Multi-dose Ibuprofen Prophylaxis for IUD-insertion

Pelvic Pain Clinical Trial

— MIPI  

Official title:

Multi-dose Ibuprofen Prophylaxis for IUD-insertion (MIPI): A Triple Blinded

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03868137
• Other study ID #: 1335793-1
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: May 2022

Study information

• Verified date: October 2020
• Source: Orlando VA Medical Center
• Contact: Chensi Ouyang, MD
• Phone: 407-631-1000
• Email: chensi.ouyang[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• IUD
• Pelvic Pain

Intervention

Drug:
• Ibuprofen
3 doses of Ibuprofen 800 mg
• Placebos
Placebo

Locations

Country	Name	City	State
United States	Orlando VA Medical Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Orlando VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View Citation

Chor J, Bregand-White J, Golobof A, Harwood B, Cowett A. Ibuprofen prophylaxis for levonorgestrel-releasing intrauterine system insertion: a randomized controlled trial. Contraception. 2012 Jun;85(6):558-62. doi: 10.1016/j.contraception.2011.10.015. Epub 2011 Dec 15. — View 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. Epub 2006 Feb 16. — View Citation

Jensen HH, Blaabjerg J, Lyndrup J. [Prophylactic use of prostaglandin synthesis inhibitors in connection with IUD insertion]. Ugeskr Laeger. 1998 Nov 23;160(48):6958-61. Danish. — View Citation

Kavanaugh ML, Jerman J, Finer LB. Changes in Use of Long-Acting Reversible Contraceptive Methods Among U.S. Women, 2009-2012. Obstet Gynecol. 2015 Nov;126(5):917-27. doi: 10.1097/AOG.0000000000001094. — View 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. Review. Update in: Cochrane Da — View 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. — View 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. — View 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. — View 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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain at time of IUD insertion	Pain score measured on 10 point visual analog scale (VAS): 0-3 mild pain, 4-7 moderate pain, 8-10 severe pain	At time of IUD insertion
Secondary	Pain at 1 day after IUD insertion	Pain score measured on 10 point visual analog scale (VAS): 0-3 mild pain, 4-7 moderate pain, 8-10 severe pain	1 day after IUD insertion
Secondary	Usage of other medications or methods to decrease post-IUD insertion pain	Names of other medications or methods	1 day after IUD insertion