Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss

Intrauterine Adhesion Clinical Trial

Official title:

Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss: Does it Reduce Retained Products of Conception and Postoperative Intrauterine Adhesions?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04637373
• Other study ID #: 0178-19-ASF
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2020
• Source: Assaf-Harofeh Medical Center
• Contact: Omer Moore, M.D
• Phone: +972505191242
• Email: omer.moore[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Intrauterine Adhesion
• Retained Products of Conception
• Tissue Adhesions

Intervention

Diagnostic Test:
• Hysteroscopy
adding Hysteroscopy before and after suction curettage for early missed abortion to define the wall of implantation and look for retained products of conception

Locations

Country	Name	City	State
Israel	Shamir Medical Center	Be'er Ya'aqov

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the occurrence of Retained products of conception following suction curettage.		at the end of suction curettage procedure
Secondary	the occurrence of intra uterine adhesions following targeted suction curettage		on follow-up office hysteroscopy, 5-6 months after the primary procedure