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Adjuvant Therapy for Intrauterine Adhesions Between Two Groups

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ClinicalTrials.gov Identifier: NCT02867202
Recruitment Status : Completed
First Posted : August 15, 2016
Results First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Feng Lin, Wenzhou Medical University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asherman Syndrome
Interventions Device: Intrauterine balloon
Device: Intrauterine Contraceptive Device Plus Foley Catheter
Enrollment 171
Recruitment Details

all patients were recruited from 1st affiliated hospital of Wenzhou Medical University.

Inclusion criteria were as follows:1) women aged 18 to 45 years. 2) agreed to have second-look hysteroscopy. 3) moderate to severe intrauterine adhesion (AFS score ≥5)

Pre-assignment Details
  1. not meeting inclusion criteria
  2. declined to participate
Arm/Group Title Intrauterine Balloon Intrauterine Contraceptive Device Plus Foley Catheter
Hide Arm/Group Description After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week. And hysteroscopy was taken out again after two or three menstrual cycles to evaluate the uterine adhesions. Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy.
Period Title: Overall Study
Started 83 88
Completed 62 56
Not Completed 21 32
Arm/Group Title Intrauterine Balloon IUD Plus Foley Catheter Total
Hide Arm/Group Description After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.And hysteroscopy was taken out again after two menstrual cycles to evaluate the uterine adhesions. Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy. Total of all reporting groups
Overall Number of Baseline Participants 62 56 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 62 participants 56 participants 118 participants
31.69  (5.268) 32.63  (6.125) 32.14  (5.685)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 56 participants 118 participants
Female
62
 100.0%
56
 100.0%
118
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 56 participants 118 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
62
 100.0%
56
 100.0%
118
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 62 participants 56 participants 118 participants
62 56 118
Parity  
Mean (Standard Deviation)
Unit of measure:  Births
Number Analyzed 62 participants 56 participants 118 participants
0.484  (0.565) 0.554  (0.536) 0.517  (0.551)
1.Primary Outcome
Title the AFS Score at Second-look Hysteroscopy
Hide Description 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.
Time Frame 2 or 3 months after the surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intrauterine Balloon Intrauterine Device Plus Foley Catheter
Hide Arm/Group Description:

The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus,and removed on the 7th day after surgery. And hysteroscopy was taken out again after two menstrual cycles to evaluate the uterine adhesions.

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

Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while Intrauterine Device is removed at the second hysteroscopy. Uterine adhesions are judged again at the second hysteroscopy.

Intrauterine Contraceptive Device Plus Foley Catheter: 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.

Overall Number of Participants Analyzed 62 56
Median (Full Range)
Unit of Measure: Units on a scale
6.5
(1 to 10)
8
(3 to 12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intrauterine Balloon, Intrauterine Device Plus Foley Catheter
Comments Data analysis was performed with SPSS version 22.0, using two-sided test, and a p value < 0.05 was considered statistically significant.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 6 months to 1 year
Adverse Event Reporting Description Among 171 participants who were initially recruited, 18 were excluded from analysis; 8 patients declined to participate and 10 patients did not meet the inclusion criteria. 30 participants subsequently refused to undergo the second-look hysteroscopy, and 5 subjects were also excluded for protocol violation. 17 women in the study reported side effects. 15 subjects suffered from moderate to severe postoperative pain; 12in the COOK balloon stent group and 3 in the IUD plus Foley catheter group.
 
Arm/Group Title Intrauterine Balloon IUD Plus Foley Catheter
Hide Arm/Group Description After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week. And hysteroscopy was taken out again after two or three menstrual cycles to evaluate the uterine adhesions. Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy.
All-Cause Mortality
Intrauterine Balloon IUD Plus Foley Catheter
Affected / at Risk (%) Affected / at Risk (%)
Total   0/83 (0.00%)      0/88 (0.00%)    
Hide Serious Adverse Events
Intrauterine Balloon IUD Plus Foley Catheter
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/83 (0.00%)      0/88 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.3%
Intrauterine Balloon IUD Plus Foley Catheter
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/83 (25.30%)      32/88 (36.36%)    
Injury, poisoning and procedural complications     
suffered from moderate to severe postoperative pain  1  12/83 (14.46%)  12 3/88 (3.41%)  3
Investigations     
refuse to have second-look hysteroscopy  1 [1]  9/83 (10.84%)  9 21/88 (23.86%)  21
Protocol violation  1 [1]  3/83 (3.61%)  3 2/88 (2.27%)  2
Declined to participate  1 [1]  4/83 (4.82%)  4 4/88 (4.55%)  4
Not meeting inclusion criteria  1 [1]  5/83 (6.02%)  5 5/88 (5.68%)  5
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
[1]
excluded
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: the 1st affiliated hospital of Wenzhou Medical University.
Organization: the 1st affiliated hospital of Wenzhou Medical University.
Phone: 0886-0577-88069525
EMail: zfy983023@hotmail.com
Layout table for additonal information
Responsible Party: Feng Lin, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT02867202    
Other Study ID Numbers: Wenzhou MC
First Submitted: April 11, 2016
First Posted: August 15, 2016
Results First Submitted: December 27, 2017
Results First Posted: January 2, 2020
Last Update Posted: January 2, 2020