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.: PACTR201805003364421 Date of Approval: 02/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Bicarbonate in Obstructed Labour
Official scientific title Effect of preoperative bicarbonate infusion on Maternal and Perinatal outcomes of obstructed labour; A study protocol for a Randomised Controlled Trial
Brief summary describing the background and objectives of the trial In low resource setting like Uganda, obstructed labour(OL) is still a common problem. It causes significant maternal and perinatal morbidity and mortality because many patients reach late at the tertiary health facility. It is associated with electrolyte and metabolic changes, which have been implicated in the aetiology adverse outcome like birth asphyxia and primary postpartum haemorrhage due to uterine atony. In addition, OL is common indication for operative delivery either by primary emergency cesarean section (90%) or assisted vaginal delivery (10%)it is a common indication for primary emergency cesarean section to achieve a safe child birth for both mother and baby. Fluid replacement during preoperative period corrects the electrolyte changes and dehydration associated with OL, but it probably doesn¿t completely reverse the associated metabolic acidosis. Sodium bicarbonate is a safe, effective, cheap and readily available acid buffer that is widely used by sportsmen to improve performance. It also improves maternal fetal outcomes in abnormally progressing labour by favorably altering the intrauterine conditions. Its effect on foetal maternal outcomes among patients with OL is unknown. We aim to establish the effect of a preoperative bicarbonate infusion on maternal and perinatal outcomes among patients with OL in Mbale Regional Referral Hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstructed Labour,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 04/06/2018
Actual trial start date
Anticipated date of last follow up 31/07/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 308
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 Permuted block randomisation by an independent statistician using block sizes of 4,6&8 Numbered study drug bottles Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pre-operative Sodium Bicarbonate infusion (4.2g/50mEq of an 8.4% solution) single dose over 5-10 minutes In addition to the standard pre-operative fluid replacement 154
Control Group Only standard preoperative care 1.5 liters of Normal Saline 15-30 minutes Current standard for preoperative fluid replacement in obstructed labour 154 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Have a singleton pregnancy 2.Gestation age of at least 37 weeks 3. Cephalic presentation 4. A live baby. 1. Those with other obstetric conditions like APH, PE/E, PROM and IUFD 2. Those with other commodities like DM, SCD & heart disease 3. Those who are unable to give informed consent 4. Are not willing to be followed up to the end of the study 5. Those with hypernatraemia at baseline (> 148mEq/L) 6. Those with alkalosis at baseline (> 22mEq/L) 15 Year(s) 49 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
No 19/04/2018 School of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Makerere University College of Health Sciences Kampala P.O Box7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Maternal, mean lactate in capillary blood at one hour after onset of study drug administration At baseline and at one hour after onset of study drug administration
Primary Outcome Newborn, arterial cord blood lactate at birth (Foetal acidosis) Within one minute of child birth
Secondary Outcome venous cord blood lactate Within one minute of child birth
Secondary Outcome Apgar score At one and five minutes after birth
Secondary Outcome Admission to NICU Up 7th day after birth
Secondary Outcome Perinatal death Up to 7th day after birth
Secondary Outcome Neonatal sepsis Up to 7th day after birth
Secondary Outcome Myometrial Lactate Intraoperatively
Secondary Outcome Primary postpartum haemorrhage Within 24 hours of child birth
Secondary Outcome Birth canal trauma Immediately after child birth
Secondary Outcome Duration of hospital stay At discharge
Secondary Outcome Puerperal sepsis Up to the 14th day after child birth
Secondary Outcome Fistulae Up to the 14th day after child health
Secondary Outcome Duration of hospital stay Up to the time of discharge
Secondary Outcome Puerperal sepsis Up to the 14th day after child birth
Secondary Outcome Obstetric fistulae Up to the 14th day after child birth
Secondary Outcome Death Up to the 14th day after child birth
Secondary Outcome Death Up to the 14th day after child birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbale Regional Referral & Teaching Hospital Pallisa Rod Mbale P.O Box 921 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Survival Pluss project (no. UGA-13-0030) funded under NORHED by NORAD; Norway Makerere University College of Health Sciences Kampala P.O Box 7072 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Makerere University P.O Box 7072 Kampala Uganda University
Secondary Sponsor Busitema University Faculty of Health Sciences Pallisa Rod Mbale P.O Box 1460 Uganda University
COLLABORATORS
Name Street address City Postal code Country
Prof. Julius N. Wandabwa Busitema University Faculty of Health Sciences Mbale P.O Box 1460 Uganda
Prof. Grace Ndeezi Makerere University College of Health Sciences Kampala P.O Box 7072 Uganda
Dr. Justus K Barageine Makerere University College of Health Sciences Kampala P.O Box 7072 Uganda
Prof. Andrew D. Weeks Professor of International Maternal Health Sanyu Research Unit University of LiverpoolL87SS Liverpool Crown Street United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Milton Musaba miltonmusaba@gmail.com +256704913791 Pallisa Road
City Postal code Country Position/Affiliation
Mbale P.O box 380 Mbale Uganda Obstetrician&Gynaecologist
Role Name Email Phone Street address
Public Enquiries Milton Musaba miltonmusaba@gmail.com +256704913791 Pallisa Road
City Postal code Country Position/Affiliation
Mbale P.O box 380 Mbale Uganda Obstetrician&Gynaecologist
Role Name Email Phone Street address
Scientific Enquiries Milton Musaba miltonmusaba@gmail.com +256704913791 Pallisa Road
City Postal code Country Position/Affiliation
Mbale P.O box 380 Mbale Uganda Obstetrician&Gynaecologist
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information