Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309927
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-03-07
Brief Title:
Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss Miscarriage
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss Miscarriage
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Non-blinded prospective randomized study 100 women diagnosed with early pregnancy loss up to 10 gestational weeks who opted for surgical management after being offered the options of conservative management and medical treatment will be recruited
Qualifying patients will sign an informed consent form and will be randomly assigned to the two arms of the study
1 Surgical uterine evacuation by the traditional ultrasound-guided suction curettage control group
2 Surgical uterine evacuation by operative hysteroscopy using a tissue removal device study group
The surgical procedure will be determined randomly by computer generated allocation
All surgical procedures will be performed under general anesthesia in an outpatient surgical suite The operative time operative blood loss and intraoperative complications will be recorded by the research team
Following the surgical procedure the patients will be monitored and discharged home as per our departments day-surgery protocol Immediate post-operative complications will be recorded until discharge
One week after the procedure a telephone interview will be conducted to assess any procedure-related complications
A diagnostic hysteroscopy without anesthesia will be scheduled 6 weeks postoperatively to assess for retained products of conception and for intrauterine adhesions The diagnostic hysteroscopy will be performed by a practitioner who will be blinded to the type of surgery performed
6 months after the procedure a telephone questionnaire will be conducted to assess for subsequent pregnancies
Qualifying patients will sign an informed consent form and will be randomly assigned to the two arms of the study
1 Surgical uterine evacuation by the traditional ultrasound-guided suction curettage control group
2 Surgical uterine evacuation by operative hysteroscopy using a tissue removal device study group
The surgical procedure will be determined randomly by computer generated allocation
All surgical procedures will be performed under general anesthesia in an outpatient surgical suite The operative time operative blood loss and intraoperative complications will be recorded by the research team
Following the surgical procedure the patients will be monitored and discharged home as per our departments day-surgery protocol Immediate post-operative complications will be recorded until discharge
One week after the procedure a telephone interview will be conducted to assess any procedure-related complications
A diagnostic hysteroscopy without anesthesia will be scheduled 6 weeks postoperatively to assess for retained products of conception and for intrauterine adhesions The diagnostic hysteroscopy will be performed by a practitioner who will be blinded to the type of surgery performed
6 months after the procedure a telephone questionnaire will be conducted to assess for subsequent pregnancies
Detailed Description:
Early pregnancy loss occurs in 15 of all pregnancies while 10 of women have experienced at least one pregnancy loss The therapeutic options that are available in these cases include surgical termination of pregnancy by suction curettage medical treatment with Misoprostol and conservative management The surgical termination of pregnancy allows for relatively quick termination of the pregnancy and prevention of heavy vaginal bleeding requiring urgent curettage However although this is a common and relatively safe procedure it is associated with risks such as infection residual trophoblastic tissue or retained products of conception RPOC bleeding and uterine perforation In the long term there is a risk of intrauterine adhesions formation which may cause infertility and in severe cases Ashermans syndrome It has been hypothesized that RPOC following suction curettage occur because it is a blind operation Therefore it is now common practice to use ultrasound imaging during andor immediately after the procedure in order to verify that all the pregnancy contents have been removed However despite the use of ultrasound RPOCs are diagnosed in 1 to 10 of these procedures Intrauterine adhesions following suction curettage are another significant risk of these procedures In a study by Hooker et al intrauterine adhesions were found in approximately 20 of suction curettage cases while in women with repeated miscarriages the risk of intrauterine adhesions was even higher Intrauterine adhesions are of critical importance in women of childbearing age as they may cause infertility menstrual disorders and recurrent miscarriages Therefore preventing adhesions or reducing the rate of adhesions after surgical emptying of the uterine cavity is an issue of utmost importance in women of childbearing age Thus in recent years several studies have investigated the use of operative hysteroscopy for surgical evacuation of early pregnancy loss Hysteroscopy allows a visual assessment of the uterine cavity as opposed to a blind suction curettage possibly reducing the rates of RPOC RPOC In addition during hysteroscopy the surgery is limited to the pregnancy implantation site as opposed to the global suction curettage This may allow for reducing the risk of postoperative intrauterine adhesions These advantages of hysteroscopy compared to the blind suction curettage have been previously shown regarding a similar procedure removal of RPOC by hysteroscopy compared to curettage and nowadays it is indeed acceptable to remove RPOC primarily by hysteroscopy Thus it can be hypothesized that operative hysteroscopy for the management of early pregnancy loss compared with suction curettage may be associated with reduced rates of RPOC and postoperative intrauterine adhesions On the other hand operative hysteroscopy does have some disadvantages compared with suction curettage - it requires expensive equipment a slightly longer operative time and skilled surgeons To date few studies mainly case series or small cohort studies have been carried out regarding the use of hysteroscopy for surgical evacuation of early pregnancy loss These studies found that it is an effective feasible and safe operation Weinberg et al used the hysteroscopic tissue removal device for surgical evacuation of early pregnancy loss up to 10th weeks in 10 patients The procedure could be completed in 8 patients and there were no significant complications Bar-on et al bipolar loop resectoscope in 15 women with early pregnancy loss up to 12 weeks without short term complications More recently a multicenter comparative prospective study from France was published by Huchon et al In this study no differences were found in the rate of subsequent pregnancies However this study included patients who were not candidates for hysteroscopy such as patients admitted incomplete abortion To conclude further comparative studies are needed to determine the benefits of operative hysteroscopy in patients with early pregnancy loss In the present study the investigators will perform a prospective comparison between surgical evacuation of early pregnancy loss by surgical hysteroscopy using the tissue removal device method versus the traditional suction curettage The investigators will evaluate both the feasibility and safety both short and long term of the procedures including an assessment of postoperative intrauterine adhesions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None