Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss
Primary Purpose
Retained Products of Conception, Intrauterine Adhesion
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hysteroscopy
Sponsored by
About this trial
This is an interventional prevention trial for Retained Products of Conception focused on measuring intrauterine adhesions, Hysteroscopy, Retained Products of Conception
Eligibility Criteria
Inclusion Criteria:
- Women aged 18-40 years who were admitted to the gynecology emergency department at our institution with early miscarriage up to 12 weeks and 6 days of gestation, and choose surgical evacuation over medical treatment
Exclusion Criteria:
- incomplete and complete abortions, gestational age>13 weeks of gestation, suspected molar pregnancy and patients' contraindications for general anesthesia.
Sites / Locations
- Shamir Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
the group
Arm Description
Women aged 18-40 years who admit to the gynecology emergency department at our institution with early miscarriage up to 12 weeks and 6 days of gestation, and choose surgical evacuation over medical treatment, are having Hysteroscopy assisted suction curettage as detailed previously. retained products of conception found at the end of the procedure, and intrauterine adhesions found on follow up are compared to the data in the literature.
Outcomes
Primary Outcome Measures
the occurrence of Retained products of conception following suction curettage.
Secondary Outcome Measures
the occurrence of intra uterine adhesions following targeted suction curettage
Full Information
NCT ID
NCT04637373
First Posted
November 15, 2020
Last Updated
November 15, 2020
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04637373
Brief Title
Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss
Official Title
Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss: Does it Reduce Retained Products of Conception and Postoperative Intrauterine Adhesions?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
November 4, 2020 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Retained products of conception (RPOC) and intrauterine adhesions (IUA) may occur following suction curettage for early miscarriage and cause secondary infertility, recurrent pregnancy loss and pregnancy complications. The aim of this study is to investigate whether adding hysteroscopy to suction curettage reduces the rates of RPOC and IUA.
Detailed Description
This is a descriptive, prospective study. Women aged 18-40 years admitted for surgical evacuation in cases of early missed abortion in a single university affiliated medical center are being recruited. All procedures performed under general anesthesia following cervical ripening with vaginal Misoprostol.
Before the evacuation, a diagnostic hysteroscopy was performed to identify the pregnancy's implantation wall. Subsequently, ultrasound guided suction and curettage directed to the implantation wall is done. Finally, the uterine cavity is evaluated by hysteroscopy for RPOC. Participants are scheduled for follow-up diagnostic office hysteroscopy 2 months after termination of pregnancy for assessment of IUA and RPOC. However, due to restrictions on elective surgical procedures brought on by the Covid-19 pandemic, the follow-up hysteroscopy examination was postponed until 5 to 6 months after termination of pregnancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retained Products of Conception, Intrauterine Adhesion
Keywords
intrauterine adhesions, Hysteroscopy, Retained Products of Conception
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This prospective descriptive study is taking place in a single university affiliated medical center.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the group
Arm Type
Experimental
Arm Description
Women aged 18-40 years who admit to the gynecology emergency department at our institution with early miscarriage up to 12 weeks and 6 days of gestation, and choose surgical evacuation over medical treatment, are having Hysteroscopy assisted suction curettage as detailed previously. retained products of conception found at the end of the procedure, and intrauterine adhesions found on follow up are compared to the data in the literature.
Intervention Type
Diagnostic Test
Intervention Name(s)
Hysteroscopy
Intervention Description
adding Hysteroscopy before and after suction curettage for early missed abortion to define the wall of implantation and look for retained products of conception
Primary Outcome Measure Information:
Title
the occurrence of Retained products of conception following suction curettage.
Time Frame
at the end of suction curettage procedure
Secondary Outcome Measure Information:
Title
the occurrence of intra uterine adhesions following targeted suction curettage
Time Frame
on follow-up office hysteroscopy, 5-6 months after the primary procedure
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women aged 18-40 years who were admitted to the gynecology emergency department at our institution with early miscarriage up to 12 weeks and 6 days of gestation, and choose surgical evacuation over medical treatment
Exclusion Criteria:
incomplete and complete abortions, gestational age>13 weeks of gestation, suspected molar pregnancy and patients' contraindications for general anesthesia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omer Moore, M.D
Phone
+972505191242
Email
omer.moore@gmail.com
Facility Information:
Facility Name
Shamir Medical Center
City
Be'er Ya'aqov
ZIP/Postal Code
7300000
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omer Moore, M.D
Phone
+972505191242
Email
omer.moore@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Yes, going to publish, not deciced on which paper yet
Learn more about this trial
Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss
We'll reach out to this number within 24 hrs