Protocol summary

Study aim
Comparison of the effect of Misoprostol and Dilapen with Misoprostol during cervical preparation in first and second trimesters. Comparison of the effect of Misoprostol and Dilapen with Misoprostrol on cervical dilatation in first and second trimester abortions.
Design
Clinical trial with control group, with parallel group, double-blind, randomized, phase 3, on 196 patients. R random function of R software was used for randomization.
Settings and conduct
Patients are randomly divided into two groups.The first group of misoprostol is placed 4 hours before surgery and the second group of dilapen is placed 24 hours before surgery and 4 hours before surgery. After general anesthesia, all evaluations of cervical by The blind researcher is done, then the curettage is done and the curettage products are sent for pathology
Participants/Inclusion and exclusion criteria
Inclusion criteria: mothers over the age of 18, a gestational age of less than or equal to 24 weeks based on the date of the last menstrual period (LMP), and an ultrasound of the first 3 months of pregnancy Exclusion criteria: patient dissatisfaction to participate in the study, patients under 18 years of age, contraindications to the use of misoprostol (drug allergy, active asthma, heart disease, renal failure or glaucoma), active genital infection, structural disorders of the uterus and bladder, cancer Cervical and surgical history of cervical cancer
Intervention groups
The first group is received for the preparation of cervical dilapine with misoprostol, and the second group is treated with misoprostol
Main outcome variables
Cervix preparation time Feeling the patient's discomfort based on the five-digit criterion Dilatation and cervical consistency based on the surgeon's examination according to the five-digit criterion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200603047648N1
Registration date: 2020-07-13, 1399/04/23
Registration timing: prospective

Last update: 2020-07-13, 1399/04/23
Update count: 0
Registration date
2020-07-13, 1399/04/23
Registrant information
Name
Naeeme Morovati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 8566 8514
Email address
naeeme.mrv@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Misoprostol and Diplen with Misoprostol in cervical priming in the first and second trimesters
Public title
Mesoprostol and Dilapen in the preparation of the cervix for abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years for mothers Less or equal pregnancy age 24 weeks based on (LMP) and ultrasound of the first 3 months of pregnancy Patient satisfaction to participate in the study Legal permission for abortion is from the relevant authorities
Exclusion criteria:
Patients under 18 years of age Contraindications to the use of misoprostol (drug allergy, active asthma, heart disease, renal failure or glaucoma) Active genital infection Structural disorders of the uterus and bladder Cervical cancer History of cervical surgery
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 196
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random allocation of individuals to two groups of intervention and current treatment was performed using Balanced bloch randomization technique. Using R software to generate random number chains 1 to 6 (the number of possible states for placement in blocks) Until the volume of the sample was reached. Preparation of random allocation sequences of individuals and placing them in sealed envelopes (sealed) and numbered with a 5-digit serial number by the third person who plays a role in designing the study. Has not, has been done
Blinding (investigator's opinion)
Double blinded
Blinding description
In the treatment group, in addition to receiving vaginal diazepam mesoprostol, it is vaginally placed by a specialist doctor, and in the control group, only mesoprostol is received. After the procedure, patients will be examined by 2 blind researchers who do not know to whom dilapen is placed. Who has only used misoprostol. Patients will be examined by two researchers in terms of postoperative complications. The patient will then be hospitalized for side effects after surgery and the consequences of the procedure. The patient's opinion is checked by a student (specific to this task) that the student does not know who received the diplopen and who did not receive it and records all the consequences. In fact, neither the researcher nor the evaluator of the consequences of how patients are divided
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Alborz University Of medical Sciences
Street address
Saffarian Alley, Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2020-05-26, 1399/03/06
Ethics committee reference number
IR.ABZUMS.REC.1399.063

Health conditions studied

1

Description of health condition studied
Medical abortion in first and second trimester
ICD-10 code
O04.80
ICD-10 code description
(Induced) termination of pregnancy with unspecified complications

Primary outcomes

1

Description
Cervical dilatation rate
Timepoint
Before surgery and after general anesthesia
Method of measurement
Examination by a specialist

2

Description
Feeling sick
Timepoint
Before surgery and after general anesthesia
Method of measurement
Examination by a specialist doctor based on a five-digit criterion (without discomfort, with discomfort, relatively uncomfortable, very uncomfortable, unbearable)

3

Description
Servicing preparation time
Timepoint
After receiving the drug until the start of surgery
Method of measurement
Examination by a specialist

Secondary outcomes

1

Description
Side effects( include vaginal pain, pressure on the bladder, diarrhea and vaginal bleeding, and incomplete miscarriage.)
Timepoint
Before general anesthesia, after the procedure and the patient regained consciousness
Method of measurement
Examination by a specialist doctor, ultrasound (if you have symptoms in favor of incomplete abortion once before discharge)

2

Description
Cervical consistency
Timepoint
Before surgery and after general anesthesia
Method of measurement
Examination by a specialist doctor based on three-digit criteria (according to the surgeon, soft, medium, hard)

Intervention groups

1

Description
Control group: Control group: In the control group, to prepare the cervix, 400 micrograms of misoprostol will be placed vaginally by a gynecologist 4 hours before surgery. Mesoprostol is an analogue of prostaglandin E1, which is the best option for cervical preparation studies in terms of speed, function and cost.
Category
Treatment - Drugs

2

Description
Intervention group: Intervention group: In this group, to prepare the cervix, 24 hours before the surgery, a diplopene is placed vaginally by the obstetrician and gynecologist for the patient. The cervix becomes vaginal). 4 hours before surgery, 400 micrograms of misoprostol will be vaginally placed by a gynecologist (exactly as done for the control group). The synergistic effect of the two can be examined together
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamali Hospital
Full name of responsible person
Bita Badehnoosh
Street address
Alborz university of medical sience, Saffarian Alley, Golshahr
City
Karaj
Province
Alborz
Postal code
4156853445
Phone
+98 26 4158 6658
Email
badehnoosh@abzums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mostafa Ghorbani
Street address
Saffarian Alley, Golshar blvd
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Karaj University of Medical Sciences
Full name of responsible person
Bita Badehnoosh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali hospital ,Kamali Ave, shohada sq, Beheshti blvd
City
Karaj
Province
Alborz
Postal code
4156853445
Phone
+98 26 4158 6658
Email
badehnoosh@abzums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Bita Badehnoosh
Position
Assistant proffesor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alborz university of medical sciences , Saffarian Alley , Golshahr
City
Karaj
Province
Alborz
Postal code
4156853445
Phone
0098 26 4158665
Email
badehnoosh@abzums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Naeeme morovati
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kamali Hospital , Kamali Ave , Shohada Sq , Beheshti Alley
City
Karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3222 2021
Email
naeeme.mrv@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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