Clinical trial NCT03868137: Multi-dose Ibuprofen Prophylaxis for IUD-insertion
Official title: Multi-dose Ibuprofen Prophylaxis for IUD-insertion (MIPI): A Triple Blinded
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Pain
IUD
Keywords: NSAID
Intrauterine Devices
Ibuprofen
Pelvic pain
Lead sponsor: Orlando VA Medical Center
Sponsor class: FED
First posted: 2019-03-08
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Triple blind randomized control trial involving placebo arm and intervention arm (Ibuprofen)
Primary purpose: TREATMENT

Brief summary: This study compares the effectiveness of decreasing pain at time of and day after intrauterine device (IUD) insertion when patients take three doses of Ibuprofen versus three doses of placebo.

Detailed description: Ibuprofen is commonly used over the counter and prescribed for pain relief such as menstrual cramps. Intrauterine (IUD) insertion can cause pain during and after the insertion. Currently, studies have found that single dose of Ibuprofen take prior to IUD insertion does decrease pain at time of IUD insertion. This study will examine whether 3 doses of Ibuprofen can decrease pain at time of and 1 day after IUD insertion.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Female
* Able to provide informed consent
* English speaking
* Able to provide telephone and address contact information
* Able and willing to receive HIPAA compliant telephone texts and phone messages
* Stable (the same) address and phone number within the last 6 months.

Exclusion Criteria:

* Contraindications to IUD insertion (active pelvic infection, current pregnancy)
* Contraindications to NSAIDs (allergy, history of asthma, history of aspirin allergy, history of kidney disease, history of stomach ulcer, history of active GI bleeding, history of liver disease)
* Not undergoing any other concurrent office procedures

Primary outcomes:
measure: Pain at time of IUD insertion
timeFrame: At time of IUD insertion
Secondary outcomes:
measure: Pain at 1 day after IUD insertion
timeFrame: 1 day after IUD insertion
measure: Usage of other medications or methods to decrease post-IUD insertion pain
timeFrame: 1 day after IUD insertion
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando VA Medical Center
state: Florida
Study officials:
References:
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citation: Asker C, Stokes-Lampard H, Beavan J, Wilson S. What is it about intrauterine devices that women find unacceptable? Factors that make women non-users: a qualitative study. J Fam Plann Reprod Health Care. 2006 Apr;32(2):89-94. doi: 10.1783/147118906776276170.
citation: Hubacher D, Reyes V, Lillo S, Pierre-Louis B, Zepeda A, Chen PL, Croxatto H. Preventing copper intrauterine device removals due to side effects among first-time users: randomized trial to study the effect of prophylactic ibuprofen. Hum Reprod. 2006 Jun;21(6):1467-72. doi: 10.1093/humrep/del029. Epub 2006 Feb 16.
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citation: Bednarek PH, Creinin MD, Reeves MF, Cwiak C, Espey E, Jensen JT; Post-Aspiration IUD Randomization (PAIR) Study Trial Group. Prophylactic ibuprofen does not improve pain with IUD insertion: a randomized trial. Contraception. 2015 Mar;91(3):193-7. doi: 10.1016/j.contraception.2014.11.012. Epub 2014 Nov 25.
citation: Massey SE, Varady JC, Henzl MR. Pain relief with naproxen following insertion of an intrauterine device. J Reprod Med. 1974 Dec;13(6):226-31. No abstract available.
citation: Ngo LL, Ward KK, Mody SK. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):29-36. doi: 10.1097/AOG.0000000000000912.
citation: Ngo LL, Braaten KP, Eichen E, Fortin J, Maurer R, Goldberg AB. Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1306-1313. doi: 10.1097/AOG.0000000000001746.
citation: Trussell J. Contraceptive failure in the United States. Contraception. 2011 May;83(5):397-404. doi: 10.1016/j.contraception.2011.01.021. Epub 2011 Mar 12.
citation: Lethaby A, Hussain M, Rishworth JR, Rees MC. Progesterone or progestogen-releasing intrauterine systems for heavy menstrual bleeding. Cochrane Database Syst Rev. 2015 Apr 30;(4):CD002126. doi: 10.1002/14651858.CD002126.pub3.