Comparing the Effect of Oral Misoprostol and Intravenous Oxytocin on Labor Induction
Design
A randomized, double blind, parallel clinical trial including 130 patients with postdate pregnancy receiving two intervention for induction of labor. The patients, intervention appliers and outcome assessors will be blinded toward the study groups.
Settings and conduct
A university hospital affiliated with Fasa University of Medical Sciences. The drugs would be prepared in pharmacology department in dark syringes and uniform tablets and would be provided to the physician and caring nurse blindly. Those recording the outcome will also be blinded toward the study groups.
Participants/Inclusion and exclusion criteria
We included women over 18 years old, singleton pregnancy, cervical closure (Bishop score greater than six), first and second pregnancy. We excluded those with multiple pregnancy, emergency cesarean section and maternal sensitivity to oxytocin, misoprostol and prostagalandin analogues.
Intervention groups
Patients in case group will receive 10 units of intravenous oxytocin for labor induction. Patients in control group will receive 50 mg oral Misoprostol every 4 hours for 2 days maximally.
Main outcome variables
Successful delivery within 48 hours after intervention
Route of delivery (Cesarean delivery vs Natural Vaginal delivery)
Frequency of uterine contractions per hour
Drug adverse effects
Apgar at 1- and 5-min
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171111037374N1
Registration date:2018-07-03, 1397/04/12
Registration timing:retrospective
Last update:2018-07-03, 1397/04/12
Update count:0
Registration date
2018-07-03, 1397/04/12
Registrant information
Name
Hadi Zare Marzouni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 861 2103
Email address
zaremh931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-26, 1397/01/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Oral Misoprostol and Intravenous Oxytocin on Labor Induction in pregnant women
Public title
Comparing the Effect of Oral Misoprostol and Intravenous Oxytocin on Labor Induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age more than 42 weeks
first and second pregnancy
women over 18 years old
singleton pregnancy,
cervical closure (Bishop score greater than six)
Exclusion criteria:
Multiple pregnancies
need for immediate cesarean section
history of uterine scarring
placenta previa
vaginal bleeding more than normal postpartum bleeding
heart, liver and kidney diseases
history of sensitivity to Oxytocin, Misoprostol or prostaglandin analogues
severe congenital anomalies in the fetus.
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
The included patients were randomly assigned to 2 study groups using a computer-based random digit generator utilizing the admission numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are unaware of being present in the case and control group. Also outcome assessor and data analyser will be blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Ebne Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2017-09-05, 1396/06/14
Ethics committee reference number
IR.FUMS.REC.1396.222
Health conditions studied
1
Description of health condition studied
Abdominal pregnancy
ICD-10 code
O00.0
ICD-10 code description
Abdominal pregnancy
2
Description of health condition studied
(Induced) termination of pregnancy with other and unspecified complications
ICD-10 code
O04.8
ICD-10 code description
(Induced) termination of pregnancy with other and unspecified complications
Primary outcomes
1
Description
Delivery withing 48 hours after intervention
Timepoint
48 hours after intervention
Method of measurement
Recording the number of patients with successful delivery within 48 hours
2
Description
Route of delivery
Timepoint
At time if delivery
Method of measurement
Recording the route of delivery (Cesarean or vaginal delivery)
3
Description
Neonatal Apgar
Timepoint
1 and 5 minutes after birth
Method of measurement
Apgar
Secondary outcomes
1
Description
Adverse Effects
Timepoint
1, 2, 4, 8 and 10 days after intervention
Method of measurement
Adverse drug effects form
Intervention groups
1
Description
Intervention group: 50 micrograms of oral misoprostol for induction of labor. If no appropriate uterine contractions were observed, patients received 50 mg Misoprostol every four hours and finally twice a day. Intravenous placebo was also received in the case group.
Category
Treatment - Drugs
2
Description
Control group: 10 units of Oxytocin dissolved in 1000 cc of dextrose 5% for labor induction. This group also received oral placebo tablets at the same time.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational hospital of Fasa University of Medical Science, Fasa, Iran
Full name of responsible person
Roya Kokabi
Street address
Fasa University of Medical Science, Fasa, Iran
City
Fasa
Province
Fars
Postal code
74616 86688
Phone
+98 71 5335 0994
Email
roya.kokabi11111@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mojtaba Farjam
Street address
Ebne Sina square, Fasa, Iran
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
farjam@fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Roya Kokabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ebne Sina square, Fasa
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
roya.kokabi11111@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Roya Kokabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ebne Sina square, Fasa
City
fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
roya.kokabi11111@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Roya Kokabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ebne Sina square, Fasa
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
roya.kokabi11111@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After the end of the project and the collection of information, the results are published as an article.
When the data will become available and for how long
The results will available 6 months after the publication
To whom data/document is available
The findings will be available to the public, researchers and clinicians.
Under which criteria data/document could be used
All data on which non-personally identifiable data is sampled are available.
From where data/document is obtainable
Applicants can receive information from the article. In addition, they can answer their questions from Corresponding Author by e-mail.
What processes are involved for a request to access data/document
Applicants can receive information from the article. In addition, they can answer their questions from Corresponding Author by e-mail.