The purpose of this study was to determine the combined effect of Isosorbide with Misoprostol and Misoprostol alone on induction of labor in primigravida.
Design
This randomized double blind clinical trial was conducted on 150 primiparous women with singleton pregnancy and Bishop score less than 6 at the Ayatollah Rouhani Hospital in Babol. Women were randomly divided into two groups.
Settings and conduct
This study was conducted on all primigravida who were pregnant at 40+6 weeks of gestation who needed induction of labor and were admitted to the maternity hospital of Ayatollah Rouhani Hospital in Babol in October 2017.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primigravida women from 18 to 40 years old, Bishop Score 6 and less with a range score of 0 to 13, Body mass index in the first trimester of pregnancy in the normal range (19.8 - 26 kg/m2), 41 weeks pregnancy based on ultasonography of the first trimester of pregnancy, Singleton and cephalic pregnancy, Having a normal fetal heart rate or proper biophysical in 48 hours before entering the study .
Exclusion criteria: Pregnant women with a history of headache, Misoprostol contraindications, Alcohol consumption, Preeclampsia and eclampsia, Uncontrolled Diabetes, Intrauterine growth restriction, Polyhydramnios and oligohydramnios, Placenta previa or any other factor that prevents the induction of labor.
Intervention groups
In the intervention group, isosorbide tablet (Isocor Tablets, 40 mg, Aria Pharmacy) and in the control group, placebo placed vaginally in the posterior fornix, vagina by the senior gynecology resident. Then 24 hours later in both groups, after re-establishing a Bishop: 25 micrograms vaginal misoprostol (mcg, P.I.C, High Wycombe, England) are placed in the posterior fornix, vagina.
Main outcome variables
Induction of labor, Delivery method, Delivery length, Congenital and Neonatal
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180922041083N1
Registration date:2018-12-27, 1397/10/06
Registration timing:retrospective
Last update:2018-12-27, 1397/10/06
Update count:1
Registration date
2018-12-27, 1397/10/06
Registrant information
Name
Shahnaz Barat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3222 7667
Email address
sh.barat@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the combined effect of Isosorbide with Misoprostol and Misoprostol alone on induction of labor in primigravida
Public title
Effect of Isosorbide with Misoprostol and Misoprostol alone on induction of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mothers from 18 to 40 years old
Bishop Score 6 and less with a range score of 0 to 13
Body mass in the first trimester of pregnancy in the normal range (26 - 19.8 kg . m2)
41 weeks pregnancy based on ultrasonography of the first trimester of pregnancy
Singleton and cephalic pregnancy
Having a normal fetal heart rate or proper biophysical in 48 hours before entering the study
Exclusion criteria:
Pregnant women with a history of headache
Misoprostol contraindications
Alcohol consumption
Preeclampsia and eclampsia
Uncontrolled diabetes
Intrauterine growth restriction
Polyhydramnios and oligohydramnios
Placenta previa or any other factor that prevents the induction of labor
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Care provider
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Isosorbide and placebo tablets, which are very similar in appearance, are located in two containers A and B, and the senior resident of gynecology and people eligible for inclusion are not aware of the used drug, and the drug was given to patients based on a randomized number table. Only one person who was in charge of the maternity was aware of the drug doses of both containers.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afrouz Avenue
City
Babol
Province
Mazandaran
Postal code
4716681451
Approval date
2018-08-20, 1397/05/29
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.122
Health conditions studied
1
Description of health condition studied
Vaginal Delivery
ICD-10 code
O80.0
ICD-10 code description
Spontaneous Vertex Delivery
Primary outcomes
1
Description
Necessity of induction
Timepoint
During the intervention
Method of measurement
Observation and Examination
Secondary outcomes
1
Description
Method of delivery
Timepoint
During the intervention
Method of measurement
Observation and Examination
2
Description
Duration the first stage of labor
Timepoint
Active stage of labor
Method of measurement
Hour
3
Description
Maternal complications (Over stimulation of the uterus, headaches, tachycardia, hypotension, nausea, vomiting, and dizziness)
Timepoint
During the intervention
Method of measurement
Observation and Examination
4
Description
Neonatal outcomes (Apgar score at first and fifth minutes, birth weight, hospitalization of neonate in the Neonatal Intensive Care Unit)
Timepoint
During the intervention
Method of measurement
Observation and Examination
Intervention groups
1
Description
In the Intervention group, Isosorbide tablets (Isocor Tablet, 40 m, Aria Pharmacy) are used vaginally. Then 24 hours later, after re-establishing a bishop: 25 microgram vaginal misoprostol (P.I.C, High Wycombe, England) is placed in the posterior fornix of the vagina.
Category
Treatment - Drugs
2
Description
In the control group, the placebo is placed by the senior resident of gynecology in the posterior fornix of the vagina, and 24 hours later, after re-establishing a bishop, 25 microgram vaginal misoprostol (P.I.C, High Wycombe, England) are placed in the posterior fornix of the vagina.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital Babol
Full name of responsible person
Dr. Shanaz Barat
Street address
Ayatollah Rouhani Hospital in Babol, Ganj Afrooz Avenue,
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3222 7667
Email
shahnaz-barat200@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. reza Ghadimi
Street address
Babol University of Medical Sciences, Ganj Afrouz Avenue
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3222 7667
Email
rezaghadimi@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Barat
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University of Medical Sciences, Ganj Afrouz Avenue
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3222 7667
Email
shahnaz-barat200@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mobina Baes
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University of Medical Sciences, Ganj Afrouz Avenue
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3222 7667
Email
neda_amani60@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Barat
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University of Medical Sciences, Ganj Afrouz Avenue
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3222 7667
Email
shahnaz-barat200@yahoo.com
Web page address
http://www.mubabol.ac.ir/
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