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.: PACTR201804003328818 Date of Approval: 14/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Enugu BRIDGES2 GDM PROJECT
Official scientific title A community-based randomised trial of lifestyle intervention using targeted shared care approach on pregnancy outcomes in Nigerian women with gestational diabetes mellitus but without diabetes mellitus
Brief summary describing the background and objectives of the trial GDM is defined as glucose intolerance during pregnancy, which resolves after delivery. Diabetes present before pregnancy is regarded as pre-pregnancy DM. GDM predicts increased risk of later DM in the mother and increased risk of metabolic abnormalities in the child later. Consequences of GDM in the short-term affect mother and baby causing increased incidence of macrosomia, stillborn, perinatal mortality, shoulder dystocia and perinatal injuries. GDM mothers experience increased Caesarean section rates, difficult delivery and risk of cardiovascular disease. Purpose of proposed intervention with objectives 1. To identify women with GDM in the rural, semi-urban and urban communities in Enugu State. Studies in Nigeria show increasing prevalence of GDM in communities: GDM rose from 2.98 in 2001 to 6.98/1000 pregnancies in 2015. Awareness for GDM is low hence the need for early diagnoses and appropriate management. 2. To increase awareness among primary/secondary/tertiary healthcare workers giving antenatal care as many do not understand the concept of GDM or its implications. 3. To evaluate the effectiveness of a targeted shared-care approach to treatment of GDM versus usual-care. A randomized control trial in China documented the usefulness of shared-care in improving outcome for mother and child. There is paucity of information on GDM epidemiology and prevention in Nigeria. 4.To increase community awareness for early registration for antenatal care as a way to improve outcome. There is low awareness and low registration for ANC in rural areas. 5. To increase regular antenatal attendance. ANC talks and community awareness campaigns will emphasize the importance of regular care. 6. To inculcate the practice of follow-up of women with GDM post-confinement to reduce future development of type 2-DM. 7. To increase community awareness for early detection and prevention of DM using lifestyle measures, the programme will be extended to the larger community
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diabetes mellitus,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/06/2018
Actual trial start date
Anticipated date of last follow up 01/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 514
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 Permuted block randomisation (with variable block sizes of 2, 4, 6, 8 and 10) Central randomisation by phone/fax Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (with variable block sizes of 2, 4, 6, 8 and 10) Central randomisation by phone/fax Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (with variable block sizes of 2, 4, 6, 8 and 10) Central randomisation by phone/fax Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Target Shared Care Participants will be seen every two weeks after recruitment until 36weeks gestation then weekly till delivery. Subsequently at 6weeks and 12weeks postnatal 28 weeks Intervention is based on modified protocol of the Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) study group. Personalized advice: intense diet, physical activity and weight optimization counseling, and strict self-monitoring of blood glucose from the dieticians and educators. 257
Control Group Usual Care/Standard of Care Participants will be seen every two weeks after recruitment until 36weeks gestation then weekly till delivery. Subsequently at 6weeks and 12weeks postnatal 28 weeks Intervention comprises of management strategies that constitute the standard of care for the women with GDM including: general health talks on clinic days on blood sugar control, dietary and exercise advice by a trained health educator. 