Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss

NCT04637373 | Unknown DMC

• 1 other identifier: 0178-19-ASF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Retained Products of Conception; Intrauterine Adhesion

Keywords

intrauterine adhesions; Hysteroscopy; Retained Products of Conception

Outcome Measures

Primary Outcomes (1)

• the occurrence of Retained products of conception following suction curettage.

  at the end of suction curettage procedure

Secondary Outcomes (1)

• the occurrence of intra uterine adhesions following targeted suction curettage

  on follow-up office hysteroscopy, 5-6 months after the primary procedure

Study Arms (1)

the group

EXPERIMENTAL

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

Interventions

Hysteroscopy DIAGNOSTIC_TEST

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

the group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• incomplete and complete abortions, gestational age\>13 weeks of gestation, suspected molar pregnancy and patients' contraindications for general anesthesia.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Shamir Medical Center

Be’er Ya‘aqov, 7300000, Israel

RECRUITING

MeSH Terms

Conditions

Gynatresia

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Omer Moore, M.D

CONTACT

+972505191242; omer.moore@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Omer Moore

Model Details: This prospective descriptive study is taking place in a single university affiliated medical center.

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: November 19, 2020
• Study Start: July 1, 2019
• Primary Completion: November 4, 2020
• Study Completion: December 31, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

IL (1)