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.: PACTR202111520130772 Date of Approval: 29/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Hyoscine-N-Butylbromide for the shortening of the Active Phase of Labour in Primigravidae: A Double Blind Randomized Placebo Controlled Trial at the University Of Uyo Teaching Hospital, Akwa-Ibom State, Nigeria
Official scientific title Hyoscine-N-Butylbromide for the shortening of the Active Phase of Labour in Primigravidae: A Double Blind Randomized Placebo Controlled Trial at the University Of Uyo Teaching Hospital, Akwa-Ibom State, Nigeria
Brief summary describing the background and objectives of the trial BACKGROUND: Labour in a primigravid woman is fraught with obstetric risks and complications ranging from labour Dystocia to operative deliveries and increased rate of neonatal intensive care admission. This is further worsened in the background of low socioeconomic status and poor antenatal care seeking behaviour prevalent in the region of study. AIMS AND OBJECTIVES: This study seeks to evaluate the effectiveness of intramuscular hyoscine-n-butylbromide in shortening the active phase of labour including its effect on the maternal and foetal outcome in primigravidae in the University of Uyo Teaching Hospital, south-south Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) proposal phase
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 22/11/2021
Actual trial start date
Anticipated date of last follow up 21/06/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status 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 a randomization table created by a computer software program Sealed opaque envelopes 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 hyoscinenbutylbromide intramuscular, 40mg one off intramuscular hyoscine-n-butylbromide 40mg 50
Control Group water for injection 2 mililitres one off intramuscular water for injection 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a. First time pregnant mothers b. Aged 20-35 years c. Gestational age of 37 to 41 weeks d. Singleton foetus in cephalic presentation e. Spontaneous onset of labour. f. Active phase labour(cervical dilatation of 5cm to 7cm) g. Spontaneous rupture of membranes < 2hours a. Maternal age below 20 and above 35 years b. Referred and unbooked mothers c. Multiple pregnancies d. Previous uterine scar e. Foetal Malpresentation f. Antepartum haemorrhage g. Induced labour h. Rupture of foetal membranes (>2 hours) i. Contraindications to vaginal delivery, j. Mothers on cervical cerclage, k. Maternal pyrexia and l. Allergy to HBB m. Co-morbidities like pre-eclampsia, cardiac, renal and liver disorders, asthma, sicklers, epilepsy, hypertension and diabetes mellitus n. History of infertility. o. Absolute contraindications to HBB like paralytic ileus, intestinal obstruction, myasthenia gravis, mechanical gastrointestinal tract stenosis p. Down’s syndrome q. Hyperthyroidism r. Heart failure s. Gastro-oesophageal reflux disease (GERD) t. Urinary incontinence u. Severe constipation v. Untreated narrow angle glaucoma w. Allergy to belladonna alkaloids x. Megacolon/Hirschsprung’s disease y. Prostatic hypertrophy with urinary retention 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 28/06/2021 UNIVERSITY OF UYO TEACHING HOSPITAL UYO INSTITUTIONAL HEALTH RESEARCH ETHICAL COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Abak road Uyo 5201 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome duration of active phase of labour full cervical dilatation
Secondary Outcome duration of second and third stage of labour, analgesic effect, maternal side effects, Caesarean section rate, cervical laceration rate, estimated blood loss post delivery, fetal outcome delivery of baby, delivery of placenta, made of delivery,
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Uyo Teaching Hospital south south Nigeria Abak road Uyo 5201 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded Ikot Ntuen Nsit, Nsit Ubiom, Akwa-Ibom state Uyo 5201 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR ANIEKAN JACKSON IKOT NTUEN NSIT, NSIT UBIOM, AKWA-IBOM STATE UYO 5201 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ANIEKAN JACKSON jacksonaniekan@yahoo.com 2348063430018 Abak road
City Postal code Country Position/Affiliation
Uyo 5201 Nigeria Principal Researcher
Role Name Email Phone Street address
Scientific Enquiries SATURDAY ETUK imaetuks345@yahoo.com 2348033172687 Abak road
City Postal code Country Position/Affiliation
Uyo 5201 Nigeria Supervisor
Role Name Email Phone Street address
Scientific Enquiries EMMANUEL INYANGETOH emmacol2012@gmail.com 2348033452822 Abak road
City Postal code Country Position/Affiliation
Uyo 5201 Nigeria Supervisor
Role Name Email Phone Street address
Public Enquiries NSIKAK NYOYOKO nsikokobest@gmail.com 2348037081997 Abak road
City Postal code Country Position/Affiliation
Uyo 5201 Nigeria professional consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes participants identities will be concealed and will be expressed in serial numbers associated with the initials of their names Informed Consent Form,Statistical Analysis Plan,Study Protocol within a year of completion of study open access
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