This clinical trial aims to Compare Extra-amniotic dexamethasone infusion with extra-amniotic salin infusion in cervical ripening for labor induction.
Design
Clinical trial with control and intervention group, double – blind, randomized block method (permutation - 4 segmented), phase 3, sample size of 60
Settings and conduct
Sampling takes place in Amiralmomenin hospital.
Participants/Inclusion and exclusion criteria
60 women with gestational age of 37-42 weeks and Bishop Score < 5 will be put into the study if they are submitted.
All patients with uterine anomalies ، placenta previa or placental low lying، Vasapravia، vaginal bleeding in the second and third trimester of pregnancy، Active genital herpes، intra-uterine fetal death) IUFD) and history of uterine classic incision will be excluded from the study.
Intervention groups
Patients will be injected Dexamethasone or normal saline alternately by EASI catheter (In fact, Dexamethasone will be infused into uterine by the extra amniotic injection). The interval between the labor inductions to onset of active phase will be measured and recorded. Every hour after injection، they will be examined for exiting catheter. Bishop score will be determined again after exiting the catheter and both groups will receive oxytocin for induction of labor. The duration of active phases till the second stage of labor ، the first minute Apgar up to fifth minute Apgar will be measured and recorded after birth.
Main outcome variables
Cervical ripening؛ Neonatal Apgar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190107042266N2
Registration date:2020-01-27, 1398/11/07
Registration timing:registered_while_recruiting
Last update:2020-01-27, 1398/11/07
Update count:0
Registration date
2020-01-27, 1398/11/07
Registrant information
Name
Samaneh Lavvaf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
sama_lavvaf@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Extra-amniotic dexamethasone infusion with extra-amniotic salin infusion in cervical ripening for labor induction
Public title
Comparison of Extra-amniotic dexamethasone infusion with extra-amniotic salin infusion in cervical ripening for labor induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age of 37-42 weeks
Candidate for induction of labor
Bishop score of less than 5
Exclusion criteria:
Uterine anomalies
Placenta previa or placental low lying
Authentic History of vaginal bleeding in the second and third trimester of pregnancy
Active genital herpes
Intrauterine fetal death (IUFD)
History of uterine classic incision
Vasa Previa
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
They will randomly be divided into two groups. For randomization, four segmented randomized blocks (permutation) will be used. Will be have two treatment methods. In 4 segmented blocks, two participants will be devoted to intervention group and two participants will be devoted to control group. There will be six different modes for 4 segmented blocks (TTCC, TCTC, TCCT, CCTT, CTCT, CTTC). Designation list will be prepared based on the randomized numbers created by excel with the help of a consultant before initiating the work (between 0 and 1). Rrandomized numbers "0 to 0.16" from the mixture of “TTCC", randomized numbers "0.16 to 0.33" from the mixture of " TCTC", randomized numbers "0.33 to 0.5" from the mixture of “TCCT”, randomized numbers "0.5 to 0.66" from the mixture of "CCTT", randomized numbers "0.66 to 0.83” from the mixture of "CTCT” and randomized numbers “0.83 to 1" from the mixture of "CTTC" will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses will be completed. Another person at the hospital, who is not involved in the trial and not aware of random sequences, will be assigned the participants into two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2019-09-16, 1398/06/25
Ethics committee reference number
IR.SEMUMS.REC.1398.136
Health conditions studied
1
Description of health condition studied
Pregnant wemen
ICD-10 code
Pregnant s
ICD-10 code description
Z33
Primary outcomes
1
Description
Cervical ripening
Timepoint
The measurement of cervix at the beginning of the study and before initiation of the intervention (until 6 hours after initiation of the study) till the creation of bishop score of five and higher
Method of measurement
Vaginal exam based on Bishop score
Secondary outcomes
1
Description
Neonatal Apgar
Timepoint
First and fifth minutes after birth
Method of measurement
Standard method
Intervention groups
1
Description
Intervention group: Foley catheter (size 26) will be inserted into the cervix. The Foley catheter balloon will be filled with 30 ml of sterile water. 20 mg of dexamethasone will be mixed with sterile water to bring the volume to 20 ml. then the Solution will be infused with normal saline sterile infusion (at a rate of 1 ml/min) into the extra amniotic. Every hour after injection، They are examined for exiting catheter. After exiting catheter ، Bishop score will be determined again and labor induction will be implemented with oxytocin.
Category
Treatment - Drugs
2
Description
Foley catheter (size 26) is inserted into the cervix. The Foley catheter balloon will be filled with 30 ml of sterile water. 20 ml of distilled infused water and then the normal saline sterile infusion will be infused into the exterior amniotic. Every hour after injection، they will be examined for exiting catheter. After exiting catheter ، Bishop score will be determined again and labor induction will be implemented with oxytocin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr Shahrzad Aghaamoo
Street address
Amiralmomenin hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
aghaamoo_shahrzad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Shahrzad Aghaamoo
Street address
Amiralmomenin hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
aghaamoo_shahrzad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr Shahrzad Aghaamoo
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hospital Amiralmomenin, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
aghaamoo_shahrzad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Shahrzad Aghaamoo
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hospital Amir-AlMomenin, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
aghaamoo_shahrzad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Shahrzad Aghaamoo
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hospital Amir-AlMomenin, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
aghaamoo_shahrzad@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available