMENT OF INTRAPARTUM REFERRALS AND USE OF MOBILE PHONE TECHNOLOGY TO IMPROVE MATERNAL-FETAL OUTCOMES IN SOUTH WESTERN UGANDA
Brief summary describing the background and objectives of the trial There has been a global struggle to reduce maternal and perinatal morbidity and mortality (United Nations. Department of Public Information, 2009, World Health Organization, 2016). Some of the concerted efforts have been through the goals and targets of Millennium Development Goals (MDGs)and now the Sustainable Development Goals (SDGs). Although maternal mortality rates have reduced, we did not hit the target of 75% global reduction by the year 2015 according to MDGs and there is a fear that the developing countries may even fail to achieve the target of SDGs by the year 2030 (Lozano et al., 2011). Majority of these deaths occur in developing countries. Sub-Saharan region averages 546 deaths per 100,000 live births while high-income regions stand at an average of 12 maternal deaths per 100,000 live births(Alkema et al., 2016). In 2015, 64% of all global maternal deaths occurred in Africa(World Health Organization, 2018). In Uganda like any other developing country, we have poor health indicators especially maternal morbidity and mortality, and perinatal mortality. Maternal mortality rate and perinatal mortality rate are still very high at 336 per 100,000 live births and 38 per 1000 pregnancies respectively (Uganda Bureau of Statistics (UBOS) and ICF, 2018). The pregnancy related mortality ratios have stagnated over the years at 529, 524, 418, 438, and 368 during the years of 1995, 2001, 2006, 2011 and 2016 respectively(UDHS, 2016) Mbarara Regional Referral Hospital (MRRH) in South Western Uganda registers very poor maternal-fetal outcomes especially from intra-partum patients referred from lower health units. A six months record review at MRRH in department of Obstetrics and Gynecology (Feb-July 2018) showed a total of 26 maternal deaths, and intra-partum referrals contributed 65%. During the same period the department suffered 44 fresh still births and 47 macerated still births. Majority (74.4%) were delivered from referred patients with Isingiro district alone c
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Intrapartum care
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 20/03/2020
Actual trial start date
Anticipated date of last follow up 30/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL Link to be provided
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 Pre Referral Mobile phone communication between Health centre IVs and Regional Referral hospital Before each referral and the regional referral hospital calls the health centre IV for feedback after managing each referral 6 months A real-time pre-referral phone call from Health Care Workers at Health Centre IV to alert a contact person at Regional Referral Hospital, and the contact person at referral hospital alerts the responsible team at referral hospital maternity ward to prepare for management of such an intra-partum emergency referred in. This will be in addition to the standard-of-care (referral forms). The health centre IV will also be called by the team at referral hospital for feedback concerning the patient care and outcome so that the referral process is complete. 75
Control Group Referral letter Every referral should have a referral letter 6 months The control group will be the mothers in labor who will be referred with a referral letter showing the bio data of the referred patient, date, reason for referral any treatment before referral. No phone call will be made prior to referral of the mother in labor 102 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Intra-partum emergency referral from health centre IV to Regional Referral Hospital Failure to consent Having no evidence of referral documents Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 50 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 15/10/2019 Mbarara University of Science and Technology Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Not applicable Mbarara 1410 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome It will be a composite measure of maternal and fetal outcomes including maternal mortality, fetal mortality (early neonatal death, Fresh still birth, macerated still birth), Long hospital stay, and Disability like total abdominal hysterectomy, and organ failure. At admission, delivery time, 24hrs post delivery, daily during hospitalization and at discharge time
Secondary Outcome obstructed labour, caesarean section delivery, ruptured uterus, maternal sepsis, Apgar score at 5 minutes below 7, admission to a neonatal ICU. At admission , delivery time, daily during hospitalization and at discharge time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbarara Regional Referral Hospital Not Applicable Mbarara Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Kanyesigye Hamson Principal Investigator Not Applicable Mbarara 1410 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor SELF SPONSORSHIP Not applicable Mbarara 1410 Uganda Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Joseph Ngonzi and also my supervisor Not Applicable Mbarara 1410 Uganda
Prof Jerome Kabakyenga Not applicable Mbarara 1410 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator KANYESIGYE HAMSON kanyehamson@gmail.com +256752806921 Not applicable
City Postal code Country Position/Affiliation
Mbarara 1410 Uganda Lecturer Mbarara University of Science and Techology
Role Name Email Phone Street address
Public Enquiries Kabakyenga Jerome jkabakyenga@must.ac.ug +256701590409 Not applicable
City Postal code Country Position/Affiliation
Mbarara 1410 Uganda Lecturer Mbarara University of Science of Science and Technology
Role Name Email Phone Street address
Scientific Enquiries Joseph Ngonzi jngonzi@must.ac.ug +256703818336 Not applicable
City Postal code Country Position/Affiliation
Mbarara 1410 Uganda Lecturer Mbarara University of Science and Technology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will have controlled access to ensure participant's information protection. All individual participant data will be available for sharing. The researchers will also have access to data dictionaries, published data and results. The link will be provided.The researchers will then be able to do any appropriate analysis.Also study protocol with tools used for collecting data will be available for sharing. Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 8 months of completing data collection Controlled access criteria whereby researchers will have to get approval from RCT team or PI before accessing data including the dictionaries
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Link to be provided 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