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Trial registered on ANZCTR


Registration number
ACTRN12613000479707
Ethics application status
Approved
Date submitted
21/04/2013
Date registered
30/04/2013
Date last updated
2/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized Control Trial between Two Hourly Oral Misoprostol and Propess for Induction of Labor
Scientific title
Randomized Control Trial between Two Hourly Oral Misoprostol and Propess for Induction of Labor
Secondary ID [1] 282362 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Induction of labor. 288936 0
Condition category
Condition code
Reproductive Health and Childbirth 289274 289274 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A: 20 mcg misoprostol orally every 2 hours
A tablet (200 mcg) misoprostol will be dissolved in 200 mL water, producing a 1 mcg/mL solution. Achieving a uniform solution may be facilitated by crushing the tablet and/or using warm water to dissolve. Each 2 hourly oral dose will be provided as 20 mL of the misoprostol solution. Dosing will be continued until the subject achieves active labor (regular contractions occurring each 3 to 5 minutes, and lasting at least 60 seconds).
Intervention code [1] 286991 0
Treatment: Drugs
Comparator / control treatment
Group B: Propess 'Registered Trademark' – vaginal dinoprostone pessary
A 10 mg dinoprostone pessary will be inserted vaginally until the subject achieves active labor (regular contractions occurring each 3 to 5 minutes, and lasting at least 60 seconds). It will be removed after 24 hours if active labor does not occur.
Control group
Active

Outcomes
Primary outcome [1] 289397 0
The primary outcome is proportion of subjects achieving vaginal delivery within 24 hours.
Timepoint [1] 289397 0
Vaginal delivery within 24 hours.
Secondary outcome [1] 302395 0
Mean time to delivery
Timepoint [1] 302395 0
At delivery, the mean time from start of labor till delivery will be compared between the two groups.
Secondary outcome [2] 302415 0
Rate of cesarean section
Timepoint [2] 302415 0
The rate of cesarean section in the two groups from the start of induction will be compared.
Secondary outcome [3] 302416 0
Use of oxytocin augmentation.
Timepoint [3] 302416 0
The duration of oxytocin use from start till delivery will be determined.
Secondary outcome [4] 302417 0
Apgar score <7 at 5 minutes
Timepoint [4] 302417 0
Apgar score at 5 minutes will be determined.
Secondary outcome [5] 302460 0
Neonatal Intensive Care Unit (NICU) admission.
Timepoint [5] 302460 0
After delivery, the rate of NICU admission will be compared in the two groups.

Eligibility
Key inclusion criteria
1. Singleton pregnancy for induction of labor
2. No contraindication to either drug
3. Bishop score <6
4. Documented nonreactive stress test (NST)
5. Written informed consent
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. <34 weeks gestation
2. Severe pregnancy induced hypertension
3. Previous C/S or other uterine surgery
4. Parity 4 and more
5. Current 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)
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 using 3 block sizes. The resultant 37 blocks will be randomized to determine final treatment order. The study will not be blinded, increasing the importance of diligent attention to allocation concealment. For this purpose, sealed opaque envelopes containing sequential treatment order assignments will be provided to the recruitment center (define where that is). In the event multiple subjects are available at the same time, sequential opening of envelopes will assure “picking” the treatments is precluded. The screening and enrollment logs will be maintained at the recruitment center.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
19/11/2012
Actual
Date of last participant enrolment
Anticipated
30/12/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 5037 0
Saudi Arabia
State/province [1] 5037 0

Funding & Sponsors
Funding source category [1] 287141 0
Self funded/Unfunded
Name [1] 287141 0
None.
Country [1] 287141 0
Primary sponsor type
Hospital
Name
King Fahad Armed Forces Hospital
Address
PO Box 80215,
Jeddah, 21589
Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 285910 0
None
Name [1] 285910 0
None
Address [1] 285910 0
Country [1] 285910 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289141 0
King Fahad Armed Forces Hospital
Ethics committee address [1] 289141 0
PO Box 80215, Jeddah 21589
Ethics committee country [1] 289141 0
Saudi Arabia
Date submitted for ethics approval [1] 289141 0
01/10/2012
Approval date [1] 289141 0
01/11/2012
Ethics approval number [1] 289141 0

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 2 hourly treatment with 20 mcg oral misoprostol compared with 10 mg dinoprostone delivered via vaginal pessary.The primary objective is to compare the achievement of vaginal delivery within 24 hoursfollowing induction with static dose oral misoprostol and sustained-release vaginal dinoprostone.
Trial website
None.
Trial related presentations / publications
None.
Public notes
None.

Contacts
Principal investigator
Name 39418 0
Prof Abdulrahim Rouzi
Address 39418 0
King Abdulaziz University
PO Box 80215, Jeddah 21589
Country 39418 0
Saudi Arabia
Phone 39418 0
+966 505602587
Fax 39418 0
Email 39418 0
[email protected]
Contact person for public queries
Name 39419 0
Abdulrahim Rouzi
Address 39419 0
King Abdulaziz University
PO Box 80215
Jeddah 21589
Country 39419 0
Saudi Arabia
Phone 39419 0
+966 505602587
Fax 39419 0
Email 39419 0
[email protected]
Contact person for scientific queries
Name 39420 0
Abdulrahim Rouzi
Address 39420 0
King Abdulaziz University
PO Box 80215
Jeddah 21589
Country 39420 0
Saudi Arabia
Phone 39420 0
+966 505602587
Fax 39420 0
Email 39420 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
No additional documents have been identified.