NCT03171454

Brief Summary

In this prospective, randomized, controlled study, the investigators wish to compare the efficacy of immediate and delayed intrauterine balloon (IUB) therapy in the prevention of adhesion reformation after hysteroscopic adhesiolysis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

May 30, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

May 25, 2017

Last Update Submit

June 6, 2017

Conditions

Intrauterine Adhesion

Keywords

hysteroscopic operationintrauterine balloonadhesions

Outcome Measures

Primary Outcomes (1)

  • AFS score

    The degree of intrauterine adhesions described by AFS score reduction at second look hysteroscopy

    at 6 weeks post-op

Secondary Outcomes (2)

  • The menstrual pattern

    at 6 weeks post-op

  • infection rate

    at 6 weeks post-op

Study Arms (2)

Delayed Intrauterine Balloon therapy

EXPERIMENTAL

In the delayed balloon group,a Foley catheter will be inserted into the uterine cavity 2 weeks after the surgery, the balloon will be inflated with normal saline (from 3ml to 5ml) then deflated, and the procedure repeated three time over 3 minutes or so, then the cavity will be flushed with 10 mls of normal saline solution after via the irrigating channel of the Foley catheter before removal. The whole procedure will be repeated a further 2 weeks later.

Procedure: Delayed Intrauterine Balloon therapy

immediate Intrauterine Balloon therapy

EXPERIMENTAL

At the conclusion of the surgery, in the immediate balloon group: a Foley-catheter will be immediately inserted into the uterine cavity and the balloon will be distended with 5mls of saline under ultrasound guidance and the balloon will stay in situ for 7 days.

Procedure: immediate Intrauterine Balloon therapy

Interventions

Delayed Intrauterine Balloon therapyPROCEDURE

D-IUB dilatation therapy group will be performed using a (size 12-14fr) Foley catheter and according to the methodology published in the literature. This will be prepared by cutting the catheter tip protruding beyond the balloon. Once the catheter has reached the fundus, 5mls of saline will be slowly instilled into the balloon under ultrasound guidance.

Delayed Intrauterine Balloon therapy
immediate Intrauterine Balloon therapyPROCEDURE

At the conclusion of the surgery, in the immediate balloon group: a Foley-catheter will be immediately inserted into the uterine cavity and the balloon will be distended with 4-5mls of saline under ultrasound guidance and the balloon will stay in situ for 7 days.

immediate Intrauterine Balloon therapy

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women aged 18-40 years;
  • moderate to severe intrauterine adhesion (AFS score≥5);
  • first episode of hysteroscopicadhesiolysis in our hospital;
  • written consent obtained;
  • agreement to have second-look hysteroscopy.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Xing Hospital

Beijing, Beijing Municipality, 100038, China

RECRUITING

Related Publications (11)

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

    PMID: 8524533BACKGROUND

  • 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: 27420903RESULT

  • Saravelos SH and Li TC. Intrauterine balloon therapy: a novel ultrasound guided treatment for intrauterine adhesions. Gynecological Surgery [Epub ahead of print]

    RESULT

  • 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: 28007752RESULT

  • 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: 12834941RESULT

  • Taskin O, Sadik S, Onoglu A, Gokdeniz R, Erturan E, Burak F, Wheeler JM. Role of endometrial suppression on the frequency of intrauterine adhesions after resectoscopic surgery. J Am Assoc Gynecol Laparosc. 2000 Aug;7(3):351-4. doi: 10.1016/s1074-3804(05)60478-1.

    PMID: 10924629RESULT

  • Healy MW, Schexnayder B, Connell MT, Terry N, DeCherney AH, Csokmay JM, Yauger BJ, Hill MJ. Intrauterine adhesion prevention after hysteroscopy: a systematic review and meta-analysis. Am J Obstet Gynecol. 2016 Sep;215(3):267-275.e7. doi: 10.1016/j.ajog.2016.05.001. Epub 2016 May 10.

    PMID: 27173082RESULT

  • Guida M, Acunzo G, Di Spiezio Sardo A, Bifulco G, Piccoli R, Pellicano M, Cerrota G, Cirillo D, Nappi C. Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Hum Reprod. 2004 Jun;19(6):1461-4. doi: 10.1093/humrep/deh238. Epub 2004 Apr 22.

    PMID: 15105384RESULT

  • Roge P, D'Ercole C, Cravello L, Boubli L, Blanc B. Hysteroscopic management of uterine synechiae: a series of 102 observations. Eur J Obstet Gynecol Reprod Biol. 1996 Apr;65(2):189-93. doi: 10.1016/0301-2115(95)02342-9.

    PMID: 8730623RESULT

  • Schenker JG. Etiology of and therapeutic approach to synechia uteri. Eur J Obstet Gynecol Reprod Biol. 1996 Mar;65(1):109-13. doi: 10.1016/0028-2243(95)02315-j.

    PMID: 8706941RESULT

  • Pabuccu R, Atay V, Orhon E, Urman B, Ergun A. Hysteroscopic treatment of intrauterine adhesions is safe and effective in the restoration of normal menstruation and fertility. Fertil Steril. 1997 Dec;68(6):1141-3. doi: 10.1016/s0015-0282(97)00375-0.

    PMID: 9418714RESULT

MeSH Terms

Conditions

GynatresiaTissue Adhesions

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tinchiu Li

    Fu Xing Hospital, Capital Medical University

    STUDY CHAIR

Central Study Contacts

Lei Guo

CONTACT

+86 15810635320guolei.yale@163.com

Tinchiu Li

CONTACT

+86 010 88062944tinchiu.li@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 31, 2017

Study Start

May 30, 2017

Primary Completion

September 30, 2018

Study Completion

December 31, 2018

Last Updated

June 7, 2017

Record last verified: 2017-06

Locations

CN(1)