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Multi-dose Ibuprofen Prophylaxis for IUD-insertion (MIPI)

Primary Purpose

Pelvic Pain, IUD

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ibuprofen

Placebos

About this trial

This is an interventional treatment trial for Pelvic Pain focused on measuring NSAID, Intrauterine Devices, Ibuprofen, Pelvic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Orlando VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Ibuprofen

Arm Description

3 doses of placebo identical to study drug will be given to patients starting 1 day before IUD insertion

3 doses of Ibuprofen 800 mg will be given to patients starting 1 day before IUD insertion. Patient will take 800 mg Ibuprofen at noon and 8 PM day before IUD insertion and at 8 AM on the day of IUD insertion.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Usage of other medications or methods to decrease post-IUD insertion pain

Names of other medications or methods

Full Information

NCT ID

NCT03868137

First Posted

March 6, 2019

Last Updated

October 7, 2020

Sponsor

Orlando VA Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03868137

Brief Title

Multi-dose Ibuprofen Prophylaxis for IUD-insertion

Acronym

MIPI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 28, 2020 (Actual)

Primary Completion Date

May 2022 (Anticipated)

Study Completion Date

May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Orlando VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Pain, IUD

Keywords

NSAID, Intrauterine Devices, Ibuprofen, Pelvic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Triple blind randomized control trial involving placebo arm and intervention arm (Ibuprofen)

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

A randomization sequence will be generated and given to the research pharmacist who will dispense the appropriate medications to the participants in each arm. Only the pharmacist will know which patient is in which trial arm until the study has ended and data has been analyzed.

Allocation

Randomized

Enrollment

86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

3 doses of placebo identical to study drug will be given to patients starting 1 day before IUD insertion

Arm Title

Ibuprofen

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Intervention Description

3 doses of Ibuprofen 800 mg

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Pain at time of IUD insertion

Description

Pain score measured on 10 point visual analog scale (VAS): 0-3 mild pain, 4-7 moderate pain, 8-10 severe pain

Time Frame

At time of IUD insertion

Secondary Outcome Measure Information:

Title

Pain at 1 day after IUD insertion

Description

Pain score measured on 10 point visual analog scale (VAS): 0-3 mild pain, 4-7 moderate pain, 8-10 severe pain

Time Frame

1 day after IUD insertion

Title

Usage of other medications or methods to decrease post-IUD insertion pain

Description

Names of other medications or methods

Time Frame

1 day after IUD insertion

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Patient must be female since IUDs are female contraception.

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chensi Ouyang, MD

Phone

407-631-1000

chensi.ouyang@va.gov

Facility Information:

Facility Name

Orlando VA Medical Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32827

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chensi Ouyang, MD

chensi.ouyang@va.gov

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26444110

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):917-927. doi: 10.1097/AOG.0000000000001094.

Results Reference

background

PubMed Identifier

16824298

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.

Results Reference

background

PubMed Identifier

16484309

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.

Results Reference

background

PubMed Identifier

9846090

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.

Results Reference

background

PubMed Identifier

22176793

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.

Results Reference

background

PubMed Identifier

25487172

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.

Results Reference

background

PubMed Identifier

4612152

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.

Results Reference

background

PubMed Identifier

26241253

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.

Results Reference

background

PubMed Identifier

27824753

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.

Results Reference

background

PubMed Identifier

21477680

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.

Results Reference

result

PubMed Identifier

25924648

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.

Results Reference

result

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Multi-dose Ibuprofen Prophylaxis for IUD-insertion

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