Evaluation of the effects of misoprostol on pre-curettage preparation in molar pregnancy
Design
This study is a double blind clinical trial (parallel design) study.
Samples will be taken from all the patients at Mahdieh and Imam Hossein Hospital
In this study, random allocation of subjects to two intervention and treatment groups was performed using Balanced block randomization technique.
Preparation of random assignment sequences of individuals and their enclosure in sealed envelopes, numbered with a 5-digit serial number, was performed by a third party who had no role in the design of the study.
All envelopes (150 envelopes) were a random 5-digit serial number that was opened immediately after completion of baseline information and trials and assigned individuals to the intervention group (misoprostol) or control group.
Settings and conduct
This study is a double blind randomized clinical trial conducted in Mahdieh and Imam Hossein hospitals. In this double-blind study, the researcher and the clinical caregivers of the patient were unaware of the type of intervention and the preparation of random allocation sequences for individuals and their placement in sealed envelopes and Numbered with a 5-digit serial number, performed by a third party who did not participate in the study design.
Participants/Inclusion and exclusion criteria
Inclusion criteria include molar pregnancy.
Exclusion criteria include a history of allergy to prostaglandins
Intervention groups
Intervention group (n = 75) (misoprostol recipient with a dose of 400 μg vaginal pre-suction curettage) and non-intervention group (n = 75) (curettage suction treatment and placebo prior vaginal delivery). They will be randomly selected from the studied samples.
Main outcome variables
Use of Misoprostol before Curettage in Molar Pregnancy for Cervical Preparation and its Softness to Reduce the Probability of Cervical Injury
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200216046519N1
Registration date:2020-03-11, 1398/12/21
Registration timing:retrospective
Last update:2020-03-11, 1398/12/21
Update count:0
Registration date
2020-03-11, 1398/12/21
Registrant information
Name
Yekta Parsa
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 2365
Email address
yektaparsa@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2020-02-09, 1398/11/20
Trial completion date
2020-03-20, 1399/01/01
Scientific title
Effects of using misoprostol for cervical ripening in molar pregnancy, A Randomized Controlled Trial Study
Public title
Evaluation of misoprostol use for cervical preparation in molar pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with molar pregnancy who are candidates for termination of pregnancy
Exclusion criteria:
They are allergic to prostaglandins
Age
No age limit
Gender
Female
Phase
1
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
75
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were divided into two groups of intervention and current treatment using Balanced block randomization technique
Preparation of random assignment sequences of individuals and their enclosure in sealed envelopes, numbered with a 5-digit serial number, was performed by a third party who had no role in the design of the study.
All envelopes (150 envelopes) were a random 5-digit serial number that was opened immediately after completion of baseline information and trials and assigned individuals to the intervention group (misoprostol) or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in this study and those in clinical care and the researcher were unaware of the type of intervention performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences, Ethics Committee for Biomedical Research
Street address
1, No. 1, Alley of Shade, Dashtyar St., East Sarvestan Street, Elahieh Ave.
City
Tehran
Province
Tehran
Postal code
1964713453
Approval date
2019-09-01, 1398/06/10
Ethics committee reference number
IR.SBMU.MSP.REC.1398.530
Health conditions studied
1
Description of health condition studied
Molar Pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Age of a small and independent variable - Gestational age of a small and independent variable - Parity of a small and independent variable - Uterine size of a small and independent variable - Bleeding during and after K. Quantitative and dependent variable drainage - Long-term variable and dependent variable of operation Quantitative and dependent variables of dilators
Timepoint
.
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pregnant mothers who received corticosteroid misoprostol at a dose of 400 microgram before suction
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
yekta Parsa
Street address
Fadayian Eslam St, Shoush Square, Tehran
City
Tehran
Province
Tehran
Postal code
1964713453
Phone
+98 21 5506 2654
Email
yektaparsa@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
yekta parsa
Street address
1, No. 1, Alley of Shade, Dashtyar St., East Sarvestan Street, Elahieh Ave.
City
Tehran
Province
Tehran
Postal code
1964713453
Phone
+98 21 2200 2365
Email
yektaparsa@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?