Comparison of the effect of simultaneous administration of oxytocin with Foley catheter with co-administration of misoprostol and Foley catheter on cervical preparation and duration of labor in extended pregnancies.
Comparison of the effect of simultaneous administration of oxytocin with Foley catheter with co-administration of misoprostol and Foley catheter on cervical preparation and duration of labor
Design
This study is clinical trial which will be conducted on 74 pregnant women. In both groups, during labor, fetal heat beat and uterine contractions are monitored. General information on patients such as age, BMI, gestational age, indication of termination of pregnancy are entered in the self made questionnaire and afterwards, the primary outcome including cervix Bishop Score after 24 hours is then recorded every 4 hours until reaching Bishop Score of 7 (cervix is ready) and compared in both groups.
Settings and conduct
No blinding is done and patients admitted in Ommol-Banin, Ghaem and Imam Reza Hospitals in Mashhad enter the study in 2 groups using simple randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria : alive singleton pregnancy; gestational age of equal to or greater than 40 weeks; cephalic presentation; absence of fetal anomaly; Bishop Score of less than 4; mother's age is greater than 18; absence of medical illnesses such as diabetes and high blood pressure.
Exclusion criteria : placental abruption; chorioamnionitis; rupture of the membrane before the catheter is excreted; previous Cesarean section; Placenta Previa.
Intervention groups
Intervention group: simultaneous with placing Foley catheter, administration of oxytocin with dosage of 2 milliunits/min and addition of 2 milliunits every 20 minutes up to reaching a maximum of 30 milliunits/min. Control group: simultaneous with placing Foley catheter, sublingual misoprostol with dosage of 25 micro grams per every 4 hour up to a maximum of 6 dosages is prescribed.
Main outcome variables
Duration of reaching Bishop Score of 7 (cervix is ready) during 24 hours, is recorded every 4 hours.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181123041731N2
Registration date:2019-06-26, 1398/04/05
Registration timing:registered_while_recruiting
Last update:2019-06-26, 1398/04/05
Update count:0
Registration date
2019-06-26, 1398/04/05
Registrant information
Name
Malihe Rakhshani Far
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2861
Email address
rakhshanifm951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of simultaneous administration of oxytocin with Foley catheter with co-administration of misoprostol and Foley catheter on cervical preparation and duration of labor in extended pregnancies.
Public title
Comparison of the effect of simultaneous administration of oxytocin with Foley catheter with co-administration of misoprostol and Foley catheter on cervical preparation and duration of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Alive singleton pregnancy
Gestational age of equal to or greater than 40 weeks
Cephalic presentation
Absence of fetal anomaly
Weight estimate of the fetus is less than 4500 grams
Bishop Score of less than 4
Mother's age is greater than 18
Absence of parity of over 5
Absence of medical illnesses such as diabetes and high blood pressure
Exclusion criteria:
Placental abruption
Chorioamnionitis
Rupture of the membrane before the catheter is excreted
Previous Cesarean section
Gestational diabetes
Placenta Previa and any type of contraindication for vaginal bleeding
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is carried out using table of random numbers with the help of "www.randomization.com" website in which numbers are placed in sealed envelopes and once patients enter the study, envelopes are allocated to them placing them in one of the 2 groups.
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 Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-04-09, 1398/01/20
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.119
Health conditions studied
1
Description of health condition studied
extended pregnancies
ICD-10 code
O66.9
ICD-10 code description
Obstructed labor, unspecified
Primary outcomes
1
Description
Duration of reaching Bishop Score of 7 (the cervix is ready)
Timepoint
4 every 4 hours
Method of measurement
Internal examination
Secondary outcomes
1
Description
Duration of delivery
Timepoint
From admission to delivery
Method of measurement
Based on patient's file
2
Description
Delivery method
Timepoint
At the time of delivery
Method of measurement
Based on the type of delivery which is recorded in the patient's file
3
Description
Labor complications including tachysystole (more than 5 contractions in 10 minutes), bleeding after delivery
Timepoint
After delivery
Method of measurement
Clinical observation
Intervention groups
1
Description
Intervention group: immediately after placing the Foley catheter, administration of oxytocin with dosage of 2 milliunits/min begins and 2 milliunits are added every 20 minutes up to reaching a maximum of 30 milliunits/min. After excretion of catheter in the active phase (dilation of 6 centimeters) and in case of the head being fixed, amniotomy is carried out.
Category
Treatment - Drugs
2
Description
Control group: After embedding the Foley catheter, sublingual misoprostol with dosage of 25 micro gram per every 4 hour up to a maximum of 6 dosages is prescribed. In this group, also, after excretion of catheter in the active phase (dilation of 6 centimeters) and in case of the head being fixed, amniotomy is carried out.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Malihe Rakhshani Far
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2477
Email
Rakhshanifm951@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ommol-Banin hospital
Full name of responsible person
Masoumeh Mirteimouri
Street address
Ommol-Banin hospital, Azadi 16th, Azadi Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9144663595
Phone
+98 51 3223 1444
Email
mirteimourim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Rakhshani Far
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2477
Email
rakhshanifm951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Mirteimouri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ommol-Banin hospital, Azadi 16th, Azadi Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9144663595
Phone
+98 51 3223 1444
Email
mirteimourim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Rakhshani Far
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2477
Email
Rakhshanifm951@mums.ac.ir
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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.