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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202110569676541 Date of Registration: 18/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title NORMAL-SALINE VERSUS DEXTROSE-SALINE FOR OXYTOCIN INFUSION DURING INDUCTION OF LABOUR: RANDOMISED CONTROLLED STUDY COMPARING LABOUR DURATION AND FETO-MATERNAL METABOLIC PARAMETERS.
Official scientific title NORMAL-SALINE VERSUS DEXTROSE-SALINE FOR OXYTOCIN INFUSION DURING INDUCTION OF LABOUR: RANDOMISED CONTROLLED STUDY COMPARING LABOUR DURATION AND FETO-MATERNAL METABOLIC PARAMETERS.
Brief summary describing the background and objectives of the trial Background Induction of labour is a common obstetric procedure that has been shown to reduce the rate of caesarean section. Recent research findings have demonstrated that glucose is the major energy substrate for the uterus in labour and there is some evidence that delivery of oxytocin in dextrose saline may confer benefit of shortening the duration of labour. These studies were mainly in non-black population and no such study has been done in UITH Ilorin. Aim The aim of this study is to determine the duration of labour in parturient that had oxytocin administration via 5%dextrose in 0.9% normal saline and compare to the duration in those that had it in 0.9% normal saline in UITH Ilorin. The effect of each fluid on maternal and cord blood lactate as well as maternal sodium will also be assessed. Methods The study shall be a randomized controlled trial involving pregnant women planned for induction of labour with oxytocin at the department of Obstetrics and Gynaecology University of Ilorin Teaching Hospital, Ilorin. At presentation feto-maternal assessment will be done to rule out contraindications. Vaginal examination will be done and Bishop’s score assigned. Seventy-eight induction of labour packs each containing 3 bags of 500mls intravenous fluids (JUHEL Pharmaceuticals limited) will be used for the study. Thirty nine of the packs will contain normal saline and the other 39 will contain dextrose saline. The fluids in each pack will be stripped of their labels and each pack will be randomly assigned numbers from 1 to 78. Each pack of fluid will then be added to the ‘induction pack’. After patients have been adjudged to have a favourable cervix, they will be assigned the induction packs with the lowest number on its label. Recruitment will follow sequentially until 78 patients are recruited. Sample for maternal baseline lactate and sodium will be obtained just before commencement of oxytocin infusion. Intrapartum fetal monitoring will be done according to departmental protocol noting the duration of first stage of labour, second stage of labour as well as the third stage. Cord blood lactate will also be obtained as well as maternal post-delivery lactate and sodium after delivery of the baby. Primary outcome measures will be the duration of labour from commencement of oxytocin to delivery of placenta. The secondary outcomes will be neonatal cord lactate level, maternal plasma lactate difference and maternal plasma sodium difference. The outcome measures will be compared between the study groups using SPSS version 23. Chi square at significant level of 0.05 and confidence level of 95% shall be used to determine significance.
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 Treatment: Drugs
Anticipated trial start date 15/07/2020
Actual trial start date 15/09/2020
Anticipated date of last follow up 10/01/2020
Actual Last follow-up date 17/06/2021
Anticipated target sample size (number of participants) 78
Actual target sample size (number of participants) 78
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 Numbered containers Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oxytocin administration in Dextrose saline Titration against uterine contraction From Bishop's score of 9 till delivery of the placenta Administration of oxytocin in 5% dextrose saline during induction of labour 39
Control Group Administration of oxytocin in 0.9 Normal saline Titration against uterine contraction From Bishop's score of 9 till delivery of placenta Oxytocin is administered for induction of labour through Normal saline 39 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Pregnant women with singleton fetus at term (37 to 42weeks) in cephalic presentation. • Patients planned for induction of labour using oxytocin infusion • Evidence of live fetus with intact fetal membranes. • Ultrasound estimated fetal weight of <4000g at the time of recruitment. • Modified Bishop score ≥6 at the time of commencing oxytocin infusion. (In patients with unfavorable cervix, cervical ripening will be done with the use of intracervical extramniotic Foley catheter). • Non consenting patients. • Women with pre-gestational or gestational diabetes mellitus. • Clinical evidence of chorioamnionitis • Parturients with previous uterine surgery (caesarean section, myomectomy and metroplasty). • Intrauterine fetal death. • Premature rupture of fetal membranes. • Women with any contraindication to vaginal delivery Adult: 18 Year(s)-44 Year(s) 18 Year(s) 50 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 26/11/2019 University of Ilorin Teaching Hospital Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Oke-Ose Ilorin 240003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome would be the duration of labor from the time of commencement of oxytocin infusion to the time of delivery of the placenta. After the delivery of the placenta
Secondary Outcome The secondary outcomes will include neonatal cord blood lactate and the maternal plasma sodium and lactate difference. After the delivery of the placenta
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ilorin Teaching Hospital Oke-Ose Ilorin Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Ilorin Teaching Hospital AND Dr Afusat Olabinjo UITH, Oke Ose Ilorin Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Afusat Olabinjo No 8, Etsu Ndakpoto Street, Basin Ilorin Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Afusat Olabinjo hafsoh.ola@gmail.com +2348062164990 No 8, Etsu Ndakpoto street, Basin
City Postal code Country Position/Affiliation
Ilorin Nigeria Resident Doctor
Role Name Email Phone Street address
Public Enquiries Adebunmi Olarinoye adebunmiolarinoye@yahoo.com +2348033975764 Deoartment of Obstetrics and Gynaecolgy UITH
City Postal code Country Position/Affiliation
Ilorin Nigeria Senior Lecturer Department of Obstetrics and Gynaecology University of Ilorin Teaching Hospital Ilorin
Role Name Email Phone Street address
Scientific Enquiries Abiodun Adeniran acrowncord@hotmail.com +2348057334788 Department of Obstetrics and Gynaecology, University of Ilorin Teaching Hospital
City Postal code Country Position/Affiliation
Ilorin Nigeria Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual deidentified data that underlie the results presented in the publication - text, figures, tables and appendices. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 3 years after publication of the article Controlled - researchers who provide a methodologically sound proposal.
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