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

October 7, 2020 updated by: Chensi Ouyang, Orlando VA Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
3 doses of placebo identical to study drug will be given to patients starting 1 day before IUD insertion
Drug: Placebos
Placebo
EXPERIMENTAL: Ibuprofen
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.
Drug: Ibuprofen
3 doses of Ibuprofen 800 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain at time of IUD insertion
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain at 1 day after IUD insertion
Time Frame: 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
Usage of other medications or methods to decrease post-IUD insertion pain
Time Frame: 1 day after IUD insertion
Names of other medications or methods
1 day after IUD insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orlando VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 28, 2020

Primary Completion (ANTICIPATED)

May 1, 2022

Study Completion (ANTICIPATED)

May 1, 2022

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (ACTUAL)

March 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1335793-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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