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.: PACTR202110575846187 Date of Approval: 13/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Evidence-Based Guidelines Regarding Physical Activity on Maternal and Neonatal Health Outcome during Prenatal Period
Official scientific title Effect of Evidence-Based Guidelines Regarding Physical Activity on Maternal and Neonatal Health Outcome during Prenatal Period
Brief summary describing the background and objectives of the trial Evidence-based guidelines for promoting physical activity have been developed, but little information is available on how to disseminate effective interventions. Regular physical activity in all phases of life, including pregnancy, promotes health benefits. Maternal exercise is advantageous for placental and fetal growth as a result of it diverts blood toward muscles and skin and creates a transient hypoxic environment, which is the key to stimulate adequate placentation, and consequently a good utero-fetal circulation, additionally to potential oxidative stress, endothelial function, immunity and inflammation mechanism that are mediated by exercise. This study aimed to evaluate the effect of evidence-based guidelines regarding prenatal physical activity on maternal and neonatal health outcomes during the prenatal period.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Paediatrics
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Prevention
Anticipated trial start date 01/11/2021
Actual trial start date
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 64
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 randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Physical activity education for 8 weeks Pregnant women will be provided with general information about the benefits of prenatal exercise and the risks of physical inactivity; and informed, both what is the correct technique of each exercise and also how to modify it in case of discomfort during its execution with usual antenatal care 32
Control Group Usual antenatal care For8 weeks Pregnant women will receive usual antenatal care such as sonography 32 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
28 weeks of pregnancy. Non-risky pregnant women. Antenatal mothers with diabetes mellitus, heart disease or renal diseases, bleeding disorders. Inactive women before pregnancy. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 40 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 30/09/2019 Ethical Committee Faculty of Nursing Suez Canal University
Ethics Committee Address
Street address City Postal code Country
The Ring Road El Sheikh Zayed, Ismailia 3, Ismailia Governorate Ismailia 41511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Preeclampsia during 8 weeks
Primary Outcome Gestational diabetes during 8 weeks
Secondary Outcome Intact perineum during 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient obstetrics clinics Faculty of Medicine Suez Canal University The Ring Road ElSheikh Zayed Ismailia 3 Ismailia 41511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Asmaa abobakr ibrahim aboeleneen Elhaker, Al Ismailia, Ismailia Governorate Ismalia 41511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Obestetrics and Gynecological Nursing Faculty of Nursing Suez Canal University The Ring Rd, El Sheikh Zayed, Ismailia 3, Ismailia Governorate Ismalia 41511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Asmaa abobakr ibrahim aboeleneen Elhaker, Al Ismailia, Ismailia Governorate. Ismalia 41522 Egypt
Farida Kamel Yousef Ali 26 Elzaiton street Cairo Egypt Cairo 11724 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Principal Investigator Farida Ali faridakamel@gmail.com 00201008072503 26 Elzaiton street Cairo Egypt
City Postal code Country Position/Affiliation
Cairo 11724 Egypt Assistant Professor Community Nursing Department Faculty of Nursing Suez Canal University Egypt
Role Name Email Phone Street address
Scientific Enquiries Asmaa Aboeleneen asmaabakr2006@gmail.com 00201225444676 Elhaker street
City Postal code Country Position/Affiliation
Ismailia 41511 Egypt Lecturer Obestetrical and Gynecological Nursing Department Faculty of Nursing Suez Canal University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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