Protocol summary

Study aim
Comparison of the effect of misoprostol on vaginal, sublingual and buccal methods in induction of labor in term pregnancies. Comparison of cesarean section among three groups Comparison of the need for oxytocin in three groups Comparison of maternal complications among the three groups Comparison of fetal complications among the three groups
Design
Three parallel group, Randomised trial , without blinded
Settings and conduct
The study population of this study is women referred to Qazvin Kosar Hospital during the year 2018 who are randomly divided into 3 groups of Misoprostol buccal, sublingual and vaginal. The final sample size is about 100patients per group (300 patients). The data collection is based on the previous checklist. The data are analyzed using SPSS21 software and Kruskal-Wallis analysis, variance tests, mean, and standard deviation were used.
Participants/Inclusion and exclusion criteria
The present study will be conducted as a clinical trial. All patients referring to Kowsar Hospital, who had indications of delivery for maternal reasons, included criteria for entering the study, and if they don not have the criteria for exit, they would enter the study after completing the informed consent form. The age of the mother, the gestational age, the BMI of the mother, and the Bishop score in the first visit are recorded by the resident of the gynecologist. The gestational age is determined based on the last menstruation date confirmed by early ultrasonography. Patients are randomly divided into three groups based on randomized method.
Intervention groups
the first group, recieved vaginal misoprostol 25 mcg every 6 hours until24 hours, the second group received 50 mcg sublingual misoprostol every 6 hours until24 hours, and the third group received 50 mcg misoprostol buccal every 6 hours until24 hours for induction of labor
Main outcome variables
Choosing the best, least expensive, most effective, and least complicated therapies for induction of childbirth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180121038465N1
Registration date: 2018-03-17, 1396/12/26
Registration timing: registered_while_recruiting

Last update: 2018-03-17, 1396/12/26
Update count: 0
Registration date
2018-03-17, 1396/12/26
Registrant information
Name
Razieh Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3350 4866
Email address
raziehakbari9@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-14, 1396/12/23
Expected recruitment end date
2018-07-01, 1397/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Vaginal Misoprostol with buccal and sublingual Misoprostol in Labor Induction in Term Pregnancy
Public title
The Comparison of Vaginal Misoprostol with buccal and sublingual Misoprostol in Labor Induction in Term Pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
single, bishop score≤4, cephalic presentation, NST reactive, parity ≤2, gestational age more than 37 w, Amniotic fluid index ≥5
Exclusion criteria:
maternal medical diseases breech presentation fetal anomaly
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization was performed in this research.
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 Qazvin University of Medical Sciences
Street address
Kousar Hospital, Ayatolah Khamenei Ave, Qazvin
City
Qazvin
Province
Qazvin
Postal code
13176- 34156
Approval date
2018-03-13, 1396/12/22
Ethics committee reference number
IR.qums.rec.1396.497

Health conditions studied

1

Description of health condition studied
induction of labour
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The effect of misoprostol in induction of labor
Timepoint
every 6h to 24h
Method of measurement
bishop score and time of delivery

Secondary outcomes

1

Description
the rate of Cesarean section
Timepoint
delivery
Method of measurement
cesarean/ NVD

2

Description
reason of cesarean
Timepoint
during delivery
Method of measurement
mecunium, FHR deceleration, No responce to induction

3

Description
time to the active phase of labor
Timepoint
0-6-24 hr
Method of measurement
Bishop Score

4

Description
need for oxytocin
Timepoint
until delivery
Method of measurement
yes/no

5

Description
number of misoprostol doses
Timepoint
until delivery
Method of measurement
1-2-3

6

Description
fetal complications
Timepoint
until delivery
Method of measurement
abnormal pattern of fetal heart rate, meconium, Apgar score 1 and 5 postpartum, and admission to neonatal intensive care unit

7

Description
maternal complication
Timepoint
until delivery
Method of measurement
Fever, chills, nausea, vomiting, uterine tachysystole, uterine hyperstimulation

Intervention groups

1

Description
Intervention group: Recipient of 50 μg misoprostol by buccal method up to three doses in case of no onset of labor pain
Category
Treatment - Devices

2

Description
Intervention group: Recipient of 50 μg misoprostol by sublingual method up to three doses in case of no onset of labor pain
Category
Treatment - Devices

3

Description
Control group: Recipient of 25μg misoprostol by vaginal method up to three doses in case of no onset of labor pain
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Kousar Hospital
Full name of responsible person
Razieh Akbari
Street address
Kousar Hospital, Shahid Taleghani Street, Kowsar Alley
City
Qazvin
Province
Qazvin
Postal code
13176- 34156
Phone
+98 28 3323 6374
Email
raziehakbari9@gmail.com
Web page address
http://hoskosar.qums.ac.ir/Portal/Home/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Qazvin University of Medical Sciences, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3333 6001
Email
apeymani@qums.ac.ir
Web page address
http://vcr.qums.ac.ir/portal/home/default.aspx?categoryid=c8d7bfff-95fd-4021-bfa1-6b2415a02d7c&rnd=44115.18399915726
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Razieh Akbari
Position
Gynocology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Qazvin- Kosar Hospital
City
Qazvin
Province
Tehran
Postal code
1175765715
Phone
+98 21 3350 4866
Fax
Email
raziehakbari9@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Razieh Akbari
Position
Gynocology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Qazvin- Kosar Hospital
City
Qazvin
Province
Tehran
Postal code
1175765715
Phone
+98 21 3350 4866
Fax
Email
raziehakbari9@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Razieh Akbari
Position
Gynocology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Qazvin- Kosar Hospital
City
Qazvin
Province
Tehran
Postal code
1175765715
Phone
+98 21 3350 4866
Fax
Email
raziehakbari9@gmail.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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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