The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001269729
Ethics application status
Approved
Date submitted
13/11/2013
Date registered
18/11/2013
Date last updated
9/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized clinical trial between two protocols of oral misoprostol for induction of labor
Scientific title
Randomized clinical trial between two protocols of oral misoprostol for induction of labor
Secondary ID [1] 283581 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Labor induction. 290485 0
Condition category
Condition code
Reproductive Health and Childbirth 290886 290886 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hourly titrated oral misoprostol for induction of labor. Solution Preparation
Dissolve 200 mcg of misoprostol in 200 ml of water. The solution now has a misoprostol concentration of 1 mcg/ml.

Dosing
20 mcg (20 ml) of the solution to be given to the patient orally every hour until active labor was achieved or 4 doses given.

If uterine activity is present, but the patient is not in active labor, give the same dose and reassess in one hour.

If no uterine activity is present after 4 doses, increase the misoprostol dose to 40 mcg (40 ml) every hour until active labor was achieved or 4 doses given.

If uterine activity is present, but the patient is not in active labor, give the same dose and reassess in one hour.
If no uterine activity is present after 4 doses of 40 mcg or 40 ml (8 hours from the start), increase the misoprostol dose to 60 mcg (60 ml) every hour until active labor was achieved or 16 doses of 60 mcg given. Maximal total dose is 1200 mcg in 24 hours.

Once active labor is established at any dose, discontinue the misoprostol.
Intervention code [1] 288268 0
Treatment: Drugs
Comparator / control treatment
Two hourly oral misoprostol for induction of labor. Solution Preparation
Dissolve 200 mcg of misoprostol in 200 ml of water. The solution now has a misoprostol concentration of 1 mcg/ml.

Dosing
25 mcg (25 ml) of the solution to be given to the patient orally every 2 hours until active labor was achieved or 12 doses (300 mcg) given.

If uterine activity is present, but the patient is not in active labor, give the same dose and reassess in two hour.

Once active labor is established at any dose, discontinue the misoprostol.
Control group
Dose comparison

Outcomes
Primary outcome [1] 290870 0
The primary outcome is proportion of subjects achieving vaginal delivery within 24 hours from the first dose of misoprostol.
Timepoint [1] 290870 0
Proportion of subjects achieving vaginal delivery before 24 hours from the first dose of misoprostol immediately after the end delivery for all participants.
Secondary outcome [1] 305506 0
Mean time from start of misoprostol to delivery. Assessed at end of delivery for all participants
Timepoint [1] 305506 0
Mean time from start of induction till delivery. Assessed at end of delivery for all participants
Secondary outcome [2] 305508 0
Rate of cesarean section (the rate of cesarean section in the two groups from the start of induction will be compared after reviewing all participants medical records once they have all given birth).
Timepoint [2] 305508 0
The rate of cesarean section (the rate of cesarean section in the two groups from the start of induction will be compared after reviewing all participants medical records once they have all given birth).
Secondary outcome [3] 305509 0
If contractions decrease in frequency or strength, oxytocin should be started (use of oxytocin augmentation).
Timepoint [3] 305509 0
The duration of oxytocin use from start till delivery will be determined and assessed immediately after delivery
Secondary outcome [4] 305510 0
Apgar score at 5 minutes.
Timepoint [4] 305510 0
Apgar score at 5 minutes.
Secondary outcome [5] 305511 0
Rate of admission to Neonatal Intensive Care Unit (NICU) by reviewing the hospital charts.
Timepoint [5] 305511 0
After delivery, the rate of NICU admission will be compared in the two groups.

Eligibility
Key inclusion criteria
1. Singleton live pregnancy for induction of labor.
2. At or more than 34 weeks of gestation
3. Bishop score less than or equal to 6.
4. Intact membranes.
5. Cephalic presentation.
6. Reassuring fetal heart pattern.
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Hypersensitivity to misoprostol
2. Previous C/S or other uterine surgery.
3. Severe PIH (abnormal LFT’s, protein>1g/day, BP= 160/100).
4. Para 4 and more.
5. Multiple gestation.
6. Uterine contractions.
7. Significant maternal cardiac, renal , or liver disease.

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)
Women who meet eligibility criteria will be approached for possible enrollment. Allocation to the treatment arms will be done by opening a sealed opaque envelop.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be achieved via a computer-generated list.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The sample size calculation using alpha of 5%, beta 80%, power 80%, success rate of 95% in the hourly protocol and 80% in the 2 hourly protocol as determined from the literature, revealed that 76 patients in each arm are needed. Chi-square analysis, and the independent t-test, with P<.05 indicating statistical significance.

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] 5581 0
Saudi Arabia
State/province [1] 5581 0
Western

Funding & Sponsors
Funding source category [1] 288257 0
Self funded/Unfunded
Name [1] 288257 0
Address [1] 288257 0
Country [1] 288257 0
Primary sponsor type
Individual
Name
Abdulrahim Rouzi.
Address
King Abdulaziz University, PO Box 80215, Jeddah, 21589
Country
Saudi Arabia
Secondary sponsor category [1] 286975 0
None
Name [1] 286975 0
Address [1] 286975 0
Country [1] 286975 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290158 0
King Abdulaziz University
Ethics committee address [1] 290158 0
PO Box 80215,Jeddah 21589
Ethics committee country [1] 290158 0
Saudi Arabia
Date submitted for ethics approval [1] 290158 0
Approval date [1] 290158 0
11/11/2011
Ethics approval number [1] 290158 0
944-12

Summary
Brief summary
The research hypothesis is that more women for whom induction of labor is indicated will undergo vaginal delivery within 24 hours with hourly treatment with oral misoprostol compared with 2 hourly treatment.The primary objective is to compare the achievement of vaginal delivery within 24 hours following induction with hourly or 2 hourly oral misoprostol.
Trial website
None.
Trial related presentations / publications
None.
Public notes
None.

Contacts
Principal investigator
Name 44266 0
Prof Abdulrahim Rouzi
Address 44266 0
King Abdulaziz University. PO Box 80215, Jeddah 21589, Saudi Arabia
Country 44266 0
Saudi Arabia
Phone 44266 0
966505602587
Fax 44266 0
Email 44266 0
aarouzi@gmail.com
Contact person for public queries
Name 44267 0
Prof Abdulrahim Rouzi
Address 44267 0
King Abdulaziz Uinversity. PO Box 80215, Jeddah 21589, Saudi Arabia
Country 44267 0
Saudi Arabia
Phone 44267 0
966505602587
Fax 44267 0
Email 44267 0
aarouzi@gmail.com
Contact person for scientific queries
Name 44268 0
Prof Abdulrahim Rouzi
Address 44268 0
King Abdulaziz University. PO Box 80215, Jeddah 21589, Saudi Arabia
Country 44268 0
Saudi Arabia
Phone 44268 0
966505602587
Fax 44268 0
Email 44268 0
aarouzi@gmail.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