Management of RPOC After Induced Abortion

NCT04685694 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 0444-19-TLV
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abortion Induced Complicated

Keywords

RPOC, induced abortion, misoprostol

Outcome Measures

Primary Outcomes (1)

• RPOC rate

  RPOC rate in repeat ultrasound scan performed 5 weeks after randomization

  2 months

Secondary Outcomes (2)

• Adhesions

  2 months

• Bleeding

  2 months

Study Arms (2)

Expectant

NO INTERVENTION

No medication is assigned.

Medical

EXPERIMENTAL

SL 800 mcg Misoprostol

Drug: Misoprostol

Interventions

Misoprostol DRUG

sl 800 mcg misoprostol

Also known as: Cytotec

Medical

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \< age \< 45 year old
• Thick irregular endometrium \>12 mm on trans-vaginal ultrasound

You may not qualify if:

• Endometritis
• Cervical opening \> 1 cm
• Uterine abnormalities
• Contraindication to Misoprostol treatment

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center; ,

Tel Aviv, 64239, Israel

Location

Related Publications (5)

• 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. doi: 10.1136/bmj.38828.593125.55. Epub 2006 May 17.

  PMID: 16707509 BACKGROUND

• 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. doi: 10.1093/humrep/deh049.

  PMID: 14747165 BACKGROUND

• 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.

  PMID: 24417417 BACKGROUND

• 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.

  PMID: 28891361 BACKGROUND

• Tzur Y, Berkovitz-Shperling R, Goitein Inbar T, Bar-On S, Gil Y, Levin I, Cohen A. Expectant vs medical management for retained products of conception after medical termination of pregnancy: a randomized controlled study. Am J Obstet Gynecol. 2022 Oct;227(4):599.e1-599.e9. doi: 10.1016/j.ajog.2022.06.025. Epub 2022 Jun 23.

  PMID: 35752301 DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Yossi Tzur, MD

  Tel Aviv Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. Deputy Director Research & Development

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: December 28, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 years
• Access Criteria: for research purposes only

Locations

IL (1)