Comparison of the effect of Oral and Vaginal Misoprostol on the Duration of First Labor Induction
Design
This study is a randomized, parallel-group clinical trial in which pregnant women who were candidates for induction were assigned to two groups: oral and vaginal misoprostol. Randomization was performed in a block design and there was no possibility of blinding participants or providers.
Settings and conduct
In this study, term pregnant mothers who were candidates for labor induction and who were eligible for the study were admitted to Afzalipour Hospital in Kerman. The randomization sequence was generated by a statistician using computer-generated random numbers with variable blocks (4 and 6) and an allocation ratio of 1:1. To conceal allocation, opaque, sealed, and numbered envelopes were used sequentially, and when each patient arrived, the next envelope was opened in order and the intervention group was determined.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Term pregnancy (Less than or equal to 37 weeks of gestation), Bishop Score Less Than or Equal To 6, First Birth of a Pregnant Mother
Exclusion criteria: Pregnant Women with Contraindications to Vaginal Delivery, Abnormal Fetal Heart Rate Pattern, Vaginal Bleeding, and Women with Known Hypersensitivity to Misoprostol or Prostaglandin Analogs.
Intervention groups
Group A: Misoprostol 50 micrograms(Abu Raihan Pharmaceutical) Tablet Orally Every 6 Hours Until Reaching a Bishop Score of More Than 8 or a Maximum Dose of Misoprostol 200 micrograms or the Onset of Active Labor and Cervical Effacement;
Group B: Misoprostol 25 micrograms Tablet Vaginally Every 6 Hours Until Reaching a Bishop Score of More Than 8 or A Maximum Dose of Misoprostol 200 µg or the Onset of Active Labor and Cervical Effacement
Main outcome variables
Time from Intervention to Natural Birth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250513065720N1
Registration date:2025-10-20, 1404/07/28
Registration timing:registered_while_recruiting
Last update:2025-10-20, 1404/07/28
Update count:0
Registration date
2025-10-20, 1404/07/28
Registrant information
Name
Zohreh Salari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8306
Email address
zohreh_salari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-22, 1404/05/31
Expected recruitment end date
2026-01-19, 1404/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Oral Vs Vaginal Misoprostol on The Duration of Induction of First Labor
Public title
The Effect of Oral and Vaginal Misoprostol on the Duration of first Labor Induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Term Pregnancy (Less than or Equal to 37 weeks of Gestation) with a Singleton is Estimated based on the LMP Criterion (if Regularly and Reliably Confirmed by a Specialist Physician) or Ultrasound.
Bishop Score Less than or Equal to 6
Cephalic Presentation of the fetus
Having an Intact Membrane
Reactivity of the Non-Stress Test
Amniotic fluid volume less than 5
Estimated Fetal Weight less than 4000 Grams
First Birth of a Pregnant Mother
Exclusion criteria:
Pregnant women with contraindications to vaginal delivery
Chorioamnionitis
HIV positivity
Previous uterine surgery
Abnormal fetal heartbeat pattern
Vaginal Bleeding and Women with Known Hypersensitivity to Misoprostol or Prostaglandin Analogues
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The Present Study Will be a Randomized Clinical Trial Study. The Statistical Population of this Study will be Pregnant Mothers in Their First Trimester Who are Candidates for Labor Induction and Who Refer to Afzalipour, Kerman.
The Random Allocation Sequence will be Generated by an Independent Statistician Using Computer-Generated Random Numbers (Blockrand Package in R Software) with Variable Block Sizes of 4 and 6, in a 1:1 Ratio (Oral Misoprostol : Vaginal Misoprostol).
Allocation Concealment will be Ensured Using Prepared By The Statistician, Who Is Not Involved in Patient Enrolment or Treatment.
Participant Enrolment will be Carried out by the Attending Physician or
Midwife, who will open The next Envelope in Sequence at the Time of Enrolment to Determine Group Allocation.
Due to the Nature of the Interventions, Blinding of Participants and Care Providers is not Feasible; However, Outcome Assessors and Data Analysts Will Remain Blinded to Group Allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Afzalipour Hospital- Kerman University of Medical Sciences
Street address
Afzalipour Hospital, Emam Khomeini Blv.
City
Kerman
Province
Kerman
Postal code
7616913355
Approval date
2025-04-29, 1404/02/09
Ethics committee reference number
IR.KMU.AH.REC.1404.022
Health conditions studied
1
Description of health condition studied
Childbirth
ICD-10 code
O75.8
ICD-10 code description
Other specified complications of labor and delivery
Primary outcomes
1
Description
Time from Intervention to Natural Birth
Timepoint
From the time of the first dose of Misoprostol to the delivery of the Baby
Method of measurement
Clinical Record, Physical Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: Misoprostol 50 Microgram Tablets (Mizotec Tablets, Abu Rayhan Pharmaceutical Company) Orally Every 6 Hours Until Reaching a Bishop Score of more than 8 or a Maximum Misoprostol Dose of 200 Micrograms or the Onset of Active Labor and Cervical Dilatation.
Category
Treatment - Drugs
2
Description
Intervention Group 2: Misoprostol 25 Microgram Tablet (Mizotec Tablets, Abu Raihan Pharmaceutical Company) Vaginally Every 6 Hours Until Reaching a Bishop Score of More than 8 or a Maximum Misoprostol Dose of 200 Micrograms or the Onset of the Active Phase of Labor and Cervical Dilatation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Maryam Toghrali
Street address
Afzalipour Hospital, Emam Khomeini Blv.
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
dr.maryamtoghroli@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamid Sharifi
Street address
Ebn-e-Sina St.,Jahad Blvd., Kernan
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3226 3855
Email
m.sharifi7996@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Toghrali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Afzalipour Hospital, Emam Khomeini Blv.
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
www.dr.maryamtoghroli@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Toghrali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Afzalipour Hospital, Emam Khomeini Blv.
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
www.dr.maryamtoghroli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Toghrali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Afzalipour Hospital, Emam Khomeini Blv.
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
www.dr.maryamtoghroli@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is Potentially Shareable after De-Identifying Individuals.
When the data will become available and for how long
starting 6 Months after Publication
To whom data/document is available
People Working in Academic Institutions
Under which criteria data/document could be used
With Previous Agreement with the Corresponding Author
From where data/document is obtainable
Corresponding Author, Email Address
What processes are involved for a request to access data/document