257 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women 18 years and above; Pregnant women between 24th-28th who fulfill the diagnostic criteria of GDM: Diagnosis of GDM will be by one-step standard 75-gram 2-hour oral glucose tolerance test using the International Association of Diabetes and Pregnancy Study Group¿s criteria. Fasting Blood Sugar - equal or more than 5.2mmol/l to <7.0mmol/l 2-hours Post Prandial - equal or more than 8.0 mmol/l to <11.1mmol/l Pregnant women younger than 18 years; Pregnant women who fulfill diagnostic criteria for diabetes mellitus (fasting PG equal or more than 7.0 mmol/L, 2-hour PG equal or more than 11.1 mmol/L or HbA1c equal or more than 6.5% ); pre-existing/pregestational DM; multiple pregnancy; blood type incompatibility between mother and foetus, ABO type (pre-emptively exclude Rhesus negative mothers; and maternal diseases: such as chronic hypertension, thyrotoxicosis, or use of long-term medicines that could alter glucose metabolism. 18 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 Enugu State Ministry of Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Snugu State Secretariat Enugu 400001 Nigeria
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 Enugu State Ministry of Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Snugu State Secretariat Enugu 400001 Nigeria
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 UNTH Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Enugu-Port Harcourt Express Way Ituku-Ozalla 402139 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Glycaemic control (SMBG <5.3mmol/L, 2hours post-prandial 7.0mmol/L and HbA1C < 6.2%) At every antenatal clinic visit, delivery and at 6 weeks and 12 weeks postnatal visits
Primary Outcome Macrosomia defined as birth weight equal or more than 4000 grams At delivery of the baby
Secondary Outcome Incidence of Pregnancy Induced Hypertension At every antenatal clinic visit, delivery and at 6 weeks and 12 weeks postnatal visits
Secondary Outcome Registration for antenatal care At study commencement and thereafter monthly
Secondary Outcome Regular attendance for antenatal care At study commencement and thereafter monthly
Secondary Outcome Proficiency of health workers At study commencement and thereafter yearly
Secondary Outcome Perinatal complications: such as presence of shoulder dystocia Delivery, 6weeks Post natal visit, 12weeks visit (Terminal visit)
Secondary Outcome Community Knowledge of DM and GDM At the beginning, End of Study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital Enugu-Port Harcourt Express Road Ituku-Ozalla 402139 Nigeria
Enugu State University Teaching Hospital Park Avenue Enugu 400001 Nigeria
Agbani District Health Centre Ugbawka Rd Agbani 402101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
International Diabetes Federation Chaussee de La Hulpe, 166 B-1170 Brussels B-1170 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Diabetes Federation Chaussée de la Hulpe 166 Brussels 1170 Belgium Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Prof Ezekiel Uba Nwose School of Community Health Charles Sturt University Orange 2800 Australia
Dr Adeseye Akintunde Ladoke Akintola University of Technology, Ogbomosho-Ilorin Road Ogbomosho 210214 Nigeria
Prof Timothy Skinner Kobenhavns Universitet, Institut for Psykologi, Center for Sundhed og Samfund, Kobenhavns Universitet, Oster Farimagsgade 2A Kobenhavns 1353 Denmark
Victor Maduabuchi OGUOMA Child Health Division, Menzies School of Health Research Darwin NT 0810 Australia
Ekenechukwu Young UNTH, Enugu-Port Harcourt Express Way Ituku-Ozalla 402139 Nigeria
Euzebus Ezugwu UNTH, Enugu-Port Harcourt Express Way Ituku-Ozalla 402139 Nigeria
Sam Egwuonwu State Health Board, No 1 Coliery Road Enugu 400001 Nigeria
Dr Sunny Mbah ESUTH, Park Avenue Enugu 400001 Nigeria
Dr Ejiofor Ugwu ESUTH, Park Avenue Enugu 400001 Nigeria
Dr Ikechukwu Obi UNTH, Enugu - Port Harcourt Express Way Ituku-Ozalla 402139 Nigeria
Prof Chinwuba Ijoma UNTH, Enugu-Port Harcourt Express Way Ituku-Ozalla 402139 Nigeria
Dr Uchenna Ijoma UNTH, Enugu-Port Harcourt Express Way Ituku-Ozalla 402139 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ifeoma Ulasi IFEOMA.ULASI@UNN.EDU.NG +2348033262503 UNTH, ENUGU-PORT HARCOURT EXPRESS WAY
City Postal code Country Position/Affiliation
ITUKU-OZALLA 402139 Nigeria PROFESSOR/ CONSULTANT PHYSICIAN
Role Name Email Phone Street address
Public Enquiries EUZEBUS EZUGWU EUZEBUS.EZUGWU@UNN.EDU.NG +2348037020295 UNTH, ENUGU-PORT HARCOURT EXPRESS WAY
City Postal code Country Position/Affiliation
ITUKU-OZALLA 402139 Nigeria SENIOR LECTURER/CONSULTANT GYNAECOLOGIST
Role Name Email Phone Street address
Scientific Enquiries EKENECHUKWU YOUNG EKENECHUKWU.YOUNG@UNN.EDU.NG +2348037237347 UNTH, ENUGU-PORT HARCOURT EXPRESS WAY
City Postal code Country Position/Affiliation
ITUKU-OZALLA 402139 Nigeria SENIOR LECTURER/CONSULTANT PHYCISIAN
REPORTING
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