Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000420943
Ethics application status
Approved
Date submitted
9/04/2011
Date registered
21/04/2011
Date last updated
26/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized Clinical Trial between Titrated oral dose of Misoprostol and Propess for Induction of Labor
Scientific title
Randomized Clinical Trial between Titrated oral dose of Misoprostol and Propess for Induction of Labor
Secondary ID [1] 259960 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Induction of labor 265588 0
Condition category
Condition code
Reproductive Health and Childbirth 265733 265733 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
20 mcg (20 ml) of the solution of misoprostol, as prescribed by the physician, is given to the patient orally every hour for 2 hours. If no uterine activity is present, increase the misoprostol dose by 10 mcg (10 ml) i.e. 30 mcg (30) and continue this dose every hour for 3 hours. Active labor is defined as regular uterine contractions occurring every 3-5 minutes and lasting 60 seconds or more. If the patient is not in active labor, 2 hours of observation without any dose was given. If still not in labor, increase the dose by 10 mcg (10 ml) i.e. 40 mcg (40 ml) for one hour. This is followed by 2 hours of observation. If still not in active labor the dose is increased by 10 mcg (10 ml) i.e. 50 mcg (50 ml) for one hour and finally increased by 10 mcg (10 ml) i.e. 60 mcg (60 ml) hourly for four hours, oxytocin should be started as per hospital's protocol. Oxytocin should be started no sooner than 2 hours after the last misoprostol dose. Once active labor is established, misoprostol is stopped.
Intervention code [1] 264370 0
Treatment: Drugs
Comparator / control treatment
Propess 10 mg vaginal insert in the vagina for 24 hours.
Control group
Active

Outcomes
Primary outcome [1] 266492 0
To achieve induction
Timepoint [1] 266492 0
After delivery and before discharge from the hospital (within five days of randomization).
Secondary outcome [1] 273891 0
Nausea, vomitting, and any other side-effects including hypersensitivity reaction. Chart review will be done immediately after delivery will be done.
Timepoint [1] 273891 0
After deilvery and before discharge from the hospital (within five days).

Eligibility
Key inclusion criteria
1. Singleton pregnancy for induction of labor.
2. Consent is taken.
3. No contraindication to use either drugs.
4. Bishop score <6.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. <34 wks gestation.
2. Severe PIH (abnormal LFT’s, protein>1g/day, BPgreater than or equal to 160/100).
3. Previous C/S or other uterine surgery.
4. Twins.
5. Para (number of previous deliveries) four.
6. Uterine contractions.

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)
Part 1: Identification of women for induction
During this part of the project, the following research activities will be achieved: Identification of women for induction as described in the research design section.

Part 2: Recruitment into the study
During this part of the project, the following research activities are to be achieved: Evaluation of the patients as described in the research design section.

Part 3: Randommization and execution of the study
Allocation of the patients as described in the research design section (by sealed opaque envelops).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2011
Actual
1/01/2011
Date of last participant enrolment
Anticipated
1/07/2012
Actual
1/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 3346 0
Saudi Arabia
State/province [1] 3346 0

Funding & Sponsors
Funding source category [1] 264844 0
University
Name [1] 264844 0
King Abdulaziz University
Country [1] 264844 0
Saudi Arabia
Primary sponsor type
University
Name
King Abdulaziz University
Address
PO Box 80215
Jeddah 21589
Country
Saudi Arabia
Secondary sponsor category [1] 263945 0
None
Name [1] 263945 0
Address [1] 263945 0
Country [1] 263945 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266809 0
King Abdulaziz Hospital Ethical Committee
Ethics committee address [1] 266809 0
PO Box 80215
Jeddah 21589
Ethics committee country [1] 266809 0
Saudi Arabia
Date submitted for ethics approval [1] 266809 0
25/07/2010
Approval date [1] 266809 0
03/11/2010
Ethics approval number [1] 266809 0
1/10/0381

Summary
Brief summary
The main objective of the proposed research project is to determine the best protocol to induce labor. A randomized clinical trial will be done to compare two protocols of titrated oral misoprostol and vaginal dinoprostone. This study will have major clinical impact on a very important and frequent clinical situation.
This study will have major clinical impact on a very important and frequent clinical situation.
Testing the efficacy of titrated oral Misoprostol to achieve induction of labor with lower side effects by giving Misoprostol in lower doses and increased frequency.
Trial website
Nill
Trial related presentations / publications
Rouzi AA, Alsibiani S, Mansouri N, et al. Randomized clinical trial between hourly titrated oral misoprostol and vaginal dinoprostone for induction of
labor. Am J Obstet Gynecol 2014;210:56.e1-6.
Public notes

Contacts
Principal investigator
Name 32461 0
Prof Abdulrahim Rouzi
Address 32461 0
King Abdulaziz University, PO Box 80215, Jeddah 21589, Saudi Arabia
Country 32461 0
Saudi Arabia
Phone 32461 0
966505602587
Fax 32461 0
96626408316
Email 32461 0
[email protected]
Contact person for public queries
Name 15708 0
Prof Abdulrahim A. Rouzi
Address 15708 0
PO Box 80215
Jeddah 21589
Country 15708 0
Saudi Arabia
Phone 15708 0
966505602587
Fax 15708 0
96626408316
Email 15708 0
[email protected]
Contact person for scientific queries
Name 6636 0
Prof Abdulrahim A. Rouzi
Address 6636 0
PO Box 80215
Jeddah 21589
Country 6636 0
Saudi Arabia
Phone 6636 0
966505602587
Fax 6636 0
96626408316
Email 6636 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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