Trial Outcomes & Findings for Adjuvant Therapy for Intrauterine Adhesions Between Two Groups (NCT NCT02867202)

Last Updated: 2020-01-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

171 participants

Primary outcome timeframe

2 or 3 months after the surgery

Results posted on

2020-01-02

Participant Flow

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)

1. not meeting inclusion criteria 2. declined to participate

Participant milestones

Participant milestones
Measure	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. And hysteroscopy was taken out again after two or three menstrual cycles to evaluate the uterine adhesions.	Intrauterine Contraceptive Device Plus Foley Catheter 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.
Overall Study STARTED	83	88
Overall Study COMPLETED	62	56
Overall Study NOT COMPLETED	21	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adjuvant Therapy for Intrauterine Adhesions Between Two Groups

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intrauterine Balloon n=62 Participants 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.	IUD Plus Foley Catheter n=56 Participants 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 n=118 Participants Total of all reporting groups
Age, Continuous	31.69 year STANDARD_DEVIATION 5.268 • n=5 Participants	32.63 year STANDARD_DEVIATION 6.125 • n=7 Participants	32.14 year STANDARD_DEVIATION 5.685 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	56 Participants n=7 Participants	118 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	62 Participants n=5 Participants	56 Participants n=7 Participants	118 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	62 participants n=5 Participants	56 participants n=7 Participants	118 participants n=5 Participants
Parity	0.484 Births STANDARD_DEVIATION 0.565 • n=5 Participants	0.554 Births STANDARD_DEVIATION 0.536 • n=7 Participants	0.517 Births STANDARD_DEVIATION 0.551 • n=5 Participants

PRIMARY outcome

Timeframe: 2 or 3 months after the surgery

Outcome measures

Outcome measures
Measure	Intrauterine Balloon n=62 Participants 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 Device Plus Foley Catheter n=56 Participants 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.
the AFS Score at Second-look Hysteroscopy	6.5 Units on a scale Interval 1.0 to 10.0	8 Units on a scale Interval 3.0 to 12.0

Adverse Events

Intrauterine Balloon

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

IUD Plus Foley Catheter

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intrauterine Balloon n=83 participants at risk 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.	IUD Plus Foley Catheter n=88 participants at risk 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.
Injury, poisoning and procedural complications suffered from moderate to severe postoperative pain	14.5% 12/83 • Number of events 12 • 6 months to 1 year 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.	3.4% 3/88 • Number of events 3 • 6 months to 1 year 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.
Investigations refuse to have second-look hysteroscopy	10.8% 9/83 • Number of events 9 • 6 months to 1 year 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.	23.9% 21/88 • Number of events 21 • 6 months to 1 year 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.
Investigations Protocol violation	3.6% 3/83 • Number of events 3 • 6 months to 1 year 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.	2.3% 2/88 • Number of events 2 • 6 months to 1 year 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.
Investigations Declined to participate	4.8% 4/83 • Number of events 4 • 6 months to 1 year 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.	4.5% 4/88 • Number of events 4 • 6 months to 1 year 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.
Investigations Not meeting inclusion criteria	6.0% 5/83 • Number of events 5 • 6 months to 1 year 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.	5.7% 5/88 • Number of events 5 • 6 months to 1 year 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.

Additional Information

the 1st affiliated hospital of Wenzhou Medical University.

Phone: 0886-0577-88069525

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place