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.: PACTR202311852717227 Date of Approval: 30/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of drotaverine hydrochloride in reducing duration of labour in term pregnancies at Nnamdi Azikiwe University Teaching Hospital, Nnewi: a double-blind randomised controlled study
Official scientific title Efficacy of drotaverine hydrochloride in reducing duration of labour in term pregnancies at NAUTH, Nnewi: a double-blind randomised controlled study
Brief summary describing the background and objectives of the trial Background The process of labour is met with several morbid states to both the mother and fetus especially if prolonged, such as postpartum haemorrhage, dehydration, higher admissions into the neonatal intensive care unit and ultimately maternal and fetal mortality. Thus, reducing the duration of labour is essential in preventing this. Drotaverine hydrochloride, a potent spasmolytic has been found to reduce the duration of labour in other regions, thus meriting evaluation of its use in labour in our setting. Objective The study is mapped out to assess the efficacy of intravenous drotaverine hydrochloride in reducing the duration of labour in term pregnancies and other maternal and fetal effects.
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 Effect on duration of labour
Purpose of the trial efficacy in reducing duration of labour
Anticipated trial start date 04/12/2023
Actual trial start date
Anticipated date of last follow up 18/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 128
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Drotaverine Hydrochloride single dose of 40mg (2ml) given intravenously stat dose Once in the active phase of labour (4-5cm) one arm will receive a single dose of 40mg intravenous drotaverine hydrochloride 64
Control Group Diluted Vitamin B complex single dose of the constituted placebo stat dose The control group will receive the constituted placebo once in active phase (4-5cm) of labour. The placebo is constituted by adding 0.5ml of vitamin B complex into 9.5ml of sterile water for injection, from this, 2ml will be withdrawn and kept. This is to ensure that the intervention drug and the placebo drug are of the same colour, thus participants and research assistants are properly blinded to avoid bias. 64 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Term pregnancies 2. Women with foetus in cephalic presentation 3. Women with a singleton pregnancy 4. Cervical dilatation of 4-5cm only 1. Women with a previous history of cervical surgery or trauma 2. Women with contraindications to vaginal delivery 3. Women with medical disease in pregnancy 4. Women with known hypersensitivity to Drotaverine hydrochloride 5. Women less than 18 years Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 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 22/12/2022 NAUTH Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Nnamdi Azikiwe University teaching Hospital nnewi Nnewi 5025 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome duration of the active phase of labour. at completion of the active phase of labour
Secondary Outcome - need for augmentation of labour - duration of second stage labour - duration of third stage of labour at the completion of the third stage of labour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi Nnewi Onitsha Old Road Nnewi Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SELF Nnamdi Azikiwe University Teaching Hospital Nnewi 5025 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Obinna Carl Okafor Nnamdi Azikiwe University Teaching Hospital Nnewi 5025 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Chimezie Madunatu Namdi Azikiwe University Teaching Hospital Nnewi Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Obinna Okafor obinix@yahoo.com +2347036333049 Nnamdi Azikiwe University Teaching Hospital
City Postal code Country Position/Affiliation
Nnewi Nigeria Senior Resident
Role Name Email Phone Street address
Public Enquiries Echezona Onyekwelu onyekwelu_echezona@yahoo.com +2348064862997 Nnamdi Azikiwe University teaching Hospital
City Postal code Country Position/Affiliation
Nnewi Nigeria Senior Resident
Role Name Email Phone Street address
Scientific Enquiries Chidimma Okafor cmbaegbu@gmail.com +2347038680843 5b Rock Foundation Street
City Postal code Country Position/Affiliation
Onitsha Nigeria Pharmacist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant data summary results all of the individual participant data collected during the trial after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol October 2024 to February 2025 Open
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