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Trial registered on ANZCTR


Registration number
ACTRN12616000208404
Ethics application status
Approved
Date submitted
24/10/2015
Date registered
16/02/2016
Date last updated
1/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of intramuscular administration of dexamethasone alone or in combination of hyoscine butylbromide in shortening the duration of induced labour in Primigravida
Scientific title
The effect of intramuscular administration of dexamethasone alone or in combination of hyoscine butylbromide in shortening the duration of induced labour in Primigravida
Secondary ID [1] 287724 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prolonged labour 296563 0
Condition category
Condition code
Reproductive Health and Childbirth 296823 296823 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
compare effect of dexamethasone alone or in combination with hyoscine butylbromide on the duration of labour. In group A, 50 women will receive intramuscular 2 ml dexamethasone (8mg) 6 hours before induction of labour then intramuscular 2 ml saline with the beginning of active phase. In group B,50 women will receive intramuscular 2 ml dexamethasone (8mg) 6 hours before induction of labour then intramuscular 2 ml hyoscine butylbromide (40 mg) with the beginning of active phase. induction of labour will be done by using the following protocol; 2.5 mIU/min of oxytocin intravenous drip (in 500 mL lactated Ringer’s solution), with the dose increased by 2.5 mIU/ml every 20min till labour Establishment
Intervention code [1] 293114 0
Treatment: Drugs
Comparator / control treatment
In group C (control group), 50 women will receive two intramuscular saline injections (2 mL) 6 hours hours before induction of labour & with the beginning of active phase.
Control group
Placebo

Outcomes
Primary outcome [1] 296426 0
the duration of latent phase of 1st stage of labour
Timepoint [1] 296426 0
from the onset of regular uterine contraction (2-3) till beginning of active phase (defined as fully effaced cervix with 3-4 cm dilatation) . outcome will be assessed using partogram record of each patient
Primary outcome [2] 296663 0
the duration of active phase of 1st stage of labour
Timepoint [2] 296663 0
from fully effaced cervix with 3-4 cm dilatation till fully dilated cervix. outcome will be assessed using partogram record of each patient
Secondary outcome [1] 318415 0
mode of delivery
Timepoint [1] 318415 0
child birth. outcome will be assessed by reviewing hospital record of each patient
Secondary outcome [2] 319073 0
Apgar score at 1 & 5 minutes
Timepoint [2] 319073 0
immediately after child birth & 5 minutes later. outcome will be assessed by reviewing hospital records.

Eligibility
Key inclusion criteria
primigravidas with singleton living healthy fetus undergo induction of labour,gestational age 38 to 41+6 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan), vertex presentation of the fetus, favorable cervix (Bishop Score EQUAL TO 7) & intact membranes
Minimum age
18 Years
Maximum age
35 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who had chronic or pregnancy induced diseases or any contraindication to vaginal delivery (e.g. malpresentation, contracted pelvis & placenta previa), the maternal use of drugs (apart from nutritional supplementation), abnormal vaginal bleeding upon pelvic examination, abnormal fetal growth (IUGR or macrosomia), non-reassuring initial fetal CTG, presence of regular uterine contractions (3/10 mins.), uterine scar or anomalies, oligohydramnios (AFI < 5th percentile) & epidural analgesia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7267 0
Egypt
State/province [1] 7267 0
cairo

Funding & Sponsors
Funding source category [1] 292268 0
Self funded/Unfunded
Name [1] 292268 0
moutaz mahmoud elsherbini
Address [1] 292268 0
home address: 26 A el-mekyass st. el roda el-manyal (cairo Egypt)
work address: faculty of medicine - Cairo university ( 109 elmalek elsalah st. post code 11559
Country [1] 292268 0
Egypt
Primary sponsor type
Individual
Name
moutaz mahmoud elsherbini
Address
home address: 26 A el-mekyass st. el roda el-manyal (cairo Egypt)
work address: faculty of medicine - Cairo university ( 109 elmalek elsalah st. post code 11559
Country
Egypt
Secondary sponsor category [1] 290946 0
None
Name [1] 290946 0
Address [1] 290946 0
Country [1] 290946 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293743 0
faculty of medicine ethical committee (Cairo university)
Ethics committee address [1] 293743 0
elkasr elaini hospital- faculty of medicine - Cairo university ( 109 elmalek elsalah st. post code 11559)
Ethics committee country [1] 293743 0
Egypt
Date submitted for ethics approval [1] 293743 0
13/09/2015
Approval date [1] 293743 0
27/09/2015
Ethics approval number [1] 293743 0
1804268

Summary
Brief summary
Objective: To evaluate the impact of intramuscular (IM) dexamethasone alone or in combination of hyoscine butylbromide (HBB) on the duration of induced labour in Primigravida.
Study Design: A randomized Single-blind placebo controlled study.
Setting: The Obstetrics and Gynecology casuality department of Kasr El Aini hospital (Cairo University).
Methodology: 150 primigravidas with singleton living healthy fetus undergo induction of labour (IOL) will be enrolled in the study. They will be randomized into 3 groups: group A in which 50 women received IM dexamethasone (8mg) 6 hours before IOL then IM 2 ml saline with the beginning of active phase, group B in which 50 women received IM dexamethasone (8mg) 6 hours before IOL then IM HBB (40 mg) with the beginning of active phase & group C (control group) in which 50 women received two IM saline injections (2 mL) 6 hours before IOL & with the beginning of active phase.
For all patients, full history will be taken followed by complete physical examination & obstetric ultrasound. IOL will be done by using the following protocol; 2.5 mIU/min of oxytocin intravenous drip (in 500 mL lactated Ringer’s solution), with the dose increased by 2.5 mIU/ml every 20min till labour Establishment. Only patients will be blinded to the contents of syringes. Amniotomy will be done at cervical dilatation equal to 6 cm if spontaneous rupture of membranes does not occur. Participants will be monitored in bed together with fetal wellbeing surveillance using continuous CTG monitoring. A partogram will be maintained throughout labour and vaginal examinations will be conducted & recorded every 2 hours. primary outcomes will include comparing the duration of the latent phase of labour & the duration of active phase of labour among the three groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61130 0
Dr moutaz mahmoud elsherbini
Address 61130 0
home address: 26 A el-mekyass st. el roda el-manyal (cairo Egypt)
work address: faculty of medicine - Cairo university ( 109 elmalek elsalah st. post code 11559
Country 61130 0
Egypt
Phone 61130 0
+201001588300
Fax 61130 0
Email 61130 0
mizosherbini@yahoo.com
Contact person for public queries
Name 61131 0
Dr moutaz mahmoud elsherbini
Address 61131 0
home address: 26 A el-mekyass st. el roda el-manyal (cairo Egypt)
work address: faculty of medicine - Cairo university ( 109 elmalek elsalah st. post code 11559
Country 61131 0
Egypt
Phone 61131 0
+201001588300
Fax 61131 0
Email 61131 0
mizosherbini@yahoo.com
Contact person for scientific queries
Name 61132 0
Dr moutaz mahmoud elsherbini
Address 61132 0
home address: 26 A el-mekyass st. el roda el-manyal (cairo Egypt)
work address: faculty of medicine - Cairo university ( 109 elmalek elsalah st. post code 11559
Country 61132 0
Egypt
Phone 61132 0
+201001588300
Fax 61132 0
Email 61132 0
mizosherbini@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary