Postoperative Intermittent Intrauterine Balloon Dilatation Therapy.

NCT03131596 | Completed Results

• 1 other identifier: 2016FXHEC-KY036
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, randomized, controlled study, the investigators wish to determine the efficacy of intrauterine balloon (IUB) dilatation in the prevention of adhesion reformation when compared with the conventional management.

Conditions

Intrauterine Adhesion

Keywords

Intrauterine Adhesion; Hysteroscopy; Intrauterine balloon; Reformation; Prevention

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Adhesion Reformation (American Fertility Society Score of Greater Than 0) 8 Weeks Later After the Index Surgery

  The American Fertility Society (AFS) score ranges from 0-12, while represented the severity of the adhesions. Mild 1-4, Moderate 5-8, Severe 9-12. The lower the AFS score is, the better the prognosis the patient is. When the surgery was finished the AFS score should be 0. The reformation of intrauterine adhesions was evaluated by third-look hysteroscopy, if the score was greater than 0, a adhesion reformation was considered.

  at 8 weeks post-operation

• The American Fertility Society Score 8 Weeks After Operation

  The American Fertility Society(AFS) score of each group was evaluated again at third-look hysteroscopy in order to reflect the efficacy of the treatment. The original AFS score was recorded in baseline characteristics part. The AFS score ranges from 0-12, while represented the severity of the adhesions. Mild 1-4, Moderate 5-8, Severe 9-12. The lower the AFS score is, the better the prognosis the patient is. When the surgery was finished the AFS score score should be 0.

  at 8 weeks post-operation

• Pictorial Blood Loss Assessment Chart Score 8 Weeks After Operation

  The Pictorial Blood Loss Assessment Chart (PBAC) score was used to represent the menstrual flow volume of the patient. The PBAC score was evaluated again at 8 weeks after surgery. A higher PBAC score after hysteroscopic adhesiolysis means a better outcome.The PBAC score of a normal women usually range from 30-100 points. The minium value of PBAC score is 0, which means the patient is amenorrhea. The maximum value of PBAC score is 1000. We measured the score before and 8 weeks after the operation in order to assess if there was any improvement (higher than before) in menstrual flow.

  at 8 weeks post-operation

Secondary Outcomes (1)

• Pregnancy Outcome Within 12 Months Follow-up After Third Look Hysteroscopy

  within 12 months after third look hysteroscopy(8 weeks post-operation)

Study Arms (2)

IUB dilatation therapy

EXPERIMENTAL

The patient will have Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will be carried out 8 weeks after the surgery.

Procedure: IUB dilatation therapy

control group

NO INTERVENTION

Patient will not undergo any balloon therapy. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will be carried out 8 weeks after the surgery.

Interventions

IUB dilatation therapy PROCEDURE

A Foley catheter (size 14fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-4.5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present.

IUB dilatation therapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women aged 18-40 years;
• moderate to severe intrauterine adhesion (AFS score≥5);
• no previous history of hysteroscopic adhesiolysis in our hospital;
• written consent obtained
• agreement to have second-look and third-look hysteroscopy.

You may not qualify if:

• minimal adhesion (AFS score \<5);
• previous hysteroscopic adhesiolysis in our hospital.

Sponsors & Collaborators

• Fu Xing Hospital, Capital Medical University: lead

Study Sites (1)

Fu Xing Hospital

Beijing, Beijing Municipality, 100038, China

Location

Related Publications (10)

• Saravelos SH, Li TC. Ultrasound-guided treatment of intrauterine adhesions in the outpatient setting. Ultrasound Obstet Gynecol. 2017 Aug;50(2):278-280. doi: 10.1002/uog.16218. No abstract available.

  PMID: 27420903 BACKGROUND

• March CM. Intrauterine adhesions. Obstet Gynecol Clin North Am. 1995 Sep;22(3):491-505.

  PMID: 8524533 BACKGROUND

• ASHERMAN JG. Traumatic intra-uterine adhesions. J Obstet Gynaecol Br Emp. 1950 Dec;57(6):892-6. doi: 10.1111/j.1471-0528.1950.tb06053.x. No abstract available.

  PMID: 14804168 BACKGROUND

• ASHERMAN JG. Amenorrhoea traumatica (atretica). J Obstet Gynaecol Br Emp. 1948 Feb;55(1):23-30. doi: 10.1111/j.1471-0528.1948.tb07045.x. No abstract available.

  PMID: 18902559 BACKGROUND

• Valle RF, Sciarra JJ. Intrauterine adhesions: hysteroscopic diagnosis, classification, treatment, and reproductive outcome. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 1):1459-70. doi: 10.1016/0002-9378(88)90382-1.

  PMID: 3381869 BACKGROUND

• Orhue AA, Aziken ME, Igbefoh JO. A comparison of two adjunctive treatments for intrauterine adhesions following lysis. Int J Gynaecol Obstet. 2003 Jul;82(1):49-56. doi: 10.1016/s0020-7292(03)00030-4.

  PMID: 12834941 BACKGROUND

• Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008 Apr;89(4):759-79. doi: 10.1016/j.fertnstert.2008.02.096.

  PMID: 18406834 BACKGROUND

• Saravelos SH, Jayaprakasan K, Ojha K, Li TC. Assessment of the uterus with three-dimensional ultrasound in women undergoing ART. Hum Reprod Update. 2017 Mar 1;23(2):188-210. doi: 10.1093/humupd/dmw040.

  PMID: 28007752 BACKGROUND

• Grimbizis GF, Di Spiezio Sardo A, Saravelos SH, Gordts S, Exacoustos C, Van Schoubroeck D, Bermejo C, Amso NN, Nargund G, Timmermann D, Athanasiadis A, Brucker S, De Angelis C, Gergolet M, Li TC, Tanos V, Tarlatzis B, Farquharson R, Gianaroli L, Campo R. The Thessaloniki ESHRE/ESGE consensus on diagnosis of female genital anomalies. Gynecol Surg. 2016;13:1-16. doi: 10.1007/s10397-015-0909-1. Epub 2015 Nov 4.

  PMID: 26918000 BACKGROUND

• Shi X, Saravelos SH, Zhou Q, Huang X, Xia E, Li TC. Prevention of postoperative adhesion reformation by intermittent intrauterine balloon therapy: a randomised controlled trial. BJOG. 2019 Sep;126(10):1259-1266. doi: 10.1111/1471-0528.15843. Epub 2019 Jul 18.

  PMID: 31207009 DERIVED

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Dr. Shi Xiaoyu
• Organization: Fuxing Hospital, Capital Medical University, Beijing, China

petershi1990@163.com

+86 18618496384

Study Officials

• Tinchiu Li

  Fuxing Hospital,Capital Medical University，China

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Both surgeons conducting the hysteroscopic surgery and follow-up hysteroscopy were blinded to the patient group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 27, 2017
• Study Start: May 15, 2017
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2018
• Last Updated: September 13, 2019
• Results First Posted: September 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)