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.: PACTR201412000911878 Date of Approval: 19/10/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Upright posture and uterine fundal pressure during second stage of labour: A Randomized control trial
Official scientific title Upright posture and uterine fundal pressure during second stage of labour: A Randomized control trial
Brief summary describing the background and objectives of the trial This is a randomized controlled trial to evaluate the adoption of an upright posture or the application of uterine fundal pressure against the use of routine semi-supine position used during second stage of labour on reducing the amount of post partum haemorrhage during the third and second stage of labour and other foetal, maternal and neonatal adverse events in nulliparous women who gave birth in public hospitals in selected sites in Nigeria and South Africa.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postpartum haemorrhage,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 26/11/2014
Actual trial start date
Anticipated date of last follow up 20/10/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 1839
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 sequence generated by a computer software program stata Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group semi-supine with uterine fundal pressure 30-40 seconds during each bearing down effort the mother adapts a semi-supine posture during the active phase of second stage of labour, while the doula her forearm only placed across the abdomen and apply gentle fundal pressure in the direction of the cervical opening. She stop once the uterine contractions are over (40-60 seconds) 613 Active-Treatment of Control Group
Experimental Group upright posture as convenient less than 30 minutes Mother adapts an upright posture in later stage of second stage of labour. The upright posture could be squatting, sitting, kneeling and maintain the posture as convenient until expulsion of the fetus 613
Control Group control group standard of care standard care routine care as offered in the 613
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
18 years and older nulliparous uncomplicated singleton pregnancy (low risk clients for midwives) between 37-41 completed weeks gestation anticipated normal vertex delivery cervix less than 7 cm dilated sensitized during antenatal visit read, understand informed consent and sign informed consent give informed consent in first stage labour medical contraindication to vagina delivery surgical contraindication to vaginal birth Hemoglobin less than 7g/dl 18 Year(s) 46 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 23/09/2014 University of Fort Hare University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
King Williams Road Alice 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postpartum haemorrhage third stage of labour fourth stage of labour
Secondary Outcome duration of second stage from full dilation of cervix with bearing down to the expulsion of the feotus
Secondary Outcome admission to scbu after delivery
Secondary Outcome apgar score at 0 and 5 minutes
Secondary Outcome perineal trauma after delivery
Secondary Outcome foetal outcome birth weight birth length head circumference Apgar score infant resuscitqtion infant cord blood
Secondary Outcome mother outcom mother status blood loss weight PCV/Hb discharge
Secondary Outcome foetal outcome Birth Weight Infant Birth Length Head Circumference APGAR Score Infant Resuscitation infant Cord Blood
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bisho Provincial Hospital R 63 Road Bhisho 5605 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Self no 6 Radcliff crescent, Highway Gardens East London 5201 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amwe Aku 116 Belligan Crescent, Winterstrand East London 5208 South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Prof Cheryl Nikodem University of Fort Hare, 50 Church Street East London 5201 South Africa
Mandisa Singata East London 5201 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amwe Aku sundayaku@gmail.com +2348170628763 116 Belligan Crescent, Winterstrand
City Postal code Country Position/Affiliation
East London 5208 South Africa
Role Name Email Phone Street address
Public Enquiries Amwe Aku sundayaku@gmail.com +2348170628763 116 Belligan Crescent, Winterstrand
City Postal code Country Position/Affiliation
East London 5208 South Africa
Role Name Email Phone Street address
Scientific Enquiries Amwe Aku sundayaku@gmail.com +2348170628763 116 Belligan Crescent, Winterstrand
City Postal code Country Position/Affiliation
East London 5208 South Africa
REPORTING
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Result URL Hyperlinks
Changes to trial information