Management of RPOC After Induced Abortion

Abortion Induced Complicated Clinical Trial

— RPOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04685694
• Other study ID #: 0444-19-TLV
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: May 2022
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion Induced Complicated

Intervention

Drug:
• Misoprostol
sl 800 mcg misoprostol

Locations

Country	Name	City	State
Israel	Tel Aviv Medical Center; ,	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (4)

Anteby M, Many A, Ashwal E, Yogev Y, Shinar S. Risk factors and complications of manual placental removal after vaginal delivery - how common are additional invasive procedures? J Matern Fetal Neonatal Med. 2019 Feb;32(3):384-388. doi: 10.1080/14767058.2017.1379071. Epub 2017 Sep 19. — View Citation

Ashwal E, Melamed N, Hiersch L, Wiznitzer A, Yogev Y, Peled Y. The incidence and risk factors for retained placenta after vaginal delivery - a single center experience. J Matern Fetal Neonatal Med. 2014 Dec;27(18):1897-900. doi: 10.3109/14767058.2014.883374. Epub 2014 Feb 4. — View Citation

Bagratee JS, Khullar V, Regan L, Moodley J, Kagoro H. A randomized controlled trial comparing medical and expectant management of first trimester miscarriage. Hum Reprod. 2004 Feb;19(2):266-71. — View Citation

Trinder J, Brocklehurst P, Porter R, Read M, Vyas S, Smith L. Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial). BMJ. 2006 May 27;332(7552):1235-40. Epub 2006 May 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RPOC rate	RPOC rate in repeat ultrasound scan performed 5 weeks after randomization	2 months
Secondary	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).	2 months
Secondary	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).	2 months