Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001152516
Ethics application status
Approved
Date submitted
20/08/2024
Date registered
23/09/2024
Date last updated
23/09/2024
Date data sharing statement initially provided
23/09/2024
Date results provided
23/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the role of misoprostol in labor induction
Scientific title
Evaluating the role of misoprostol in inducing vaginal births for singleton pregnancies
Secondary ID [1] 312795 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
labor induction 334856 0
obstetrics 334857 0
misoprostol for labor induction 334858 0
Condition category
Condition code
Reproductive Health and Childbirth 331410 331410 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 331411 331411 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Since misoprostol is only indicated for postterm pregnant women for labor induction in our country, 25 mcg misoprostol was administered vaginally to women with a singleton pregnancy in vertex presentation, without previous uterine surgery, with a pregnancy of 42 weeks or more, and with a Bishop score of five and/or below. In patients with no response, the repeat dose was repeated a maximum of four times. Misoprostol was not administered to patients who did not want to receive labor induction or who went into spontaneous labor. Misoprostol was administered by a gynecologist and obstetrician. After the patients were administered misoprostol, NST was monitored continuously for the first two hours and at two-hour intervals in the following period. After the application, all data such as the patients' delivery times, delivery methods, cesarean delivery indications, and induction dose numbers were recorded by the gynecologist.
Intervention code [1] 329320 0
Treatment: Drugs
Comparator / control treatment
No application was made to the patients in the control group. The patients in this group were followed up spontaneously for birth.
Control group
Active

Outcomes
Primary outcome [1] 339158 0
Vaginal Birth rates
Timepoint [1] 339158 0
At the conclusion of the study
Secondary outcome [1] 438822 0
cesarean section rates
Timepoint [1] 438822 0
At the conclusion of the study

Eligibility
Key inclusion criteria
singleton pregnancy
fetus in cephalic presentation
participants who consented to the study
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
multiple pregnancy
presence of uterine surgery
malpresentation
placenta previa
asthma
glaucoma
disagreement to participate in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/12/2022
Date of last participant enrolment
Anticipated
Actual
1/12/2023
Date of last data collection
Anticipated
Actual
1/12/2023
Sample size
Target
500
Accrual to date
Final
313
Recruitment outside Australia
Country [1] 26520 0
Turkey
State/province [1] 26520 0
Agri

Funding & Sponsors
Funding source category [1] 317226 0
Self funded/Unfunded
Name [1] 317226 0
Elmin Eminov
Country [1] 317226 0
Primary sponsor type
Individual
Name
Elmin Eminov
Address
Country
Turkey
Secondary sponsor category [1] 319504 0
None
Name [1] 319504 0
Address [1] 319504 0
Country [1] 319504 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315963 0
Atatürk University Faculty of Medicine Clinical Research Ethics Committee
Ethics committee address [1] 315963 0
Ethics committee country [1] 315963 0
Turkey
Date submitted for ethics approval [1] 315963 0
01/11/2022
Approval date [1] 315963 0
01/12/2022
Ethics approval number [1] 315963 0
B.30.2.ATA.0.01.00/751

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136362 0
Dr Elmin Eminov
Address 136362 0
Duzce University, Faculty of Medicine, Duzce/Turkiye. PO Box:81100
Country 136362 0
Turkey
Phone 136362 0
+905301861803
Fax 136362 0
Email 136362 0
elmineminov@duzce.edu.tr
Contact person for public queries
Name 136363 0
Elmin Eminov
Address 136363 0
Duzce University, Faculty of Medicine, Duzce/Turkiye. PO Box: 81100
Country 136363 0
Turkey
Phone 136363 0
+905301861803
Fax 136363 0
Email 136363 0
elmineminov@duzce.edu.tr
Contact person for scientific queries
Name 136364 0
Elmin Eminov
Address 136364 0
Duzce University, Faculty of Medicine, Duzce/Turkiye. PO Box:81100
Country 136364 0
Turkey
Phone 136364 0
+905301861803
Fax 136364 0
Email 136364 0
elmineminov@duzce.edu.tr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Birth-related data of patients obtained from hospital data records
When will data be available (start and end dates)?
Immediately following publication and with no end date
Available to whom?
data will be publicly available
Available for what types of analyses?
IPD meta-analysis
How or where can data be obtained?
Data can be obtained from the director of the study, Elmin Eminov.
elmineminov@duzce.edu.tr


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24112Ethical approval    388326-(Uploaded-20-08-2024-17-23-26)-DocScan_07_23_2024.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo tables.docx

Documents added automatically
No additional documents have been identified.