Comparison of the efficacy of oral Misoprostol and Oxytocin during induction in pregnant women with premature rupture of fetal membranes at 28 to 37 weeks gestation
Design
Initially, a preliminary cervical examination and a Bishop score and a history taking will be done. The lubricating gel will not be made during the preparation of the article. After definitive diagnosis of splenic rupture in speculum examination or positive fron test, patients are randomly using a random number table divided into two groups to induce labor.
Settings and conduct
Pregnant women will be NPOs at births and receive a CCR of 120 CC / h. The case group will be given 50 micrograms of misoprostol orally. In the control group, oral placebo and intravenous oxytocin in ringer serum will be started. In both groups, accurate and continuous monitoring of fetal heart rate and uterine contractions and progression of labor will be performed. , Pregnant will undergo cesarean section. Failure to respond to induction will result in cases where the Bishop score changes to less than five despite 6 hours of favorable contractions.
Participants/Inclusion and exclusion criteria
Pregnant mothers who have ruptured premature of membrane between 28 and 37 weeks of gestation
Intervention groups
In the intervention group 50mg misoprostol will be given orally every 4 hours up to a maximum of 6 doses.
In the control group, oral placebo and intravenous oxytocin in ringer serum will be started at a dose of 2 mlu / min and 2 mlu / min every 10 minutes up to a maximum of 40 mlu / min.
Main outcome variables
Induction of labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191104045333N1
Registration date:2020-04-19, 1399/01/31
Registration timing:registered_while_recruiting
Last update:2020-04-19, 1399/01/31
Update count:0
Registration date
2020-04-19, 1399/01/31
Registrant information
Name
Sepideh Besharati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0980
Email address
sepideh_besharati@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Oral Misoprostol Tablets and Oxytocin for the Induction of Labor in Preterm Premature Rupture of Membranes
Public title
Preterm Labor and Mizoprostol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of rupture of membrane on examination with speculum or positive frenne test
Gestational age between 28 and 37 weeks
One Pregnancy
Cephalic presentation
Bishop score ≤5
Exclusion criteria:
Fetal Heart Rate disorder
Cesarean section history
Placenta Previa
Active cardiovascular disease, asthma, glaucoma
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be randomly divided into two groups using a random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will not be notified of the Mizoprostol or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2019-08-27, 1398/06/05
Ethics committee reference number
IR.SBMU.MSP.REC.1398.526
Health conditions studied
1
Description of health condition studied
Preterm Premature Rupture of Membranes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Induction of labor until delivery
Timepoint
From induction to delivery
Method of measurement
Information will be recorded in terms of the time interval between the start of induction and delivery.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50 µg oral misoprostol every 4 hours up to a maximum of 6 doses
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh hospital
Full name of responsible person
Sepideh Besharati
Street address
Shoush Square - Fadaiyan Eslam St - Glass House Alley - Shahid Rajab Nia St
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tayebeh jahed
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak,
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
tayebeh.jahed@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Spideh Besharati
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 6 , Alley 7,Sanjabi Street, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
sepideh_besharati@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sepideh Besharati
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 6, Alley 7, Sanjabi Street, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
sepideh_besharati@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sepideh Besharati
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 6, Alley 7, Sanjabi Street, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
sepideh_besharati@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available