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Pain Control In First Trimester Medical Abortion: A Randomized Trial

PAIN CONTROL IN FIRST TRIMESTER MEDICAL ABORTION: A Randomized Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01457521
Enrollment
250
Registered
2011-10-24
Start date
2011-10-31
Completion date
2012-12-31
Last updated
2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

pain, medical abortion

Brief summary

This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain.

Detailed description

This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain. Secondary objectives include comparing the regimens for the total amount of ibuprofen taken, use of other analgesics, vaginal bleeding, adverse events, successful completion of abortion, overall satisfaction with the abortion procedure.

Interventions

DRUGIbuprofen

Ibuprofen

Sponsors

Society of Family Planning
CollaboratorOTHER
Family Planning Associates Medical Group, LTD
CollaboratorOTHER
Planned Parenthood of Greater New York
CollaboratorOTHER
Gynuity Health Projects
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Pregnant women with a gestational age of 63 days or less * Desire a medical abortion with mifepristone and misoprostol

Exclusion criteria

\- Have contraindications to ibuprofen

Design outcomes

Primary

MeasureTime frameDescription
11-point Visual Analog Scale for Pain1-2 weeksParticipant pain was assessed using an 11-point Visual Analog Scale for Pain. Scores ranged from 0 (no pain) to 10 (worst pain possible)

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
111
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.
117
Total228

Baseline characteristics

CharacteristicProphylacticTherapeuticTotal
Age, Categorical
<=18 years
2 Participants2 Participants4 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
109 Participants115 Participants224 Participants
Sex: Female, Male
Female
111 Participants117 Participants228 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1230 / 127
serious
Total, serious adverse events
0 / 1230 / 127

Outcome results

Primary

11-point Visual Analog Scale for Pain

Participant pain was assessed using an 11-point Visual Analog Scale for Pain. Scores ranged from 0 (no pain) to 10 (worst pain possible)

Time frame: 1-2 weeks

ArmMeasureValue (MEAN)Dispersion
Prophylactic11-point Visual Analog Scale for Pain7.1 units on a scaleStandard Deviation 2.5
Therapeutic11-point Visual Analog Scale for Pain7.3 units on a scaleStandard Deviation 2.2

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026