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.: PACTR201804003312421 Date of Approval: 07/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title maternal exercise in preeclampsia
Official scientific title Effect of Maternal Exercise Program on Fetal Growth in Preeclampsia¿
Brief summary describing the background and objectives of the trial Background: preeclampsia is the pregnancy associated disorder that serious cause to ¿maternal and fetal complication. Fetal growth may be severely affected. Maternal exercise ¿program has been suggested to decrease preeclampsia complications for both mother and ¿fetus.¿ Objective: The aim of this study was to assess the effect of maternal exercise program on ¿fetal growth in preeclampsia.¿
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied preeclampsia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/09/2017
Actual trial start date 03/09/2017
Anticipated date of last follow up 29/01/2018
Actual Last follow-up date 31/01/2018
Anticipated target sample size (number of participants) 38
Actual target sample size (number of participants) 30
Recruitment status Stopped early/ terminated
Publication URL http://www.journalonweb.com/bfpt/
Secondary Ids Issuing authority/Trial register
research ethical comittee cairo university P.T.REC/012/001848
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group maternal exercise program plus anti hypertension medicaton 3 times per week (60 min /session) for exercise& twice/daily for medication from the 27th week of gestation until giving birth areobic exercise and resistance exercise plus Hydralazine& Labetalol 15
Control Group Traditional anti hypertension medication twice/daily from the 27th week of gestation until giving birth Hydralazine& Labetalol 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿. Fetus with 27th weeks of gestation up to first 12hrs of birth.¿ ¿. Fetus whose mothers suffered from pre-eclampsia.¿ ¿. Fetus whose mothers age 20-35 years.¿ ¿. Fetus whose mothers were primigravida.¿ ¿. Fetus whose mothers had BMI less than 35.¿ ¿. ¿ Fetus whose mothers delivered by elective caesarean section at 34 week ¿of ¿gestation based on the recommended ¿reference¿(NICEGuideline).(¿ ¿. Fetus whose mothers suffered from any problem that could affect results at ¿the end of the study were excluded from the commence of the study ¿problems ¿include: ¿ ¿¿ Cervical insufficiency.¿ ¿ ¿¿ Vaginal bleeding.¿ ¿¿ Heart disease.¿ ¿¿ Systemic lupus erythematous.¿ ¿¿ Any other medical condition that affect blood pressure¿¿.¿ ¿. Fetus whose mothers suffered from eclampsia & uncontrolled ¿hypertension would be early terminated during the study.¿ ¿. Stillbirth fetus.¿ ¿. Fetus who suffered from any congenital anomalies.¿ 20 Year(s) 35 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 11/02/2018 research Ethical comittee cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzat st in front of Ben El-sarayat Traffic- Dokki-Giza cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome fetal growth(head circumference measurement,biparietal diameter,abdominal circumference). at 27th week of gestation and every two weeks until giving birth
Secondary Outcome fetal weight at 27th week of gestation and every two weeks until giving birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
at the Inpatient Clinic of Mansoura University Hospitals¿ elgomharaya mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
nill
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor faculty of physical therapy cairo university 7 ahmed elzeat eldoki cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sally Ashraf Asker 23Elkholiy st. mansoura-eldakhlia mansoura non Egypt
Faten Hassen Abdelazim Ahmed alzat st GIza-Egypt cairo non Egypt
Naglaa Ahmed Zaky Ahmed alzat st GIza-Egypt cairo non Egypt
Alaa Wageh Elgomheria st-Dakhilia mansoura non Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faten Abdelazim Faten.hassan@pt.cu.edu.eg 00201008554818 Ahmed alziat st.Giza -Egypt
City Postal code Country Position/Affiliation
cairo Egypt Professor of Pediatric Physical Therapy,Cairo University¿
Role Name Email Phone Street address
Public Enquiries Alaa Wageh wagehalaa@yahoo.com 002001006730708 Elgomheria st , Faculty of Medicine, Mansoura University
City Postal code Country Position/Affiliation
mansoura Egypt Lecturer of Gynecology and Obstetrics, Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Naglaa Zaky naglaaomsa_m@hotmail.com 00201002800136 Ahmed alziat st.Giza ¿Egypt
City Postal code Country Position/Affiliation
cairo Egypt Assistant Professor of Pediatric Physical Therapy,Cairo University¿
REPORTING
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