Management of RPOC After Induced Abortion

NCT ID: NCT04685694

Last Updated: 2022-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Abortion Induced Complicated

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Expectant

No medication is assigned.

Group Type NO_INTERVENTION

No interventions assigned to this group

Medical

SL 800 mcg Misoprostol

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

sl 800 mcg misoprostol

Interventions

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Misoprostol

sl 800 mcg misoprostol

Intervention Type DRUG

Other Intervention Names

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Cytotec

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Eli Sprecher, MD

MD, PhD. Deputy Director Research & Development

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yossi Tzur, MD

Role: STUDY_DIRECTOR

Tel Aviv Medical Center

Locations

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Tel Aviv Medical Center; ,

Tel Aviv, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 16707509 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14747165 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24417417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28891361 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35752301 (View on PubMed)

Other Identifiers

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0444-19-TLV

Identifier Type: -

Identifier Source: org_study_id

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