Comparative study of drug treatment outcomes (OCP and Methergine) in aborted patients with pregnancy remnants
Design
This is a single-blinded randomized clinical trial with a parallel design. This study is randomized, phase 2-3 study will be performed on 80 patients with pregnancy debris. A random number table is used for randomization and participants are assigned to two intervention groups.
Settings and conduct
This study, which will be conducted at Al-Zahra Hospital in Isfahan, is a single-blinded one. In this single-blinded study, participants will be kept blind to the type of drug. Before starting the study, patients are treated with Misoprostol according to the protocol. They enter the study 10 days after receiving Misoprostol according to the inclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years; Forgotten abortion under 20 weeks; Hemoglobin above 10; No contraindications to receiving Methergine or OCP;
Stability of the patient's vital signs at the beginning of the treatment
Exclusion criteria: Active liver disease; Cardiovascular disease; HTN infection; Severe bleeding
Intervention groups
The first intervention group will receive OCP (0.03 mg Ethinylestradiol and 0.15 Desogestrel) daily for 21 days. The second intervention group, patients will receive three times a day (0.25 mg oral Methergine) for 10 days. In addition, in both groupe100 mg oral Doxycycline capsules, every 12 hours for 10 days will be administered.
Main outcome variables
Incidence of infection; Gastrointestinal symptoms, cardiovascular complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220430054708N1
Registration date:2022-05-31, 1401/03/10
Registration timing:prospective
Last update:2022-05-31, 1401/03/10
Update count:0
Registration date
2022-05-31, 1401/03/10
Registrant information
Name
Samira Rafiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3337 0835
Email address
samira.rafiee@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-14, 1401/03/24
Expected recruitment end date
2022-12-15, 1401/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of drug treatment outcomes (OCP and Methergine) in aborted patients with pregnancy remnants
Public title
study of the effect of drug treatment (OCP and Methergine) in patients with pregnancy remnants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Forgotten abortion under 20 weeks
Hemoglobin above 10
No contraindications to receiving Methergine or OCP
Stability of the patient's vital signs at the beginning of the treatment
Exclusion criteria:
Active liver disease
Cardiovascular disease
HTN infection
Advanced neurological disease
Symptoms of infection
Severe bleeding
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method. 80 cards are selected and numbers from 1-80 are inserted on the cards. The cards are placed in an envelope. Two of the design partners take one card out of the envelope each time and announce the card number. Paired numbers are assigned to the intervention group and odd numbers to the control group
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will consciously participate in the study but OCP and methergine will label as A and B. Participants will not know whether the drug is A or B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib St..
City
Isfahan
Province
Kermanshah
Postal code
8174673461
Approval date
2022-03-04, 1400/12/13
Ethics committee reference number
IR.MUI.MED.REC.1400.825
Health conditions studied
1
Description of health condition studied
Placental remnants
ICD-10 code
O03.4
ICD-10 code description
Incomplete spontaneous abortion without complication
Primary outcomes
1
Description
Incidence of infection
Timepoint
At the beginning of the study and one month after the start of the study
Method of measurement
Based on the clinical signs, the fever is mostly equal to 38 degrees Celsius
2
Description
Gastrointestinal symptoms
Timepoint
At the beginning of the study and one month after the start of the study
Method of measurement
visual analogue scale
3
Description
Cardiovascular complications
Timepoint
At the beginning of the study and one month after the start of the study
Method of measurement
Clinical signs
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive OCP (0.03 mg Ethinylestradiol and 0.15 Desogestrel) daily for 21 days. In addition, 100 mg oral Doxycycline capsules every 12 hours for 10 days will be administered.
Category
Treatment - Drugs
2
Description
The second intervention group, patients will receive three times a day (0.25 mg oral Methergine) for 10 days. In addition, 100 mg oral Doxycycline capsules every 12 hours for 10 days will be administered.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Samira Rafiei
Street address
Al-Zahra Educational and Medical Center, Safa Boulevard,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
samira.rafiee@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shahin Sheyrani
Street address
Vice Chancellor for Research and Technology,Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Samira Rafiei
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan University of Medical Sciences, Hezar Jarib St..
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
samira.rafiee@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Elham Naghshineh
Position
Faculty member of Isfahan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan University of Medical Sciences, Hezar Jarib St..
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
Naghshineh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Samira Rafiei
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan University of Medical Sciences, Hezar Jarib St..
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
samira.rafiee@ymail.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