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Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss

S

Shamir Medical Center (Assaf-Harofeh)

Status

Unknown

Conditions

Retained Products of Conception
Intrauterine Adhesion

Treatments

Diagnostic Test: Hysteroscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT04637373
0178-19-ASF

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

the group
Experimental group
Description:
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.
Treatment:
Diagnostic Test: Hysteroscopy

Trial contacts and locations

1

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Central trial contact

Omer Moore, M.D

Data sourced from clinicaltrials.gov

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