Trial Outcomes & Findings for A RCT of Ultrasound Guided IUD Insertion (NCT NCT03493815)
NCT ID: NCT03493815
Last Updated: 2020-05-21
Results Overview
IUD discontinuation rates during the 6-month post-insertion period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
6 Months
Results posted on
2020-05-21
Participant Flow
Participant milestones
| Measure |
Transabdominal Ultrasound Guided IUD Insertion
Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
Traditional Blind IUD Insertion
Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
43
|
|
Overall Study
COMPLETED
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A RCT of Ultrasound Guided IUD Insertion
Baseline characteristics by cohort
| Measure |
Transabdominal Ultrasound Guided IUD Insertion
n=40 Participants
Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
Traditional Blind IUD Insertion
n=41 Participants
Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
31.5 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
31.1 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White vs. non-white · White
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White vs. non-white · Non-white
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: Participants who had an IUD inserted and either discontinued the IUD or continued the IUD until the 6m visit were included. Participants who were lost to followup (outcome unknown) were excluded.
IUD discontinuation rates during the 6-month post-insertion period
Outcome measures
| Measure |
Transabdominal Ultrasound Guided IUD Insertion
n=33 Participants
Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
Traditional Blind IUD Insertion
n=32 Participants
Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
|---|---|---|
|
Number of Participants Who Had IUD Removed Within 6 Months
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 4-6 Weeks Post Insertion String CheckPopulation: This analysis includes participants active in the study at the 4-6 week visit. Study participants who discontinued their IUD prior to this visit, or who were lost to followup prior to this visit, were excluded.
String check in the form of a speculum exam in addition to a transvaginal ultrasound to confirm positioning of the IUD
Outcome measures
| Measure |
Transabdominal Ultrasound Guided IUD Insertion
n=32 Participants
Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
Traditional Blind IUD Insertion
n=37 Participants
Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
|---|---|---|
|
Number of Participants With Malpositioned IUD at 4-6 Week Visit
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: pre and post-insertion (both collected during the insertion visit)Population: All participants for whom IUD was inserted.
Pain was assessed pre and post-insertion with a visual analog scale (VAS) ranging from 0-10 with 0 being no pain and 10 being the worst. Change in pain score was calculated as post minus pre, hence the higher the number, the greater increase in pain.
Outcome measures
| Measure |
Transabdominal Ultrasound Guided IUD Insertion
n=40 Participants
Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
Traditional Blind IUD Insertion
n=41 Participants
Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
|---|---|---|
|
Change in Pain Score
|
2.3 units on a scale
Standard Deviation 2.5
|
2.1 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Participants who completed the 6m followup visit.
Satisfaction with IUD was initially assessed using a 5-point likert scale where 1=not at all happy and 5=very happy. The likert scale was then collapsed to a binary outcome of satisfied (likert scale scores 4 and 5) vs. not satisfied (likert scale scores 1,2,3).
Outcome measures
| Measure |
Transabdominal Ultrasound Guided IUD Insertion
n=27 Participants
Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
Traditional Blind IUD Insertion
n=25 Participants
Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
|---|---|---|
|
Number of Participants Satisfied With IUD at 6 Months
|
24 Participants
|
21 Participants
|
Adverse Events
Transabdominal Ultrasound Guided IUD Insertion
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Traditional Blind IUD Insertion
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Transabdominal Ultrasound Guided IUD Insertion
n=40 participants at risk
Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
Traditional Blind IUD Insertion
n=41 participants at risk
Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
|---|---|---|
|
Reproductive system and breast disorders
malpositioned IUD
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
0.00%
0/41 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
Other adverse events
| Measure |
Transabdominal Ultrasound Guided IUD Insertion
n=40 participants at risk
Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
Traditional Blind IUD Insertion
n=41 participants at risk
Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
|---|---|---|
|
Reproductive system and breast disorders
Vaginal bleeding
|
37.5%
15/40 • Number of events 16 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
39.0%
16/41 • Number of events 16 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
12.5%
5/40 • Number of events 5 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
19.5%
8/41 • Number of events 8 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
|
Reproductive system and breast disorders
Heavy or prolonged menses
|
0.00%
0/40 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
4.9%
2/41 • Number of events 2 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
|
Reproductive system and breast disorders
Hormonal side effects
|
0.00%
0/40 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
7.3%
3/41 • Number of events 3 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
0.00%
0/41 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
|
Reproductive system and breast disorders
Bloating
|
0.00%
0/40 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
1/40 • Number of events 1 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
0.00%
0/41 • Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
|
Additional Information
Stephanie Estes, M.D.
The Pennsylvania State Univ College of Medicine, The Milton S. Hershey Medical Center
Phone: 717-531-8478
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place