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.: PACTR202105503866224 Date of Approval: 12/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of maternal ambulation on labour duration
Official scientific title Effects of Maternal Ambulation During Labour on Duration and other Labour Outcomes at University College Hospital Ibadan: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background: Labour is the physiological process that results in the birth of a baby, delivery of the placenta and the signal for lactation to begin. There is no ideal length of labour for all women but morbidity increases when labour is too fast (precipitous) or too slow (prolonged). There is a greater incidence of fetal hypoxia and need for operative delivery associated with longer labour. Interventions such as maternal ambulation is believed to confer advantages on both the fetus and the mother in relation to birth outcomes such as duration of labour, pain perception in labour etc. Objective: To determine the effect of maternal ambulation during first stage of active labour on labour duration and other maternal /neonatal outcomes at the University College Hospital [UCH] Ibadan, Nigeria.
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 Supportive care
Anticipated trial start date 02/03/2020
Actual trial start date 03/03/2020
Anticipated date of last follow up 08/05/2021
Actual Last follow-up date 11/09/2020
Anticipated target sample size (number of participants) 282
Actual target sample size (number of participants) 282
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ambulation in labour. Participants in the Experimental group were allowed to ambulate every 30 minutes for each hour they spent in labour. Ambulation I this case includes walking, leaning against the wall, walking on all fours. 30 minutes for every hour spent in labour Participants in the Experimental group were allowed to ambulate every 30 minutes for each hour they spent in labour. Ambulation I this case includes walking, leaning against the wall, walking on all fours. 141
Control Group Lay in bed Whole duration of labour The whole time spent in labour. Participants in the control group lay supine or in their side throughout labour 141 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting singleton term pregnant women Must be in active first stage of labour (cervical dilatation ≥ 4cm) at UCH Ibadan. Patient with non-cephalic presentation. Patient with previous uterine scar. Patient with medically indicated need for frequent dosing of analgesia or other chronic medical conditions. Patients with contraindications to vagina delivery. Adult: 19 Year-44 Year 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 18/07/2019 Institute for Advance Medical Research And Trainning
Ethics Committee Address
Street address City Postal code Country
College of Medicine University of Ibadan Ibadan 234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean duration of labour in the ambulatory and non-ambulatory groups Secondary Outcome: Mean differences in pain score by the women in each group. Proportion of mode of delivery by women in each group - spontaneous vaginal delivery, operative vaginal or caesarean section. Prevalence of oxytocin augmentation in each group. Significant differences in neonatal APGAR score in each group. At delivery of the fetus
Secondary Outcome Mean differences in pain score by the women in each group. Proportion of mode of delivery by women in each group - spontaneous vaginal delivery, operative vaginal or caesarean section. Prevalence of oxytocin augmentation in each group. Significant differences in neonatal APGAR score in each group. Pain score was measured using the Numerical Rating scale every 2hours in labour while the other parameters were appropriately measured at specified point
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Ibadan Queen elizabeth Road, Mokola Ibadan Ibadan 234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Raymond Takpe University college hospital ibadan Ibadan 234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self University college hospital ibadan Ibadan 234 Nigeria Self
COLLABORATORS
Name Street address City Postal code Country
Dr Folashade Bello University College Hospital Ibadan Ibadan 234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Raymond Takpe raymondtakpe@gmail.com +2348169410798 University college hospital ibadan
City Postal code Country Position/Affiliation
Ibadan 234 Nigeria University college hospital ibadan
Role Name Email Phone Street address
Public Enquiries Raymond Takpe raymondtakpe@gmail.com +2348169410798 University college hospital ibadan
City Postal code Country Position/Affiliation
Ibadan 234 Nigeria University college hospital ibadan
Role Name Email Phone Street address
Scientific Enquiries Raymond Takpe raymondtakpe@gmail.com +2348169410798 University college hospital ibadan
City Postal code Country Position/Affiliation
Ibdan 234 Nigeria University college hospital ibadan
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Informed Consent Form,Study Protocol Immediately the study is published. This will be available for 3years. Data may be requested by researchers doing same reacher or pepe and organisations interested in maternal and fetal outcomes especially in low resource setting like where this study was done. Data access will be controlled and a formal request will be made to the principal investigator and my superviso. The request will be reviewed by an independent board comprising the ethical review board that gave the initial aproval at the institute for Advance Medical Research. If the request is satisfactory approval may be given to analyse the data or used for it's intended purpose.
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