Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss

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

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.

Study Overview

• Status: Unknown
• Conditions: Intrauterine Adhesion; Retained Products of Conception
• Intervention / Treatment: Diagnostic test: Hysteroscopy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omer Moore, M.D; Phone Number: +972505191242; Email: omer.moore@gmail.com

Study Locations

• Israel
  • Be'er Ya'aqov, Israel, 7300000
    • Recruiting
    • Shamir Medical Center
    • Contact: Omer Moore, M.D; Phone Number: +972505191242; Email: omer.moore@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: the group; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the occurrence of Retained products of conception following suction curettage.	at the end of suction curettage procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
the occurrence of intra uterine adhesions following targeted suction curettage	on follow-up office hysteroscopy, 5-6 months after the primary procedure

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): November 4, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: November 15, 2020
• First Submitted That Met QC Criteria: November 15, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 15, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Hysteroscopy; intrauterine adhesions; Retained Products of Conception
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Pregnancy Complications; Cicatrix; Tissue Adhesions; Abortion, Spontaneous
• Other Study ID Numbers: 0178-19-ASF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Yes, going to publish, not deciced on which paper yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No