Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss

NCT ID: NCT04637373

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retained Products of Conception Intrauterine Adhesion

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

intrauterine adhesions Hysteroscopy Retained Products of Conception

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

This prospective descriptive study is taking place in a single university affiliated medical center.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Hysteroscopy

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Assaf Harofeh MC

Omer Moore

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shamir Medical Center

Be’er Ya‘aqov, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Omer Moore, M.D

Role: CONTACT

Phone: +972505191242

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Omer Moore, M.D

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0178-19-ASF

Identifier Type: -

Identifier Source: org_study_id