Skip to main content
OpenTrials
Completed

NCT Number: NCT04685694

Management of RPOC After Induced Abortion

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abortion Induced Complicated

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Tel Aviv Medical Center; ,

Tel Aviv, 64239, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

sl 800 mcg misoprostol

Other names: Cytotec

Primary outcomes

  1. RPOC rate

    Time frame: 2 months

    RPOC rate in repeat ultrasound scan performed 5 weeks after randomization

Secondary outcomes

  1. Adhesions

    Time frame: 2 months

    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).

  2. Bleeding

    Time frame: 2 months

    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).

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Official study title

Expectant Management Versus Medical Management of Retained Products of Conception After Induced Abortion

Acronym: RPOC

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 28, 2020
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.