ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

labor induction

obstetrics

misoprostol for labor induction

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Reproductive Health and Childbirth

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]

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]

Vaginal Birth rates

Timepoint [1]

At the conclusion of the study

Secondary outcome [1]

cesarean section rates

Timepoint [1]

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?

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]

Turkey

State/province [1]

Agri

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Elmin Eminov

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Elmin Eminov

Address

Country

Turkey

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Atatürk University Faculty of Medicine Clinical Research Ethics Committee

Ethics committee address [1]

Ataturk University Rectorate, Erzurum/Turkiye. PO Box: 25240

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

01/11/2022

Approval date [1]

01/12/2022

Ethics approval number [1]

B.30.2.ATA.0.01.00/751

Summary

Brief summary

The study consisted of 2 groups. 25 mcg vaginal misprostol was applied to the patients in the intervention group for labor induction. Patients in the control group were followed up spontaneously. The results of both groups were compared.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Elmin Eminov

Address

Duzce University, Faculty of Medicine, Duzce/Turkiye. PO Box:81100

Country

Turkey

Phone

+905301861803

Fax

[email protected]

Contact person for public queries

Name

Elmin Eminov

Address

Duzce University, Faculty of Medicine, Duzce/Turkiye. PO Box: 81100

Country

Turkey

Phone

+905301861803

Fax

[email protected]

Contact person for scientific queries

Name

Elmin Eminov

Address

Duzce University, Faculty of Medicine, Duzce/Turkiye. PO Box:81100

Country

Turkey

Phone

+905301861803

Fax

[email protected]

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.
[email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24112	Ethical approval					388326-(Uploaded-20-08-2024-17-23-26)-DocScan_07_23_2024.pdf

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			tables.docx

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically