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.: PACTR202206902932545 Date of Approval: 06/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title DROTAVERINE HYDROCHLORIDE VERSUS HYOSCINE BUTYLBROMIDE IN REDUCING FIRST STAGE OF LABOUR AMONG NULLIPARAE : A RANDOMIZED CONTROLLED TRIAL
Official scientific title DROTAVERINE HYDROCHLORIDE VERSUS HYOSCINE BUTYLBROMIDE IN REDUCING FIRST STAGE OF LABOUR AMONG NULLIPARAE : A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Background: Prolonged labour is a complication that could follow the active phase of labour in all women but may be seen commonly among nulliparae and if not averted could increase the risk of fetal morbidity and mortality. Various agents have been investigated in a bid to prevent prolonged labour, such agents include drotaverine hydrochloride and hyoscine butylbromide and have been found to have the potential to achieve a reduction in the duration of labour and prevent prolonged labour and its sequelae but to different degrees. Hyoscine butylbromide, has been in use in our facility to reduce the duration of labour but because of its anticholinergic side effects, drotverine hydrochloride without such side effects was studied to know if its efficacy in the reduction of the first stage of labour was better. The study is aimed at determining the efficacy of drotaverine hydrochloride versus hyoscine butyl bromide in reducing the duration of the first stage of labour among nulliparous women at the Alex-Ekwueme Federal University Teaching Hospital, Abakaliki.
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 24/05/2019
Actual trial start date 03/06/2019
Anticipated date of last follow up 01/07/2020
Actual Last follow-up date 01/06/2020
Anticipated target sample size (number of participants) 165
Actual target sample size (number of participants) 165
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
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group drotaverine group 2 ml (40 mg) of drotaverine hydrochloride Once, in active phase of labour Participants received a single dose of the drugs given through the radial artery above the wrist intravenously over 30 seconds, when they were assessed to be in active phase of labour. 55
Experimental Group hyoscine butyl bromide group 2 ml (20 mg) of hyoscine butyl bromide Once in active labour 2 ml (20 mg) of hyoscine butyl bromide. Participants received a single dose of the drugs given through the radial artery above the wrist intravenously over 30 seconds, when they were assessed to be in active phase of labour. 55
Control Group vitamin B complex group 2 ml of vitamin B complex in active phase of labour. Once in active phase of labour. Participants received a single dose of the drugs given through the radial artery above the wrist intravenously over 30 seconds, when they were assessed to be in active phase of labour. 55 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Nulliparae 2. Women who consented to participate in the study 3. Women with fetus in cephalic presentation 4. Singleton fetus with no evidence of maternal or fetal distress. 5. Women with no contraindication to vaginal delivery. 6. Term pregnancies with intact or ruptured membranes 7. Cervical dilatation of 4-5 cm only 8. Spontaneous or induced labour 9. Patients on epidural 1 Women with abnormal fetal presentation. 2. Women in latent phase of labour. 3. Preterm / term premature rupture of membranes. 4. Antepartum haemorrhage. 5. Those who refused to consent. 6. Previous uterine scar or surgery. 7. Huge fibroid in pregnancy. 8. Multiple gestations. 9. Multiparous or grand multiparous patients. 10. Medical diseases in pregnancy such as severe preeclampsia/eclampsia and others. 11. History of cervical surgery. 12. Hypersensitivity to drotaverine hydrochloride. 13. Any contraindication to vaginal delivery Adult: 19 Year-44 Year 19 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 07/05/2019 Rsearch and Ethics committee of Alex Ekwueme Federal University Teaching Hospital Abakaliki
Ethics Committee Address
Street address City Postal code Country
6 Ejiofor street Abakaliki Abakaliki 480 Nigeria
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 07/05/2019 Research and Ethics Committee of Mile 4 Hospital Abakaliki
Ethics Committee Address
Street address City Postal code Country
Mile 4 road Abakaliki Abakaliki 460 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • To determine the efficacy of drotaverine hydrochloride versus hyoscine butyl bromide in reducing the duration of first stage of labour among nulliparous women At full cervical dilatation of 10 cm
Secondary Outcome • To determine the rate of cervical dilatation in the first stage of labour, after administration of drotaverine hydrochloride (in one group) and hyoscine butylbromide (in another group). • To determine the side effects of these drugs on the mother and the baby. • To compare the rate of cervical dilatation and side effects to the mother and baby following the use of drotaverine hydrochloride and hyoscine butylbromide. • To compare participants’ satisfaction with the use of drotaverine hydrochloride and hyoscine butyl bromide during labour. During active labour and within 48 hours after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Ekwueme Federal University Teaching Hospital Abakaliki No 6 Ejiofor street Abakaliki Abakaliki 480 Nigeria
Mile 4 Hospital Abakaliki Ebonyi state Mile 4 Road Abakaliki Abakaliki 480 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
nweke nnenna No 6 Ejiofor street Abakaliki Abakaliki 480 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Chidebe C Anikwe 6 Ejiofor street Abakaliki Abakaliki 480 Nigeria Individual
Primary Sponsor Nnenna S Nweke 6 Ejiofor Street Abakaliki Abakaliki 480 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nnenna Nweke ninasophia4iyke@gmail.com +2348035489950 6 Ejiofor Street
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria consultant
Role Name Email Phone Street address
Scientific Enquiries Chidebe Anikwe drchideanikwechristian@gmail.com +2348064165965 6 ejiofor street Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries Nnenna Nweke ninasophia4iyke@gmail.com +2348035489950 6 Ejiofor street
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the result reported in the article after deidentification ( text , tables,figures) Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 9 months to end at 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee
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