Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202402717378543 Date of Registration: 21/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of Hyoscine butyl bromide on the duration of the first stage of labour in nulliparous women: A randomised controlled trial in Wuse District Hospital, Abuja.
Official scientific title The effect of Hyoscine butyl bromide on the duration of the first stage of labour in nulliparous women: A randomised controlled trial in Wuse District Hospital, Abuja.
Brief summary describing the background and objectives of the trial Prolonged labour is associated with maternal and perinatal morbidity and mortality including increased risk of maternal haemorrhage, puerperal sepsis and increased rate of obstetric interventions. This may result from intrinsic factors affecting the cervix leading to poor cervical dilatation or result from mechanical obstruction. Prolonged labour in nulliparous women is due mainly to inefficient uterine action and failure of cervical dilatation. Agents that can accelerate the rate of cervical acceleration will reduce the morbidity and mortality associated with prolonged labour among other factors. This has led to studies on various agents that can be used to accelerate the rate of cervical dilatation with subsequent reduction in the duration of labour, thus preventing prolonged labour. The aim of the study is to determine the effect of Hyoscine Butyl Bromide (HBB) on the duration of the first stage of labour in nulliparous women in Wuse District Hospital, Abuja
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 01/10/2022
Actual trial start date 01/01/2023
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date 31/08/2023
Anticipated target sample size (number of participants) 136
Actual target sample size (number of participants) 136
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
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group HYOSCINE BUTYL BROMIDE 20MG SINGLE INTRAMUSCULAR DOSE AT ONSET OF ACTIVE PHASE OF LABOUR WHICH IS 4CM CERVICAL DILATATION, 20MG OF HYOSCINE IS GIVEN AS AN INTRAMUSCULAR INJECTION TO THE STUDY GROUP AND PRIMARY AND OUTCOME MEASURES MONITORED 68
Control Group 1ML OF STERILE WATER 1ML OF STERILE WATER STAT AS INTRAMUSCULAR INJECTION SINGLE INTRAMUSCULAR INJECTION 1ML OF STERILE WATER GIVEN TO THE CONTROL GROUP AT ONSET OF ACTIVE PHASE OF LABOUR WHICH IS 4CM CERVICAL DILATATION 68 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1 Inclusion Criteria i. Nulliparous Parturients in active phase of labour (cervical dilatation of 4cm) ii. Patients who gave informed consent to the study. iii. Term Gestation (37 completed - 42 weeks) iv. Singleton pregnancy in cephalic presentation v. Absence of contraindication to vaginal delivery vi. Spontaneous labour 2 Exclusion Criteria i. Patients with uterine scar ii. Patients with fetal malpresentation iii. Patients with Chronic hypertension, Pre-gestational Diabetes, Gestational diabetes, Pregnancy induced hypertension or Preeclampsia iv. Multiple gestation v. Multiparous patients vi. Hypersensitivity to Hyoscine vii. Contraindications to vaginal delivery Adult: 19 Year-44 Year 18 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 05/09/2022 FEDERAL CAPITAL TERRITORY HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
1 KAPITAL STREET 11, GARKI, ABUJA ABUJA 900247 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure was the duration of the first stage of labour. 2 HOURLY FROM 4CM CERVICAL DILATATION TO 8CM AND THEREAFTER 1 HOURLY TILL FULL CERVICAL DILATATION
Secondary Outcome The secondary outcome measures were the duration of the second and third stages of labour, maternal drug side effects, Apgar scores of the neonates and need for neonatal admission. FROM ONSET TO COMPLETION, APGAR SORE-1ST AND 5TH MINUTES AFTER BIRTH
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
WUSE DISTRICT HOSPITAL ABUJA NO 15 CONAKRY STREET, WUSE ZONE 3, FCT, ABUJA ABUJA 904101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SELF FUNDED HOUSE 2, ROAD C2, PENTVILLE ESTATE, LOKOGOMA, ABUJA ABUJA 900107 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR. YIBALA EDIMEK HOUSE 2, ROAD C2, PENTVILLE ESTATE, LOKOGOMA, ABUJA ABUJA 900107 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator YIBALA EDIMEK yibiakpama@yahoo.com +2348063922919 HOUSE 2, ROAD C2, PENTVILLE ESTATE, LOKOGOMA, ABUJA
City Postal code Country Position/Affiliation
ABUJA 900107 Nigeria SENIOR REGISTRAR FCTA HOSPITALS
Role Name Email Phone Street address
Public Enquiries JOYCE EZEUGO joyce_chychy@yahoo.com +2348039484764 15 CONAKRY STREET, WUSE ZONE 3, ABUJA
City Postal code Country Position/Affiliation
ABUJA 900283 Nigeria CONSULTANT FCTA HOSPITALS
Role Name Email Phone Street address
Public Enquiries JONATHAN EDIMEK jonathan.edimek@yahoo.com +2348037268189 HOUSE 2, ROAD C2, PENTVILLE ESTATE, LOKOGOMA, ABUJA
City Postal code Country Position/Affiliation
ABUJA 900107 Nigeria MEDICAL DOCTOR
Role Name Email Phone Street address
Scientific Enquiries FRANCIS ALU drfrankalu@yahoo.com +2348037206243 NO 31 JULIUS NYERERE CRESCENT, ASOKORO, ABUJA
City Postal code Country Position/Affiliation
ABUJA 900231 Nigeria CONSULTANT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes, individual participants data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices). Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 YEAR CONTROLLED
URL Results Available Results Summary Result Posting Date First Journal Publication Date
NOT AVAILABLE YET Yes 16/02/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/02/2024 Result - 16/02/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information