Abortion Induced Complicated
Conditions
Keywords
RPOC, induced abortion, misoprostol
Brief summary
Randomized trial comparing expectant management and medical management in women diagnosed with retained products of conception after first trimester induced abortion
Detailed description
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.
Interventions
DRUGMisoprostol
sl 800 mcg misoprostol
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RPOC rate | 2 months | RPOC rate in repeat ultrasound scan performed 5 weeks after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adhesions | 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). |
| Bleeding | 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). |
Countries
Israel
Outcome results
None listed