Management of RPOC After Induced Abortion

Tel-Aviv Sourasky Medical Center141 enrolled

Overview

Randomized trial comparing expectant management and medical management in women diagnosed with retained products of conception after first trimester induced abortion

An open label randomized controlled trial (RCT) of all women diagnosed with retained product of conception (RPOC) after first trimester medical TOP in a single university affiliated medical center. All consecutive women who underwent medical TOP by mifepristone and misoprostol at gestational age under 63 days from last menstrual period and were diagnosed with RPOC in a routine 3-week ultrasound follow-up are offered to participate. RPOC is defined as thick irregular endometrium (over 12 mm) with positive Doppler flow. Following recruitment, patients are randomized into either expectant arm or medical arm (800 mcg misoprostol). The primary outcome measure is RPOC rate in repeat ultrasound scan performed 5 weeks after randomization.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

141

Conditions

Abortion Induced Complicated

Interventions

MisoprostolDRUG

sl 800 mcg misoprostol

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18 \< age \< 45 year old * Thick irregular endometrium \>12 mm on trans-vaginal ultrasound Exclusion Criteria: * Endometritis * Cervical opening \> 1 cm * Uterine abnormalities * Contraindication to Misoprostol treatment

Locations (1)

Tel Aviv Medical Center; ,

Tel Aviv, Israel

Outcomes

Primary Outcomes

RPOC rate

RPOC rate in repeat ultrasound scan performed 5 weeks after randomization

Time frame: 2 months

Secondary Outcomes

Adhesions

According to our study protocol all women with persistent products of conception diagnosed on repeated ultrasound examination undergo hysteroscopy. During hysteroscopy, assessment of the uterine cavity including intrauterine adhesion formation will be performed. Intrauterine adhesions will be classified according to the American Society for Reproductive Medicine (ASRM), based on the extent of cavity involvement (\<1/3; 1/3 to 2/3, \>2/3) and the type of adhesion seen (filmy, filmy and dense, dense).

Time frame: 2 months

Bleeding

Bleeding pattern will be assessed via questionnaire upon recruitment and follow up visits. Bleeding will be characterized by its pattern (regular, intermenstrual) and quantity (normal, hypomenorrhoea, menorrhagia).

Time frame: 2 months

Data from ClinicalTrials.gov

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