Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss

Not Applicable

• Conditions: Intrauterine Adhesion; Retained Products of Conception
• Interventions: Diagnostic Test: Hysteroscopy

• Registration Number: NCT04637373
• Lead Sponsor: Assaf-Harofeh Medical Center

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.

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 Timeline

• Study Start: 2019-07-01
• Status Verified: 2020-11
• Primary Completion: 2020-11-04
• Study First Submitted: 2020-11-15
• Study First Submitted QC: 2020-11-15
• Last Update Submitted: 2020-11-15
• Study First Posted: 2020-11-19
• Last Update Posted: 2020-11-19
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
the group	Hysteroscopy	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.

Primary Outcome Measures

Name	Time	Method
the occurrence of Retained products of conception following suction curettage.	at the end of suction curettage procedure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shamir Medical Center; 🇮🇱 Be'er Ya'aqov, Israel