Comparative study of the effects of TNG, misoprostol, dexamethasone and Foley catheter with acetaminophen on the process effacement and dilatation in the inactive and active phase of labor
Comparison of the effects of TNG, misoprostol, dexamethasone and Foley catheter on the process labor
Design
A single-blind clinical trial with a control group. Patients are randomly divided into 4 groups according to the above items. 60 patients in each group The method of randomizing the table of random numbers in vital statistics reference books is such that the numbers 1 to 50 belong to the first group, and the numbers 51 to 100 belong to the second group and the numbers 101 to 150 belong to the third group.
Trial phase: It has no validity.
Settings and conduct
Then changes in fetal heart rate, mother's blood pressure, mother's heart rate, mother's breathing rate, random sugar in each group will be recorded before drug injection and 1 hour after the first dose and 2 hours after the first dose. In case of repeating the drugs, up to 3 doses of the above items are measured before and 1 hour and 2 hours after re-administration.The length of the active phase, the type of delivery, the baby's weight and the first and fifth minutes of Apgar and the umbilical cord ABG at the time of the baby's birth are recorded. In the whole study, all possible side effects for the mother and the baby are evaluated and checked very carefully, and if there is a possibility that it is related to the intervention, it is quickly reported to the ethics committee and the plan is temporarily stopped until re-approval.
Participants/Inclusion and exclusion criteria
Gravid 1 with GA > 37 weeks and Bishop score ≤ 4 and singleton pregnancy
Intervention groups
1-Cervical catheter is inserted into cervix.
2-Nitroglycerin: The contents of 400 micro TNG tablets poured into the cervix.
3-Dexamethasone: 8 mg is injected intramuscularly.
4-(Control) Misoprostol: 25 micrograms of misoprostol is placed sublingually.
Main outcome variables
Length of delivery; caesarean section rate; complications during childbirth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180409039247N3
Registration date:2022-12-20, 1401/09/29
Registration timing:prospective
Last update:2022-12-20, 1401/09/29
Update count:0
Registration date
2022-12-20, 1401/09/29
Registrant information
Name
Marjan Ghaemibidgoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 4858
Email address
m_ghaemi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effects of TNG, misoprostol, dexamethasone and Foley catheter with acetaminophen on the process effacement and dilatation in the inactive and active phase of labor
Public title
Comparison of the effect of TNG, misoprostol, dexamethasone and Foley tube along with acetaminophen on the process of dilatation and effusion in childbirth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-40 years old
Gestational age > 37 weeks
Singleton pregnancy
Cephalic presentation
Gravid 1
Exclusion criteria:
Cephalopelvic incompatibility
Maternal medical diseases
Fetal distress
Uterine scar
Sensitivity to studied drugs
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomizing the table of random numbers is vital statistics reference books.
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 in the research of Imam Khomeini hospital complex
Street address
Imam complex, East Bagherkhan street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-11-15, 1401/08/24
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.226
Health conditions studied
1
Description of health condition studied
Increasing the success rate in vaginal delivery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The time interval of hospitalization for the termination of pregnancy until delivery
Timepoint
Every 6 hours
Method of measurement
Minutes
Secondary outcomes
1
Description
Reducing the cesarean rate
Timepoint
At the end of the labor phase
Method of measurement
Has she had a caesarean section?
Intervention groups
1
Description
Intervention group: The content of the 400 micro TNG tablet is diluted with 1 cc of serum and poured into the cervix (repeat after 4 and 6 hours if Bishop does not improve)
Category
Treatment - Drugs
2
Description
Intervention group: 8 mg of dexamethasone is injected intramuscularly (this arm is one time and does not repeat)
Category
Treatment - Drugs
3
Description
Intervention group:The Foley catheter is inserted into the cervix with 500 ml of water (maximum 12 hours). Foley is 16 and the bottle is filled with 30 cc. If it does not turn off, it will automatically turn off after 12 hours.
Category
Treatment - Devices
4
Description
Control group: 25 microns of misoprostol is placed under the tongue (if Bishop does not improve over 4, it is repeated after 6 hours)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-Asr hospital
Full name of responsible person
Fahimeh Ghotbizedeh
Street address
East Bagherkhan
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6116 2365
Email
fghotbizadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences - Research Assistant
Full name of responsible person
Akbar Fotouhi
Street address
Quds St. intersection with Keshavarz Blvd
City
tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 0000
Email
info@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences - Research Assistant
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
Tehran University of Medical Sciences
Full name of responsible person
Fahimeh Ghotbizadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam hospital, East Bagherkhan St.
City
Tehran
Province
Tehran
Postal code
141973314
Phone
+98 21 6119 0000
Email
fghotbizadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fahimeh Ghotbizadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam hospital, East Bagherkhan St.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
fghotbizadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marjan Ghaemibidgoli
Position
Assissted professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Khomeini hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8800 4858
Fax
Email
marjan_ghaemi@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