Management of RPOC After Induced Abortion

Tel Aviv Sourasky Medical Center

Status and phase: Completed; Phase 4

Conditions: Abortion Induced Complicated

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT04685694

0444-19-TLV

Details and patient eligibility

About

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

Full 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.

Enrollment: 141 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

141 participants in 2 patient groups

Expectant

No Intervention group

Description:

No medication is assigned.

Medical

Experimental group

Description:

SL 800 mcg Misoprostol

Treatment:

Drug: Misoprostol