A comparative study of the effectiveness and side effects of buccal and vaginal misoprostol in labor induction
Design
This is a randomized, unblinded clinical trial with a parallel design. This randomized study will be conducted on 42 candidate mothers to receive misoprostol. A random block is used for randomization and the participants are assigned to three intervention groups.
Settings and conduct
This study, which will be conducted in Imam Reza Hospital in Kermanshah city, is blinded. All mothers in this group are subjected to continuous fetal heart rate monitoring one hour before induction and one hour after, and after the onset of uterine contractions until delivery, they will be constantly monitored.
Participants/Inclusion and exclusion criteria
Inclusion criteria: monogamous; Pregnancy above 37 weeks; bishop's score less than/equal to 4; Cephalic presentation; live fetus, The weight of the fetus is less than 4 kilograms and the amniotic fluid index is more than 5
Exclusion criteria: Mothers who have contraindications for taking misoprostol
Intervention groups
The first intervention group of vaginal misoprostol will receive 25 micrograms of misoprostol (manufactured by Aria Pharmaceutical Company) vaginally.
The second intervention group will receive 25 micrograms of buccal misoprostol (between teeth and cheek mucosa). The third intervention group will receive 50 micrograms of buccal misoprostol (between teeth and cheek mucosa). In cases where Bishop's score did not change after 6 hours or appropriate uterine contractions (three contractions of more than 40 seconds in 10 minutes) did not occur, the next dose of misoprostol will be repeated and this process will continue for 24 hours.
Main outcome variables
Duration of labor, nausea, fever, chills
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N209
Registration date:2023-08-27, 1402/06/05
Registration timing:prospective
Last update:2023-08-27, 1402/06/05
Update count:0
Registration date
2023-08-27, 1402/06/05
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2024-05-09, 1403/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effectiveness and side effects of buccal and vaginal misoprostol in labor induction
Public title
Study of the effectiveness and side effects of buccal and vaginal misoprostol in labor induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Monogamous
Pregnancy above 37 weeks
bishop's score less than/equal to 4
Cephalic presentation
live fetus
The weight of the fetus is less than 4 kilograms and the amniotic fluid index is more than 5
Exclusion criteria:
Mothers who have contraindications for taking misoprostol (active cardiopulmonary disease, history of previous cesarean section, or history of major uterine surgery such as myomectomy and uterine reconstruction surgery).
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code.
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2023-05-28, 1402/03/07
Ethics committee reference number
IR.KUMS.MED.REC.1402.135
Health conditions studied
1
Description of health condition studied
labour induction
ICD-10 code
O61
ICD-10 code description
Failed induction of labor
Primary outcomes
1
Description
Duration of labor
Timepoint
End of study
Method of measurement
Based on the time measured from induction of labor to final delivery
2
Description
nausea
Timepoint
During the study
Method of measurement
Ask the patient
3
Description
fever
Timepoint
During the study
Method of measurement
Using a thermometer
4
Description
chills
Timepoint
During the study
Method of measurement
Ask the patient
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group of vaginal misoprostol will receive 25 micrograms of misoprostol (manufactured by Aria Pharmaceutical Company) vaginally.
Category
Treatment - Drugs
2
Description
The second intervention group will receive 25 micrograms of buccal misoprostol (between teeth and cheek mucosa).
Category
Treatment - Drugs
3
Description
The third intervention group will receive 50 micrograms of buccal misoprostol (between teeth and cheek mucosa).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Mahdis Akrami
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mahdis_akrami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mahdis Akrami
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mahdis_akrami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Maryam Zangeneh
Position
Member of the academic staff of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
mzangeneh@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mahdis Akrami
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mahdis_akrami@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD