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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607885056142 Date of Registration: 24/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of hyoscine butylbromide versus drotaverine hydrochloride on duration of active phase of labour among term parturients at Nauth, Nnewi: double-blind randomised controlled trial
Official scientific title Efficacy of hyoscine butylbromide versus drotaverine hydrochloride on duration of active phase of labour among term parturients at Nauth, Nnewi: double-blind randomised controlled trial
Brief summary describing the background and objectives of the trial World Health Organisation advocates for a positive childbirth experiences, which is hinged on a seamless labour process. However, when this labour process is prolonged, it can lead to detrimental effects for both mother and child. Efforts have been made to shorten this process with the use of various agents and hyoscine bromide and drotaverine have shown promising but varied outcomes in this regard. Hence, there is need to provide obstetricians with an ideal agent to be used in labor. Thereby mitigating the deleterious effects of prolonged labour ensuring that our women have a pleasant experience. Study aim To determine and compare the efficacy of hyoscine butylbromide versus drotaverine hydrochloride in shortening the active phase of labor in term pregnancies. Method This will be a randomized-controlled study that will be conducted in the Obstetrics and Gynaecology department of Nnamdi Azikiwe University Teaching Hospital (NAUTH), Nnewi, South-east Nigeria. One hundred and seventy-two consenting women will be randomized equally into three groups (1:1:1) receiving either 2ml of 20mg hyoscine butylbromide or 2ml of 40mg drotaverine hydrochloride or placebo The primary outcome measure will be the mean duration of the active phase of labour and secondary outcome measures will be the need for augmentation of labour and the need for neonatal resuscitation. Those included in the study will be pregnant women that met the criteria such as pregnant women at term, defined as gestational age from 37+0 to 41+6 weeks, Singleton pregnancy, fetus in cephalic presentation, active phase of labour with cervical dilatation of 5 cm at recruitment, age 18 years and above, willingness to participate and provision of written informed consent. The exculsion criteria will be women who are allergic to the drugs used or have a previous cesarean section. Data collected will be tabulated and then statistically analysed by intention-to-treat using the Statistical Product and Service Solutions
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 03/08/2026
Actual trial start date
Anticipated date of last follow up 13/01/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants)
Recruitment status Not yet 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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo 2mls of sterile water for injection Single intravenous injection The experimental group are consenting pregnant women who are in labour and have been ascertained to be at 5cm dilatation. After ascertaining eligiblity, written informed consent would be obtained. 2mls of sterile water for injection will be given once patient is noted to be 5cm dilated 70 Placebo
Experimental Group Hyoscine butylbromide 2mls of 20mg of hyoscine butylbromide Single intravenous injection given slowly over 5 mins The experimental group are consenting pregnant women who are in labour and have been ascertained to be at 5cm dilatation. After ascertaining eligiblity, written informed consent would be obtained. Intravenous hyoscine butylbromide 2mls of 20mg will be given once patient is noted to be 5cm dilated. 70
Experimental Group Drotaverine hydrochloride 2mls of 40mg drotaverine hydrochloride Single intravenous injection given over 5 minutes The experimental group are consenting pregnant women who are in labour and have been ascertained to be at 5cm dilatation. After ascertaining eligiblity, written informed consent would be obtained. Intravenous drotaverine hydrochloride 2mls of 40mg will be given once patient is noted to be 5cm dilated 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Pregnant women at term, defined as gestational age from 37+0 to 41+6 weeks. • Singleton pregnancy. • Fetus in cephalic presentation. • Active phase of labour with cervical dilatation of 4-5 cm at recruitment. • Age 18 years and above. • Willingness to participate and provision of written informed consent. • Previous cervical surgery or significant cervical trauma. • Contraindication to vaginal delivery. • Multiple pregnancy. • Non-cephalic presentation. • Medical illness that may affect labour or safety, such as severe preeclampsia, cardiac disease. • Known allergy to hyoscine butylbromide or drotaverine hydrochloride. Adult: 18 Year(s)-44 Year(s) 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
No 08/07/2026 Nnamdi Azikiwe unviersity teaching hospital health research ethics committee
Ethics Committee Address
Street address City Postal code Country
Akamili Nnewi 435101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Mean duration of the active phase of labour. Onset of active phase of labour to delivery
Secondary Outcome • the need for augmentation of labour • the need for neonatal resuscitation During active phase of labour and delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University teaching hospital Akamili Nnewi Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Kenechukwu Obi Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi 435101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenechukwu Obi Akamili Nnewi 435101 Nigeria Self
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kenechukwu Obi Obikenechukwu10@yahoo.com +2348106847957 Akamili
City Postal code Country Position/Affiliation
Nnewi Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Chiemezie Agbanu agbanufrank@gmail.com +2348138611735 Akamili
City Postal code Country Position/Affiliation
Nnewi Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Ikechukwu Mbachu imbachu@yahoo.com +2348035031726 Nnamdi Azikiwe University Teaching Hospital
City Postal code Country Position/Affiliation
Nnewi Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes Individual participant data shared after completion of study Informed Consent Form,Statistical Analysis Plan,Study Protocol 36 months post publication 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 24/07/2026 PACTR Admin EFFICACY OF HYOSCINE BUTYLBROMIDE VERSUS DROTAVERINE HYDROCHLORIDE ON DURATION OF ACTIVE PHASE OF LABOUR AMONG TERM PARTURIENTS AT NAUTH, NNEWI: DOUBLE-BLIND RANDOMISED CONTROLLED TRIAL Efficacy of hyoscine butylbromide versus drotaverine hydrochloride on duration of active phase of labour among term parturients at Nauth, Nnewi: double-blind randomised controlled trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 24/07/2026 PACTR Admin EFFICACY OF HYOSCINE BUTYLBROMIDE VERSUS DROTAVERINE HYDROCHLORIDE ON DURATION OF ACTIVE PHASE OF LABOUR AMONG TERM PARTURIENTS AT NAUTH, NNEWI: DOUBLE-BLIND RANDOMISED CONTROLLED TRIAL Efficacy of hyoscine butylbromide versus drotaverine hydrochloride on duration of active phase of labour among term parturients at Nauth, Nnewi: double-blind randomised controlled trial