Comparison of the therapeutic effect of suction curettage and resectoscopy in Cesarean Scar Pregnancy
Design
This phase 3 clinical trial with a control group, with parallel groups, randomized using the Random allocation rule is performed on 60 patients.
Settings and conduct
This randomized clinical trial study is performed on 60 women with Cesarean Scar Pregnancy in Yas Hospital. The sampling method is convenient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient with stable hemodynamic conditions and 18 to 55 years. Criteria for not entering: Withdraw to participation.
Intervention groups
In the curettage suction group, the cervix is opened using a special instrument to pass through a hysteroscope and other necessary instruments. In hysteroscopy, a telescope-like device is inserted into the cervix through the cervix. The doctor then examines the uterus and uterine walls. This device enters the lower part of the uterus through the cervical canal. Carbon dioxide gas or certain solutions are then transferred to the uterine cavity. This gas or solution opens the uterine cavity and enables the doctor to thoroughly examine the inside of the uterus. Then his surgery is performed under the guidance of abdominal ultrasound with hysteroscopy. In the resectoscopy hysteroscope group, cervical preparation is performed with cervical softening suppositories before surgery. Unipolar or bipolar cutter energy is used for tissue cutting. Fluids are used to fill the uterine cavity. In this method, the patient undergoes ultrasound, hysteroscopy and resectoscopy of ectopic pregnancy.
Main outcome variables
BHCG titration, Hemoglobin level, Number of hospitalization days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150105020558N4
Registration date:2022-03-26, 1401/01/06
Registration timing:prospective
Last update:2022-03-26, 1401/01/06
Update count:0
Registration date
2022-03-26, 1401/01/06
Registrant information
Name
Mahbod Ebrahimi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8882 7794
Email address
maebrahimi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect of suction curettage and resectoscopy in women with cesarean scar pregnancy
Public title
The therapeutic effect of suction curettage and resectoscopy in cesarean scar pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with stable hemodynamic conditions
Patient age 18 to 55 years
Exclusion criteria:
Withdraw to participation
Age
From 18 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: First, 30 letters A and 30 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (curettage suction) or B (hysteroscope resectoscopy) are determined by a lot.
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
Ethical Commette of Tehran University OF Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences, School of Medicine, Pour Sina Ave., Qods Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2022-02-21, 1400/12/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1397
Health conditions studied
1
Description of health condition studied
Ectopic pregnancy
ICD-10 code
O00
ICD-10 code description
Ectopic pregnancy
Primary outcomes
1
Description
BHCG titration
Timepoint
Several times, 48 hours after surgery, then once a week until it is negative
Method of measurement
Blood sampling
2
Description
Hemoglobin level
Timepoint
Twice, 6 hours and 12 hours after surgery
Method of measurement
Blood sampling
Secondary outcomes
1
Description
Number of hospitalization days
Timepoint
Once, at the end of the hospitalization
Method of measurement
With patient' s medical records
Intervention groups
1
Description
Intervention group: In the curettage suction group, the patient is placed under local anesthesia or light general anesthesia with a mask. After anesthesia, the cervix is opened using a special instrument to pass through a hysteroscope and other necessary instruments. In hysteroscopy, a telescope-like device is inserted into the cervix through the cervix. The doctor then examines the uterus and uterine walls. This device enters the lower part of the uterus through the cervical canal. Carbon dioxide gas or certain solutions are then transferred to the uterine cavity. This gas or solution opens the uterine cavity and enables the doctor to thoroughly examine the inside of the uterus. Then his surgery is performed under the guidance of abdominal ultrasound with hysteroscopy.
Category
Treatment - Surgery
2
Description
Intervention group: In the resectoscopy hysteroscope group, cervical preparation is performed with cervical softening suppositories before surgery. Unipolar or bipolar cutter energy is used for tissue cutting. Fluids are used to fill the uterine cavity. In this method, the patient undergoes ultrasound, hysteroscopy and resectoscopy of ectopic pregnancy.