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Completed

NCT Number: NCT02867202

Adjuvant Therapy for Intrauterine Adhesions Between Two Groups

This study was taken out to compare two mechanical devices (intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter) in the therapy for intrauterine adhesions after hysteroscopic adhesiolysis. Participates were assigned into two groups by randomly.

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Key information

Conditions

Asherman Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

the 1st Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

About this study

Intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter are both effective in the therapy for intrauterine adhesion.

The Intrauterine Contraceptive Device Plus Foley Catheter are usually inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed two or three month later.

The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate to severe intrauterine adhesion (AFS score ≥5）
  • Agreement to have a second-look hysteroscopy
  • no previous history of hysteroscopic adhesiolysis

Exclusion criteria

  • Minimal adhesion (AFS score<5)
  • Previous hysteroscopic adhesiolysis

Treatment and study plan

intrauterine balloon

Device

After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.

Other names: Cook balloon

Intrauterine Contraceptive Device Plus Foley Catheter

Device

After the completion of hysteroscopic adhesiolysis, Intrauterine Contraceptive Device Plus Foley Catheter were inserted into the uterine cavity. Foley Catheter was removed after three days and Intrauterine Device was removed at the second time of hysteroscopy.

Other names: Intrauterine Device Plus Foley Catheter

Primary outcomes

  1. the AFS Score at Second-look Hysteroscopy

    Time frame: 2 or 3 months after the surgery

    The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Official study title

A Randomized Clinical Trial to Assess the Efficacy of Intrauterine Balloon Compared to Intrauterine Contraceptive Device Plus Foley Catheter in the Therapy for Uterine Adhesion After Hysteroscopic Adhesiolysis

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2016
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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