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.: PACTR201801002825282 Date of Approval: 30/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Third trimester Pilates on Obstetric and neonatal outcomes. A Randomized control Trial.
Official scientific title Effect of Third Trimester Prenatal Pilates on Obstetric and Neonatal Outcomes.A Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Pregnancy profoundly alters the women physiology from the moment of conception; thus, there is change in all body system to fulfill the requirement of the body.The World Health Organization (WHO) (2010) and the American College of Sports Medicine (ACSM) (2002) have issued evidence-based recommendations indicating the beneficial effects of exercise including reducing the risk for coronary heart disease, cardiovascular disease, metabolic syndrome and systemic inflammation. Aerobic/anaerobic exercises in pregnancy decrease the risk of developing gestational diabetes mellitus, preeclampsia, caesarean section rate, reduced symptoms from low back pain and improves mental state, insomnia and fatigue. Pilates exercise is a low impact and effective anaerobic form of exercise option that improves strength, posture, balance, flexibility and muscle tone.Pilates exercise is one of the commonly practiced prenatal exercises in antenatal classes which can be performed in sitting and side lying when a supine position is contraindicated during second and third trimester and because of the gentle nature of many of the exercises in pilates, it is increasingly being sought by mothers during and after pregnancy. Very little has been published on the effects of prenatal pilates in pregnancy; hence, the apparent need for this study to determine the effect of pilates on obstetric and neonatal outcomes.Several benefits of pilates in pregnancy have been documented to include alleviation of stress and tension, positive mental attitude, prevention of a number of difficulties associated with pregnancy such as biomechanical changes that lead to back, neck, and shoulder pain. However, the effect of pilates has not been reported on pregnancy and neonatal outcomes and thus, the purpose of the study.The objective of the study is to determine the effect of prenatal pilates on length of pregnancy,length of labour,mode of delivery,fetal heart rate,fetal Apgar score and Fetal weight.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetric and Neonatal Outcomes,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 05/06/2017
Actual trial start date 04/09/2017
Anticipated date of last follow up 13/11/2017
Actual Last follow-up date 24/11/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known Bayero University Kano
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 Allocation sequence was generated using Stat Trek Computerized number generated a total of 100 random numbers.Numbers were randomly selected from within the range of 0 to 99999. Duplicate numbers were not allowed The code was concealed from the person allocating the participants using sealed opaque envelopes.Participants were given envelopes after they consented to participate in the study at the antenatal unit of the hospital and they were asked to take the envelopes to physiotherapy department. Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pilates exercise twice weekly for eight weeks and above one hour Pilates exercises according to POGP which involves Transverse Abdominus activation and deep breathing exercises (exhale-contract/Inhale-relax) for all exercises.Strengthening exercises to upper limbs, lower limbs,pelvic floor muscles and core stabilty with pair of 1kg dumb bell,therabands and gym ball for each participants.then stretches and relaxation exercises. 20
Experimental Group Aerobic Exercise twice weekly for eight weeks and above one hour A 10 minute walking and stretching warm up and cool down. Step aerobics with wooden steps(L20/B12/H3 inches) for 30 minutes. 20
Control Group Control group once weekly for eight weeks and above 0ne hour routine antenatal care and physiotherapy education classes that involves posture corrections and ergonomicspregnancy, Role of physiotherapy in obstetrics.Participants were advised to engage in 30 min walking twice weekly at home. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. singleton pregnancy at 28-32 weeks of gestation. 2. Healthy Pregnant women at 28-32 weeks of gestation. 1. Twin Gestation because its a high risk pregnancy. 2.Past and present medical history of chronic heart or lung disease, diabetes,hypertension, epilepsy,hyperthyroidism, severe anemia, premature delivery or unexplained fetal death. 3. Involved in any exercise during pregnancy. 16 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 17/06/2017 Aminu Kano Teaching Hospital Health Research Ethics Commitee.
Ethics Committee Address
Street address City Postal code Country
No 2 zaria road. Kano 3452 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 17/06/2017 Aminu Kano Teaching Hospital Health Research Ethics Commitee.
Ethics Committee Address
Street address City Postal code Country
No 2 zaria road. Kano 3452 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome lenght of labor during delivery recorded in hours
Primary Outcome Fetal Apgar 1.1-minute after birth scored between 0-10. 2.5-minute after birth scored between 0-10.
Primary Outcome Fetal heart rate At delivery
Secondary Outcome length of pregnancy At delivery recorded in weeks
Secondary Outcome Mode of delivery At delivery
Secondary Outcome Bloodloss After delivery
Secondary Outcome Perineum condition After delivery
Secondary Outcome Fetal weight After delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Antenatal Clinic of Aminu Kano Teaching Hospital. No2 Zaria Road Kano PMB 3411 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
ANHAS NIGERIA LIMITED NO 29 Justice Dahiru Mustapha Avanue, City Centre Kano. Kano 3011 Nigeria
Physiolates Physiotherapy and Fitness Clinic. No 16 Sokoto Road, nassarawa GRA kano. Kano 3011 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ANHAS NIGERIA LIMITED NO 29 Justice Dahiru Mustapha Avanue, City Centre Kano. Kano 3011 Nigeria Commercial Sector/Industry
Secondary Sponsor Physiolates Physiotherapy and Fitness Clinic. No 16 Sokoto Road, nassarawa GRA kano. Kano 3011 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Bayero University Kano Gwarzo Road kano Kano PMB 3411 Nigeria
Aminu Kano Teaching Hospital No2 Zaria Road Kano PMB 3452 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aisha A Harazumi ayusharazumi@gmail.com +2348034204343 No 32 GTC, Quarters, State Rd
City Postal code Country Position/Affiliation
Kano 671101 Nigeria Member Medical Rehab Therapist Board Nigeria and Nigerian Soc Physiotherapy
Role Name Email Phone Street address
Public Enquiries Shmaila M Hanif shellshell@yahoo.com +238038871817 No 5 Matan Fada Road
City Postal code Country Position/Affiliation
Kano 671101 Nigeria Assoc Prof Ept Physiotherapy, Faculty Health Sciences, Bayero Univ, Kano Nigeria
Role Name Email Phone Street address
Scientific Enquiries Shmaila M Hanif shelllshelll@yahoomail.com +238038871817 No 5 Matan Fada Road
City Postal code Country Position/Affiliation
Kano 671101 Nigeria Assoc Prof Dept Physiother, Faculty of Health Sciences, Bayero Univ, Kano Nigeria
REPORTING
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