Comparison of the effect of misoprostol and misoprostol with Foley cervical catheter for termination of pregnancy in women undergoing previous cesarean section in the second trimester of pregnancy
Comparison of the effect of misoprostol and misoprostol with Foley cervical catheter for termination of pregnancy in women undergoing previous cesarean section in the second trimester of pregnancy
Design
A controlled clinical trial, with parallel, randomized groups, on 82 patients. Excel software generated random numbers were used for randomization.
Settings and conduct
This study will be performed in the maternity ward of Umm Al-Banin and Ghaem hospitals in Mashhad. No blinding was performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: history of previous cesarean section, gestational age of 15-28 weeks, intact membranes, no vaginal bleeding, desire to enter the study.
Non-inclusion criteria: Hypersensitivity to prostaglandins, cervical stenosis, history of cesarean section more than three times
Intervention groups
Control group: receiving sublingual misoprostol.
Intervention group: Receiving sublingual misoprostol with Foley catheter number 16
Main outcome variables
Duration from the beginning of the intervention to vaginal delivery, the rate of vaginal delivery in less than 24 hours, the number of misoprostol doses
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200608047685N3
Registration date:2022-04-30, 1401/02/10
Registration timing:registered_while_recruiting
Last update:2022-04-30, 1401/02/10
Update count:0
Registration date
2022-04-30, 1401/02/10
Registrant information
Name
Elaheh Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3273 5002
Email address
mansourie94150@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of misoprostol and misoprostol with Foley cervical catheter for termination of pregnancy in women undergoing previous cesarean section in the second trimester of pregnancy
Public title
Comparison of the effect of misoprostol alone and misoprostol with Foley catheter in termination of pregnancy in the second trimester
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of previous cesarean section
Gestational age 15-28 weeks
Intact membrane
No vaginal bleeding
Willingness to enter the study
Exclusion criteria:
Allergy to prostaglandins
Cervical Stenosis
A history of more than three cesarean sections
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Excel software will be used to assign people to the control and intervention group. In this way, random codes prepared by Excel software are written as A / B codes on separate sheets. Each sheet is placed separately in an envelope so that the code inside it is not recognizable. With the referral of each eligible patient and after obtaining informed consent, an envelope is taken out and the patient is treated according to the code inside the envelope (code A for the control group and code B for the intervention group).
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
Ghoreishi building; Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
1234567890
Approval date
2021-12-28, 1400/10/07
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.655
Health conditions studied
1
Description of health condition studied
Disposal of vaginal products after previous cesarean section in the second trimester of pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Duration from the beginning of the intervention to vaginal delivery
Timepoint
During the intervention
Method of measurement
By the hour and with the help of vaginal examination by hand
Secondary outcomes
1
Description
Vaginal delivery in less than 24 hours
Timepoint
From the beginning of the intervention until 24 hours later
Method of measurement
Per hour and using a questionnaire
2
Description
Number of doses of misoprostol
Timepoint
During the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: cases with fetus with FHR receive 200 micrograms of sublingual misoprostol every three hours (maximum 5 doses) until the onset of effective uterine contractions (at least 3 contractions in 10 minutes) or expulsion of pregnancy products and cases with IUFD receive half of this dose. If pregnancy products are not excreted within 24 hours of the intervention, the same protocol will be repeated for the patient. In addition to receiving sublingual misoprostol, the research units in this group will also receive Foley catheter number 16.
Category
Treatment - Drugs
2
Description
cases with fetus with FHR receive 200 micrograms of sublingual misoprostol every three hours (maximum 5 doses) until the onset of effective uterine contractions (at least 3 contractions in 10 minutes) or expulsion of pregnancy products and cases with IUFD receive half of this dose. If pregnancy products are not excreted within 24 hours of the intervention, the same protocol will be repeated for the patient.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Masoumeh Mirtaimouri
Street address
Ghaem Hospital, AhmadAbad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0001
Fax
+98 51 3845 3239
Email
b.ghaem@mums.ac.ir
Web page address
https://quaem.mums.ac.ir/
2
Recruitment center
Name of recruitment center
Ommolbanin Hospital
Full name of responsible person
Masoumeh Mirtaimouri
Street address
At the corner of Ayatollah Behjat .16, Zarrineh intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١۴۴٧٣۴٧۶٧
Phone
+98 51 3223 1061
Fax
Email
oah@mums.ac.ir
Web page address
https://woman.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayor Mobarhan
Street address
Ghoraish Street, Doctora crossroad
City
Mashhad
Province
South Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
GhayourM@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
Masoumeh Mirtaimouri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
At the corner of Ayatollah Behjat .16, Zarrineh intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
1234567890
Phone
+98 915 310 6875
Email
Mirtaimourim@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Mirteimori
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
At the corner of Ayatollah Behjat 16, Zarrineh Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
1234567890
Phone
+98 915 310 6875
Email
Mirteimorim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Abbasi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
At the corner of Ayatollah Behjat 16, Zarrineh Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
1234567890
Phone
+98 915 519 1068
Email
Abbasimaryam987@gmail.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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available