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Comparison of induction of abortion in the first trimester using misoprostol and misoprostol with estrogen priming

Protocol summary

Summary
Objective: To determine and compare the induction of abortion in the first trimester using misoprostol and misoprostol with estrogen priming. Design: This study will be conducted in two-way fashion. The patient and person who will check the symptoms and consequences of taking the drug will be unaware of the type of drug used. The result will be expressed according to the code of each drug. Randomized randomization is blocked with 10 blocks, and patients will be assigned to the appropriate group according to the order of referral in order of assignment to each group. In the misoprostol recipient, this medication at 800 μg every 8 hours (4 pills 200 μg) will be placed vaginal in the posterior forronix. In the other group, the first dose of misoprostol, oral estrogen valerate with a dose of 2 mg to the patient The data will continue to be similar to the previous one. Entry Criteria: Pregnant women aged 6 weeks to 14 weeks have two Missed Abortion ultrasounds. Exit criteria: history of cesarean section, renal or hepatic disease, pulmonary disease, coagulation disorders, evidence or history of thromboembolism, prostaglandin allergy, cigarette smoking, water repellent, vaginal bleeding, history of thromboembolism, intrauterine device, any amount of natural nursing tests Blood pre-treatment (CBC, liver function tests, and liver function tests including blood urea, creatinine), uncontrolled seizure disorders. Study size: 100 patients, 50 patients in the study group and 50 controls

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017070934981N1
Registration date: 2017-07-16, 1396/04/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-16, 1396/04/25
Registrant information
Name
Maryam Esmaeilpour
Name of organization / entity
Univercity
Country
Iran (Islamic Republic of)
Phone
+98 54 3339 5083
Email address
m.esmaeilpour@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Government , Zahedan University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of induction of abortion in the first trimester using misoprostol and misoprostol with estrogen priming
Public title
The effect of estrogen and misoprostol on abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Entry Criteria: Pregnant women aged 6 weeks to 14 weeks have two Missed Abortion ultrasounds. Exit criteria: history of cesarean section, history of adrenal, kidney or liver disease, pulmonary disease, coagulation disorders, evidence of thromboembolic events, prostaglandin sensitivity, smoking, water repellent, vaginal bleeding, history of thromboembolism, estrogen dependent cancers Breast and genital system), intrauterine device, any normal amount of blood. Pre-treatment blood tests include CBC, liver and kidney function tests including blood urea, creatinine, albumin, globulin, liver enzymes, electrolytes, severe anemia, disorders Uncontrolled seizures
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Zahedan University of Medical Sciences
Street address
University Street, Dr Hasabe Square
City
Zahedan
Postal code
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
IR.ZAUMS.REC.1396.9

Health conditions studied

1

Description of health condition studied
Abortion
ICD-10 code
O02.1
ICD-10 code description
Early fetal death with retention of dead fetus

Primary outcomes

1

Description
Successful abortion
Timepoint
4 hours after disposal of pregnancy
Method of measurement
Based on the amount of pregnancy residues in ultrasound after excretion of pregnancy products

Secondary outcomes

1

Description
Misoprostol side effects
Timepoint
Immediately after starting treatment
Method of measurement
Based on completed patient questionnaire

Intervention groups

1

Description
In this study, the aim of this study was to examine the induction of abortion in the first trimester using misoprostol and misoprostol with estrogen priming, randomly divided into two groups receiving misoprostol and misoprostol with estrogen priming. In the misoprostol-containing group, this medication at 800 μg every 8 hours (4 pills 200 μg) will be placed vaginal in the posterior foreskin (up to a maximum dose of 2400 μg), followed by side effects of fever, sweating, fatigue, Nausea, vomiting, abdominal pain ... and the time taken to remove tissue and will be recorded in the patient's case. Four hours after the removal of the tissue, ultrasound is performed for the patient and if the pregnancy remains below 10 mm, the abortion is considered successful and if the remains are more than 10 mm, the curettage will be performed for the patient. . In the misoprostol group with estrogen priming, we will also work on the misoprostol group, with the exception that in this group, the first dosage of misoprostol will be given to the patient with oral estrogen valerima with a dose of 2 mg and the study will continue to be similar to that of the previous group. were.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali ebn Abi Taleb Hospital, Zahedan
Full name of responsible person
Maryam Esmaeilpour
Street address
Ali ebn Abi Taleb Hospital, Khalij Fars Bolvard
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Maryam Esmeilpour
Street address
University Street. Dr Hasabi's Square
City
zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Esmaeilpour
Position
Assistant of Obstetrics and Gynecology
Other areas of specialty/work
Street address
University Street, Dr Hasabe Square
City
Zahedan
Postal code
Phone
+98 543329557185
Fax
Email
esmailpoorm2@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Batoul Teymouri
Position
Assistant Professor
Other areas of specialty/work
Street address
Ali ebn Abi Taleb Hop
City
Zahedan
Postal code
Phone
+98 543329557185
Fax
Email
teimoorib@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Esmaeilpour
Position
Assistant of Obstetrics and Gynecology
Other areas of specialty/work
Street address
University Street, Dr Hasabe Square
City
Zahedan
Postal code
Phone
+98 543329557185
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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