ContraceptionNCT00613366
Misoprostol With Intrauterine Device Insertion
A study testing Misoprostol and Magnesium Oxide in people with Contraception, run by Oregon Health and Science University at 2 sites in United States.
Trial summary
The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an intrauterine device for contraception reduces pain in women who have never delivered a baby. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Misoprostol and Magnesium Oxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2007to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous women (defined as those without a history of pregnancy, despite the outcome, beyond 20 weeks gestation)
- Ages 18-45
- Seeking long-term reversible contraception with an intrauterine device (either Mirena or Paraguard) through the OHSU Center for Women's Health and Planned Parenthood of the Columbia Willamette
Who cannot join
- Pregnancy occurring less than 6 weeks from time of presentation
- History of prior intrauterine device placement
- History of Mullerian tract anomalies
- History of uterine surgery
- Allergy or intolerance to misoprostol or other prostaglandin
- Pelvic inflammatory disease (current or within the past 3 months)
Show all 13Show fewer
- Sexually transmitted diseases (current)
- Puerperal or postabortion sepsis (current or within the past 3 months)
- Purulent cervicitis (current)
- Undiagnosed abnormal vaginal bleeding
- Malignancy of the genital tract
- Known uterine anomalies or fibroids distorting the cavity in a way incompatible with intrauterine device insertion
- Allergy to any component of the intrauterine device or Wilson's disease (for copper- containing intrauterine device)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood of the Columbia Willamette
Portland, Oregon, 97206
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Effect of Prophylactic Misoprostol Prior to Intrauterine Device Insertion
The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an intrauterine device for contraception reduces pain in women who have never delivered a baby.
Read the detailed description
The investigators intend to conduct a randomized double blind study at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette.
Subjects will be approached only after deciding to get an intrauterine. When the participants return for intrauterine device placement, at 90 minutes prior to the procedure half will receive misoprostol and half will receive placebo. The subjects will be asked to rate their level of pain at specific points during the insertion. Providers will be asked to mark whether or not additional dilation was required as well as their perceived ease of intrauterine device placement.
- Conditions
- Contraception
- Being tested
- Misoprostol, Magnesium Oxide
- Keywords
- intrauterine device, cervical dilation, nulliparous women, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called prostaglandin
Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
Magnesium OxideDietary supplement
Also called Magnesium, Placebo
Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Experimental | Cervical preparation with misoprostol prior to intrauterine device insertion Receives: Drug: Misoprostol |
| Placebo | Placebo comparator | Cervical preparation with placebo prior to intrauterine device insertion Receives: Dietary Supplement: Magnesium Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).
Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right).
Measured: Time of IUD insertion
Secondary outcomes (1)
Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).
Perceived pain measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right).
Measured: At time of IUD insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJun 2007
- Primary completionApr 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Edelman, Oregon Health and Science University
- Investigators
- Alison Edelman, M.D., M.P.H, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613366
- Sponsor's protocol ID
- OHSU RES 3489
- Status last verified
- Feb 2013
- First submitted
- 29 Jan 2008
- Last updated
- 15 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Turok DK, Espey E, Edelman AB, Lotke PS, Lathrop EH, Teal SB, Jacobson JC, Simonsen SE, Schulz KF. The methodology for developing a prospective meta-analysis in the family planning community. Trials. 2011 Apr 29;12:104. doi: 10.1186/1745-6215-12-104.
PubMed 21527040
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylactic Misoprostol Prior to Intrauterine Device Insertion
- ClinicalTrials.gov ID
- NCT00613366
- Acronym / sponsor ID
- OHSU RES 3489
- Conditions
- Contraception
- Keywords
- intrauterine device, cervical dilation, nulliparous women, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Posted 15 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an intrauterine device for contraception reduces pain in women who have never delivered a baby.
Detailed description
The investigators intend to conduct a randomized double blind study at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette.
Subjects will be approached only after deciding to get an intrauterine. When the participants return for intrauterine device placement, at 90 minutes prior to the procedure half will receive misoprostol and half will receive placebo. The subjects will be asked to rate their level of pain at specific points during the insertion. Providers will be asked to mark whether or not additional dilation was required as well as their perceived ease of intrauterine device placement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Experimental | Drug: MisoprostolCervical preparation with misoprostol prior to intrauterine device insertion |
| Placebo | Placebo comparator | Dietary Supplement: Magnesium OxideCervical preparation with placebo prior to intrauterine device insertion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Nulliparous women (defined as those without a history of pregnancy, despite the outcome, beyond 20 weeks gestation)
- Ages 18-45
- Seeking long-term reversible contraception with an intrauterine device (either Mirena or Paraguard) through the OHSU Center for Women's Health and Planned Parenthood of the Columbia Willamette
Key exclusion criteria (13 listed)
- Pregnancy occurring less than 6 weeks from time of presentation
- History of prior intrauterine device placement
- History of Mullerian tract anomalies
- History of uterine surgery
- Allergy or intolerance to misoprostol or other prostaglandin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolAlso: prostaglandinPlace 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes. | Drug | Misoprostol |
| Magnesium OxideAlso: Magnesium, PlaceboPlace 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes. | Dietary supplement | Placebo |
Primary outcome
The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).
Time frame: Time of IUD insertion
Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right).
1 secondary outcome
Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).
Time frame: At time of IUD insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21527040Turok DK, Espey E, Edelman AB, Lotke PS, Lathrop EH, Teal SB, Jacobson JC, Simonsen SE, Schulz KF. The methodology for developing a prospective meta-analysis in the family planning community. Trials. 2011 Apr 29;12:104. doi: 10.1186/1745-6215-12-104.
- (Women's Health Research Unit website)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Edelman, M.D., M.P.H principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol and Magnesium Oxide in people with Contraception, run by Oregon Health and Science University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS). (time frame: Time of IUD insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00613366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2013.