Trial Outcomes & Findings for Pain Control In First Trimester Medical Abortion: A Randomized Trial (NCT NCT01457521)
NCT ID: NCT01457521
Last Updated: 2016-01-13
Results Overview
Participant pain was assessed using an 11-point Visual Analog Scale for Pain. Scores ranged from 0 (no pain) to 10 (worst pain possible)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
250 participants
Primary outcome timeframe
1-2 weeks
Results posted on
2016-01-13
Participant Flow
Participant milestones
| Measure |
Prophylactic
Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
|
Therapeutic
Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
127
|
|
Overall Study
COMPLETED
|
111
|
117
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pain Control In First Trimester Medical Abortion: A Randomized Trial
Baseline characteristics by cohort
| Measure |
Prophylactic
n=111 Participants
Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
|
Therapeutic
n=117 Participants
Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
109 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-2 weeksParticipant pain was assessed using an 11-point Visual Analog Scale for Pain. Scores ranged from 0 (no pain) to 10 (worst pain possible)
Outcome measures
| Measure |
Prophylactic
n=111 Participants
Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
|
Therapeutic
n=117 Participants
Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
|
|---|---|---|
|
11-point Visual Analog Scale for Pain
|
7.1 units on a scale
Standard Deviation 2.5
|
7.3 units on a scale
Standard Deviation 2.2
|
Adverse Events
Prophylactic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Therapeutic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place