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.: PACTR201810902005232 Date of Registration: 11/10/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Drotaverine HCL in reducing the duration of first stage of labour among nulliparous women at Federal Teaching Hospital, Abakaliki.
Official scientific title Effectiveness of Drotaverine HCL in reducing the duration of first stage of labour among nulliparous women at Federal Teaching Hospital, Abakaliki.
Brief summary describing the background and objectives of the trial Prolonged labour is a complication of labour that can cause morbidity and mortality especially among nulliparous women. Achieving a reduction in the duration of labur in the background of active management of labour is a desirable outcome as prolonged labour frequently results in maternal infection and exhaustion and other long term sequelae. This study aims to determine if Drotaverine HCL can reduce the duration of labour compared with placebo, to determine if drotaverine HCL can reduce pain in labour compared with placebo, to determine side effects if any with drotaverine HCL use compared with placebo.
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 04/04/2018
Actual trial start date 07/05/2018
Anticipated date of last follow up 01/09/2018
Actual Last follow-up date 03/09/2018
Anticipated target sample size (number of participants) 220
Actual target sample size (number of participants) 216
Recruitment status Closed to recruitment,follow-up continuing
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Drotaverine 40mg single dose Single dose over 5-10 minutes Drotaverine is a spasmolytic agent 110
Control Group Placebo 2ml Single dose over 5minutes Vit BCO 110 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Nullipara or primigravida Cervical dilation of 4-5cm only Consent No prior use of spasmolytics Term PROM Coexisting masses Allergy to Drotaverine HCL Multipara Postdatism Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 49 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 05/09/2017 Research and ethics committee Federal Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Abakaliki Abakaliki 00480 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of first stage of labour At diagnosis of active phase of labour/ injection of drug or placebo and at full cervical diagnosis
Secondary Outcome Pain, mode of delivery, maternal sideeffects, APGAR score at 1st and 5th minute, need for augmentation of abour At admisson, 30 minutes into recruitment, 60 minutes into recruitment, 2 hours into recruitment and at birth of the baby
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Teachuing Hospital Abakaliki Abakaliki 00480 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ikeotuonye Arinze No 18 Fide Ogodo street Abakaliki 00480 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ikeotuonye Arinze No 18 Fide Ogodo street Abakaliki 00480 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Arinze Ikeotuonye arinze790@gmail.com +2348038730293 Federal Teaching Hospital
City Postal code Country Position/Affiliation
ABAKALIKI 00480 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Odidika Umeora oujair@yahoomail.com +2348039558074 Federal Teaching Hospital
City Postal code Country Position/Affiliation
Abakaliki 00480 Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries Arinze Ikeotuonye arinze790@gmail.com +2348038730293 Federal Teaching hospital
City Postal code Country Position/Affiliation
Abakaliki 00480 Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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