Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202306468079442 Date of Approval: 21/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects Of Maternal Upright Birth Position On Reducing The Second Stage Of Labour and Perineal Tear Among Pregnant Women Delivering In government Hospitals In Dar es Salaam.
Official scientific title Determining The Effects Of Maternal Upright Birth Position On Reducing The Second Stage Of Labour and Perineal Tear Among Pregnant Women Delivering In government Hospitals In Dar es Salaam; A Randomized Control Trial.
Brief summary describing the background and objectives of the trial A prolonged active stage of labour leads to complications and adverse effects for both mother and newborn, and among of it causes is a horizontal birth position, which acounts for 91.4 to 99.7% of all vaginal births in Tanzania. Despite efforts employed by the government of Tanzania, still, the incidences of prolonged labour have remained quite higher. The study purpose is to determine the effect of the upright birth position on reducing the duration of the second stage of labour, perineal tear, maternal birth satisfaction, and apgar score among women delivering in government hospitals in Dar es Salaam-Tanzania. This will be a randomized controlled trial that will include 116 participants in experimental and 116 participants in the control group. A simple random sampling will be used to select 4 out six hospitals with adjustable beds in Dar es Salaam. In each hospital, participants will be randomly allocated to an either experimental group or control group whereby, the experimental group will be directed and helped to assume an upright birth position during the second stage of labour while the control group will be allowed to assume the horizontal position. Data will be analysed using SPSS version 28. An independent t-test and one-way MANOVA will be used to compare the effects of intervention between the experimental and control, and a p-value of < 0.05 will be regarded as a statistically significant difference
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 Prevention
Anticipated trial start date 09/10/2023
Actual trial start date 11/10/2023
Anticipated date of last follow up 29/12/2023
Actual Last follow-up date 31/12/2023
Anticipated target sample size (number of participants) 232
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 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 Upright Birth Position Not Applicable 0-3 hours for the second stage duration. In the squatting position, while standing on the delivery bed with both legs apart and knees flexed, the client will hold metals on the left and right sides of the delivery bed and the trunk will be kept straight upward however she may lean forward or backward to increase flexibility. For the kneeling position participant will be told to kneel on the delivery bed then she will lean forward and supports herself on the palms of her hands. In hands knees position, each participant will be taught and assisted to assume the on all four positions during the second stage, when there is no contraction participant will be allowed to rest in any position and the process will be repeated until the baby delivered. 116
Control Group Lithotomy Birth Position Not Applicable 0-3 hours for the second stage duration A recumbent position where a client is lying on her back with her hips flexed and abducted while her knees are flexed. 116 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Term pregnancy • Age between 20-35 years • Singleton pregnancy • Cephalic presentation • Vaginal delivery is not contraindicated • Spontaneous labour • Nulliparous • Multiparous • No history of any previous uterine surgery • Mentally fit • In the latent phase of the first stage of labour • No surgical indication at the time of study beginning • Stature ≥150 cm. • Pregnancy complicated with anaemia, pregnancy-induced hypertension, diabetes, and fetal congenital malformations • Grand parity (para five or more) • History of previous assisted vaginal delivery • Have more than 5 years from the last delivery • Who will refuse to participate Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 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 30/05/2023 Institutional Research Review Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Iyumbu Dodoma 0000 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of second stage, incidence of composite adverse maternal outcomes such as perineal tears, postpartum haemorrhage, Caesarean Section (C/S), assisted vaginal deliveries, episiotomies and shoulder dystocia and adverse neonatal outcomes such as low 5 minute APGAR score, resuscitation, and admission to New-Born Unit. Second stage of labour.
Secondary Outcome Patients’ perceptions of the birth experience and Healthcare providers’ perceptions of the birth positions. Immediate Postnatal Period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Muhimbili National Hospital Maliki Road Dar es Salaam 0000 United Republic of Tanzania
Muhimbili Mloganzila Hospital Kibamba Road Dar es Salaam 0000 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Sospeter Mkangi Iyumbu Dodoma 0000 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sospeter Mkangi Iyumbu Dodoma 0000 United Republic of Tanzania Individual
COLLABORATORS
Name Street address City Postal code Country
Saada Ali Iyumbu Dodoma 0000 United Republic of Tanzania
Rehema Bakari Iyumbu Dodoma 0000 United Republic of Tanzania
Aisha Tambwe Iyumbu Dodoma 0000 United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sospeter Mkangi sosymkangi@gmail.com +255744139100 Iyumbu
City Postal code Country Position/Affiliation
Dodoma 0000 United Republic of Tanzania The University of Dodoma
Role Name Email Phone Street address
Public Enquiries Saada Ali saadudat@gmail.com +255776929789 Iyumbu
City Postal code Country Position/Affiliation
Dodoma 0000 United Republic of Tanzania The University of Dodoma
Role Name Email Phone Street address
Scientific Enquiries Rehema Bakari rehema2207@gmail.com +255758417115 Iyumbu
City Postal code Country Position/Affiliation
Dodoma 0000 United Republic of Tanzania The University of Dodoma
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I intend to share all of the individual participant data collected during the trial after deidentification along with the study protocol, statistical analysis plan, informed consent form and clinical study report immediately following publication with University of Dodoma, Muhimbili National Hospital, Muhimbili Mloganzila Hospital, Institutional Research Review Ethics Committee, Publication and Journal and Pan African Clinical Trial Registry. The proposal for data accessibility should be directed to rehema2207@gmail.com whereas the requestors will need to sign a data access agreement. Informed Consent Form,Study Protocol 2 years Open Acces
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