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.: PACTR202106591503674 Date of Approval: 07/06/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of self-care education on health outcomes in women with gestational diabetes and their newborns.
Official scientific title Impact of self-care education on health outcomes in women with gestational diabetes and their newborns: A randomized controlled trial
Brief summary describing the background and objectives of the trial Gestational diabetes is one of the biggest health challenges of the 21st century. It is indeed a frequent pathology constituting a real public health problem in many countries and in particular in Tunisia. The prevalence of gestational diabetes varies worldwide from 0.56% to 15.7%. Gestational diabetes must be screened for, diagnosed, and managed to prevent its fetal-maternal complications. Early diagnosis and treatment are not sufficient to guarantee optimal control of gestational diabetes. There is an inseparable link between screening, diagnosis, treatment, and education. In chronic conditions, self-care education is usually recommended to achieve optimal health outcomes. To the best of our knowledge, little was known about the effect of self-care education on gestational diabetes outcomes in pregnant women. This research aimed to assess the impact of a self-care education program on health outcomes in women with gestational diabetes and their newborns.
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 Education /Training
Anticipated trial start date 01/10/2020
Actual trial start date 05/10/2020
Anticipated date of last follow up 01/04/2021
Actual Last follow-up date 10/05/2021
Anticipated target sample size (number of participants) 120
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Selfcare education and usual care consultations 4 education sessions, and 1 consultation with the gynecologist every 2 weeks. 1 week of education, and 5 months of usual care consultations. Education about gestational diabetes control and self-management, insulin injection technique, healthy and personalized diet. The intervention was delivered by a multidisciplinary team (midwife, endocrinologist, gynecologist, nurse, nutritionist). 60
Control Group Usual care consultations once a month 5 months usual gestational diabetes review with the gynecologist. 60 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Confirmed diagnosis of gestational diabetes by the physician in the first trimester. Women who agreed to participate in the study. Women with chronic diabetes mellitus and/or other diseases. Women with physical or mental infirmity. Adult: 19 Year-44 Year,New born: 0 Day-1 Month 22 Year(s) 42 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 18/03/2021 Research and medical ethics committee of the Faculty of Medicine of Sousse.
Ethics Committee Address
Street address City Postal code Country
St Mohamed Karoui Sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome glycemia level before the childbirth on the day of delivery After 5-month follow-up
Primary Outcome Fetal macrosomia After 5-month follow-up
Secondary Outcome Number of hypoglycemia episodes in the past 5 months After 5-month follow-up
Secondary Outcome Number of hospitalizations in the past 5 months After 5-month follow-up
Secondary Outcome GD complications in the past 5 months After 5-month follow-up
Secondary Outcome GD complication on the day of delivery After 5-month follow-up
Secondary Outcome Fetal complications in the past 5 months After 5-month follow-up
Secondary Outcome Fetal complications on the day of delivery After 5-month follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Farhat Hached University Hospital St Ibn El Jazzar Sousse 4000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pharmatec School energy, Charguia 1 Tunis 2035 Tunisia Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sihem Chahed Chahed_sihem@hotmail.com +21697287137 Street Mohamed Karoui
City Postal code Country Position/Affiliation
Sousse 4002 Tunisia PhD candidate
Role Name Email Phone Street address
Public Enquiries Latifa Lassoued drlassoued@gmail.com +21698812066 Street Mohamed Karoui
City Postal code Country Position/Affiliation
Sousse 4002 Tunisia M.D. Gynecologist
Role Name Email Phone Street address
Public Enquiries Amel Maaroufi maaroufi_amel@yahoo.fr +21673102500 Street Ibn El Jazzar
City Postal code Country Position/Affiliation
Sousse 4000 Tunisia M.D. Endocrinologist
Role Name Email Phone Street address
Scientific Enquiries Maha Dardouri dardourimaha@gmail.com 0021658831292 Street Mohamed Karoui
City Postal code Country Position/Affiliation
Sousse 4002 Tunisia PhD in health sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD that underline the results reported in the published paper after deidentification. Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months after the study completion date (approximatively Juin 2022) The datasets generated during and analyzed during the current study are available from the principal investigator on reasonable request. The results will be published in scientific journals. The link and DOI of the paper will be available. Researches who provide a methodologically sound proposal.
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