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.: PACTR202407805328722 Date of Approval: 29/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title study on the effect of hyoscine on progress of labour and pregnancy outcome
Official scientific title Effect of hyoscine N-Butyl bromide on progress of labour and pregnancy outcome; A randomized control trial
Brief summary describing the background and objectives of the trial Labour is a physiological process during which the fetus, membranes, umbilical cord and placenta are expelled from the uterus. uterine contraction and cervical dilation are important factor that determines duration of labour and the duration of labor is one of the effective factors in maternal and fetal outcomes. Prolonged labour is an important risk factor for both maternal morbidity and perinatal compromise which can lead to uterine rupture, postpartum hemorrhage, puerperal sepsis, neonatal asphyxia and maternal or fetal death therefore minimizing the duration of labour without compromising fetomaternal wellbeing is a desirable outcome in all labour and delivery units Hyoscine –N- Butyl Bromide is a semisynthetic derivative compound of belladonna alkaloid which was a derivative from a shrub (Dubosia) found in Australia. Hyoscine –N- butyl bromide helps smoothen the passage of labour by shortening the duration of active phase of first stage of labour without any foeto-maternal effects. Objectives of the study i. To determine the effect of hyoscine N-butylbromide versus placebo on cervical dilatation during labour. ii. To examine the effect of single dose of 20mg hyoscine butylbromide on the progress of first stage of labour. iii. To examine the effect of 20mg hyoscine butylbromide on the progress of second stage of labour. iv. To examine the effect of hyoscine butylbromide on the progress of third stage of labour. v. To determine the effect of hyoscine butyl bromide on maternal and fetal outcomes of pregnancy. vi. To determine the relationship between primigravida and multigravida and the effect of hyoscine butylbromide on the progress and outcome of labour.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied labour progress
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2023
Actual trial start date 08/11/2023
Anticipated date of last follow up 10/02/2024
Actual Last follow-up date 26/02/2024
Anticipated target sample size (number of participants) 128
Actual target sample size (number of participants) 128
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NHREC172018 Health Research Ethics Committee, Ministry of Health Kano
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 hyoscine butylbromide and water for injection 20mg single dose slowly intravenously Hyoscine-N-butylbromide is also called Scopolamine-N-Butylbromide, N Butylscopolammonium Bromide, and butylscopolamine. It is a semisynthetic derivative of scopolamine. After intravenous administration, the hyoscine butylbromide is rapidly distributed into the tissues (t½ = 29 min), 10 minutes onset of action after intravenous dosing with peak effect seen at 20-60 minutes and action lasts for two to four hours. Hyoscine butylbromide is in use in varying doses (20, 30mg, 40mg) and various routes of administration (intramuscular, intravenous, rectal, oral). Intravenous route is of advantage because it can be given in a controlled manner (slow IV over 1-2 minutes) are its rapid onset of action and bypass of hepatic metabolism. 64
Control Group water for injection 2mls single dose intravenously slowly water for injection is water of extra high quality without significant contamination, it has no active properties. 64 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Pregnant women with term pregnancy gravida 1 to gravida 5 2. Those that consented to partake in the study 3. Aged 18 and above 4. Women in active phase of labour 5. Women with no contraindication to drug use 6. Singleton foetus at term 7. Cephalic presentation 1. Women with contraindication to vaginal delivery 2. Women with any present or past obstetric emergency/complication 3. Intrauterine fetal Death (IUFD) 4. Fully dilated 5. Suspected fetal distress Adult: 19 Year-44 Year 18 Year(s) 40 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 11/09/2023 Kano State Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
2nd and 3rd floor, post office road kano PMB.3066 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcomes that will be noticed are the duration of first, second and third stages of labour, cervical dilation rate, the maternal and neonatal side effects. Secondary outcome are postpartum hemorrhage rate, uterine inertia, caesarean section rate, tachycardia and the relationship between the parity of the respondent. During active phase of labour and immediately after birth
Secondary Outcome postpartum hemorrhage rate, uterine inertia and caesarean section rate. during active labour and after delivery of the fetus
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sheikh MUhammad Jidda General Hospital Kano Murtala Muhammad Way Kano Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Rahmat Adamu 226/227 hausawa layout kano Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rahmat Adamu 226/227 Hausawa layout Kano Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rahmat Adamu biintadam@gmail.com +2348069551029 226/227 Hausawa Layout
City Postal code Country Position/Affiliation
Kano Nigeria principal investigator
Role Name Email Phone Street address
Scientific Enquiries Abdullahi Haruna Ibrahim ahibrahim.nur@buk.edu.ng +2348035570017 Hospital Road, Darmanawa
City Postal code Country Position/Affiliation
Kano Nigeria Scientific enquiries
Role Name Email Phone Street address
Public Enquiries Muhammad Kabir Bello drkaybee2013@gmail.com +2348038110845 Hospital road
City Postal code Country Position/Affiliation
Kano Nigeria public enquiries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The purpose of this study is to examine the effects of hyoscine N- butylbromide on progress of labour and pregnancy outcome. All of the individual participant data collected during the trial after de identification such as text, tables, figures, informed consent and appendices will be made available immediately after publication. Anyone who wishes to access the data can do so. Informed Consent Form 15 month after being published
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