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.: PACTR201908521430230 Date of Approval: 05/08/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Progress of labour with hyoscine-n-butyl bromide: a randomized double-blind placebo-controlled study
Official scientific title Progress of labour with hyoscine-n-butyl bromide: a randomized double-blind placebo-controlled study
Brief summary describing the background and objectives of the trial Enhancing the progress of labour and thus preventing prolonged labour remain a major focus of the obstetrician. With prolonged labour, especially when complicated by obstruction, there is increased risk of maternal exhaustion, postpartum haemorrhage, sepsis, fetal distress and asphyxia. Cervical dilatation is an important factor which determines the progress of labour. Inhibitory impulses in the form of spasm often impair the dilatation of cervix and prolong the duration of labour. Slow progress of labour among primigravidae is mostly due to uterine inertia as demonstrated by O’Driscoll and Associates whereas in multipara, it is often due to issues like the thickened cervix or cervical spasm. Antispasmodic drugs, including hyoscine-n-butyl bromide are frequently employed to overcome cervical spasm and thus enhance the progress of labour. The objectives of the study are to determine, in multipara, the effect of intravenous hyoscine-n-butyl bromide on the duration of active phase of labour and on the rate of cervical dilatation from the point of intervention, to determine the incidence of the side effects of intravenous hyoscine-n-butyl bromide in the first stage of labour and neonatal Apgar score.
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 01/08/2019
Actual trial start date
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 172
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 Testing Augmentation of labour with oxytocin infusion as well as a single intravenous dose of 1 ml of 0.9% normal saline given slowly under aseptic condition Augmentation with oxytocin infusion will be done with 5 IU of oxytocin in 500ml of normal saline. The flow rate will start at 10 drops per minute and will be increased by 10 drops every 30 minute until patient is having 3-5 contractions in 10 minutes each lasting averagely 40 to 60 seconds. The flow rate will however not exceed 60 drops/min. Women admitted in active phase of labour whose cervical dilation rate is less than 1 cm/hour after the first review (four hours after admission), having less than 3 contractions in 10 minutes and/or contractions lasting less than 40 s in duration, with no feature of obstruction and who meet the inclusion criteria, will be randomized into two equal groups (86 in each group), control and experimental. The control group will have augmentation of labour with oxytocin infusion as well as a single intravenous dose of 1 ml of 0.9% normal saline given slowly under aseptic condition. Labour and its progress in each participant will continue to be monitored with the WHO partograph. 86 Active-Treatment of Control Group
Experimental Group Testing Augmentation of labour with oxytocin infusion and a single intravenous dose of 1 ml (20 mg) of hyoscine-n-butyl bromide given slowly under aseptic condition. Augmentation with oxytocin infusion will be done with 5 IU of oxytocin in 500ml of normal saline. The flow rate will start at 10 drops per minute and will be increased by 10 drops every 30 minute until patient is having 3-5 contractions in 10 minutes each lasting averagely 40 to 60 seconds. The flow rate will however not exceed 60 drops/min. Women admitted in active phase of labour whose cervical dilation rate is less than 1 cm/hour after the first review (four hours after admission), having less than 3 contractions in 10 minutes and/or contractions lasting less than 40 s in duration, with no feature of obstruction and who meet the inclusion criteria, will be randomized into two equal groups (86 in each group), control and experimental. The experimental group will have augmentation of labour with oxytocin infusion and a single intravenous dose of 1 ml (20 mg) of hyoscine-n-butyl bromide given slowly under aseptic condition. Labour and its progress in each participant will continue to be monitored with the WHO partograph. 86
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Multiparous pregnant women aged 18-40 years, with singleton pregnancy in cephalic presentation, admitted in active phase (at cervical dilatation of 4 to 6 cm) of spontaneous labour at term (37 weeks – 41 weeks + 6 days gestation) whose rate of cervical dilatation is less than 1 cm per hour as assessed four hours into admission Grand multiparity Multiple pregnancy Previous uterine scar Cervical dilation ≥ 7 cm at admission Cervical cerclage Chronic or pregnancy induced medical conditions Presence of any contraindication to vaginal delivery Allergy to hyoscine-n-butyl bromide History suggestive of, or previous diagnoses of glaucoma, myasthenia gravis, obstructive uropathy, asthma, cardiac, liver or renal disease, seizure disorder or psychiatric illness Prolonged Prelabour rupture of the fetal membranes (rupture of fetal membrane with latency period greater than 24hrs) Congenital fetal malformations Intra uterine growth restriction (IUGR) Cephalopelvic disproportion Intrauterine fetal death (IUFD) Non consenting patient Adult: 19 Year-44 Year 18 Year(s) 40 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 25/03/2019 Ekiti State University Teaching Hosptal Ado Ekiti Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
EKSUTH, Adebayo Street, Ado Ekiti Ado 360213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1.To determine the effect of intravenous hyoscine-n-butyl bromide on the duration of active phase of labour (from the point of intervention) From time of intervention/administration of the drug to full cervical dilatation
Secondary Outcome 1.To determine the effect of intravenous hyoscine-n-butyl bromide on the rate of cervical dilatation (from the point of intervention) From the time of intervention/administration of the drug to full cervical dilatation
Secondary Outcome 2.To determine the incidence of the side effects of intravenous hyoscine-n-butyl bromide in the first stage of labour From the time of intervention/administration of the drug to full cervical dilatation
Secondary Outcome 3.To determine the neonatal Apgar score at 1 and 5 minutes At the delivery of the neonate
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and Gynaecology Ekiti State University Teaching Hospital Adebayo Teaching Hospital Road Ado Ekiti Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Fagbohun Oluwamuyiwa EKSUTH, Adebayo street Ado Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fagbohun EKSUTH, Adebayo Street Ado Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Jacob Awoleke EKSUTH, Adebayo Street Ado Ekiti Nigeria
Dr Babatunde Olofinbiyi EKSUTH, Adebayo street Ado Ekiti Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oluwamuyiwa Fagbohun muyiwafagbohun@hotmail.com +2347062223910 Ekiti State University Teaching Hospital
City Postal code Country Position/Affiliation
Ado Ekiti Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Jacob Awoleke muyiwaawoleke@gmail.com +2348063289272 Ekiti State University Teaching Hospital
City Postal code Country Position/Affiliation
Ado Ekiti Nigeria Consultant Obstetrician and Gynaecologist
Role Name Email Phone Street address
Public Enquiries Babatunde Olofinbiyi tundeolofinbiyi@gmail.com +2348035033677 Ekiti State University Teaching Hospital
City Postal code Country Position/Affiliation
Ado Ekiti Nigeria Consultant Obstetrician and Gynaecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All IPD that underlie results of the trial Informed Consent Form,Statistical Analysis Plan,Study Protocol One year after publication IPD will be shared for meta-analysis. Request for IPD will be reviewed and approved by data custodian
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