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.: PACTR201803003208333 Date of Approval: 18/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A randomised double blind placebo controlled study on the effect of intramuscular hyoscine butylbromide and drotaverine in the first stage of active p
Official scientific title A randomised double blind placebo controlled study on the effect of intramuscular hyoscine butylbromide and drotaverine in the first stage of active phase of labour on labour and delivery outcome
Brief summary describing the background and objectives of the trial Prolonged labour can lead to high rate of maternal and neonatal morbidity and mortality due to an increased risk of maternal sepsis, foetal distress, birth asphyxia and postpartum haemorrhage. Prevention and ensuring appropriate clinical response is required to mitigate against complications which is especially more in low resource setting. Medical intervention such as the administration of antispasmodic agents has been used as a preventive or a treatment strategy in order to shorten the course of labour and decrease the incidence of prolonged labour. The mechanism by which it acts in the context of labour has not yet been fully elucidated, and the evidence for its efficacy has been largely anecdotal. Objectives To determine whether Hyoscine Butylbromide (Buscopan ®) and Drotaverine Hydrochloride (Nospa ®) would shorten the duration of the first stage of labour without any corresponding increase in maternal or neonatal complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Active management of Labour,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/01/2017
Actual trial start date 09/01/2017
Anticipated date of last follow up 31/03/2017
Actual Last follow-up date 30/04/2017
Anticipated target sample size (number of participants) 99
Actual target sample size (number of participants) 99
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
ADM/DCST/HREC/APP/1227 NHREC: 19/12/2008a
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 randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group HYOSCINE BUTYLBROMIDE 20mg Single dose 2ml of 20mg Hyoscine butylbromide (an antispasmodic agent) 33 Placebo
Experimental Group DROTAVERINE HYDROCHLORIDE 40mg Single dose 2ml of 40mg Drotaverine Hydrochloride 33
Control Group Normal saline 2ml Single dose 2ml of normal saline 33 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
singleton pregnancy vertex presentation term pregnancy had no co-existing medical illness had no contraindication to vagina delivery had spontaneous rupture of membrane in labour but not more than 12 hours duration. parturient who had previous uterine surgeries fetal malpresentation antepartum haemorrhage twin pregnancy chronic medical illness prolonged premature rupture of fetal membranes epidural analgesia in labour parturients with contraindication to vagina delivery 18 Year(s) 44 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 10/10/2016 LAGOS UNIVERSITY TEACHING HOSPITAL HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
ROOM 107, Ist FLOOR, LUTH Administarative Block Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Rate of cervical dilatation in the active phase of first stage of labour and Time to full cervical dilatation 2 hours after enrolment. 4 hours after enrolment. Full cervical dilatation.
Secondary Outcome Duration of second and third stage of labour. Potential fetomaternal complications. Labour pain score Duration of second stage - within 2 hours of achieving full cervical dilatation Duration of third stage - within 30 minutes of delivery of baby
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Idi-araba Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Morakinyo Abiodun ALAKALOKO Obstetrics and Gynaecology Department, Lagos University Teaching Hospital Lagos 12003 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Morakinyo Abiodun ALAKALOKO Obstetrics and Gynaecology Department, Lagos University Teaching Hospital Lagos 12003 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr Christian Chigozie MAKWE Obstetrics and Gynaecology Department, Lagos University Teaching Hospital Lagos 12003 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Morakinyo Abiodun Alakaloko morakinyoalakaloko@gmail.com +2348060075255 Obstetrics and Gynaecology department, Lagos University Teaching Hospital
City Postal code Country Position/Affiliation
Lagos 12003 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Morakinyo Abiodun Alakaloko morakinyoalakaloko@gmail.com +2348060075255 Obstetrics and Gynaecology department, Lagos University Teaching Hospital
City Postal code Country Position/Affiliation
Lagos 12003 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Christian Chigozie Makwe makwe285@yahoo.com +2348033358021 Obstetrics and Gynaecology department, Lagos University Teaching Hospital
City Postal code Country Position/Affiliation
Lagos 12003 Nigeria Senior Lecturer and Consultant
REPORTING
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