Pain Control In First Trimester Medical Abortion: A Randomized Trial

Gynuity Health Projects

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT01457521

1000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Therapeutic

Active Comparator group

Description:

Ibuprofen

Treatment:

Drug: Ibuprofen

Prophylactic

Active Comparator group

Description:

Ibuprofen

Treatment:

Drug: Ibuprofen