ContraceptionMPIINNCT00886834
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
A study testing Misoprostol in people with Contraception, run by University of Utah at 2 sites in United States.
Trial summary
The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to Mar 2011
- 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
- 18 years old or older
- negative pregnancy test
- no prior pregnancies beyond 14 6/7 weeks
- no PID in last 3 months
- no current cervicitis
- be willing to follow-up in 1-2 months for an IUD string check.
Who cannot join
- active cervical infection
- current pregnancy
- prior pregnancy beyond 14 weeks gestation
- known uterine anomaly
- fibroid uterus distorting uterine cavity
- copper allergy/Wilson's disease (for Paragard)
- undiagnosed abnormal uterine bleeding
- cervical or uterine cancer.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood Association of Utah
Salt Lake City, Utah, 84111
University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: A Randomized Control Trial of Misoprostol vs. Placebo Prior to IUD Insertion in Nulliparous Women
The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.
Read the detailed description
Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers use this drug to facilitate insertion. While there is a wealth of data on the use of misoprostol prior to many procedures requiring cervical dilation there is minimal objective evidence assessing its effect on provider ease of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of this trial will be contributed to a prospective meta-analysis on the subject.
- Conditions
- Contraception
- Being tested
- Misoprostol, Placebo
- Keywords
- IUD insertion, Nulliparous women, Contraception, Family Planning, IUD insertion in nulliparous women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
400 micrograms inserted vaginally or buccally, per the participants desire prior to the IUD insertion.
PlaceboDrug
Pills which are identical to the study drug in appearance, taste, and smell.
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Experimental | Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire. Receives: Drug: Misoprostol |
| Placebo | Placebo comparator | Pills which are identical to the study drug in appearance, taste, and smell. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)
VAS (anchors: 0 = extremely easy, 100 mm= impossible)
Measured: Immediately post IUD insertion
Secondary outcomes (1)
Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)
VAS; anchors: 0 =none, 100 mm= worst imaginable
Measured: prior to insertion, immediately after insertion, and prior to clinic discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2011
- Study completionMar 2011
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 (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Turok, University of Utah
- Investigators
- David Turok, MD/MPH, Principal investigator, University of Utah Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886834
- Sponsor's protocol ID
- 24403
- Acronym
- MPIIN
- Status last verified
- Dec 2014
- First submitted
- 22 Apr 2009
- Last updated
- 22 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Swenson C, Turok DK, Ward K, Jacobson JC, Dermish A. Self-administered misoprostol or placebo before intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2012 Aug;120(2 Pt 1):341-7. doi: 10.1097/AOG.0b013e31825d9ec9.
PubMed 22825094Turok 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 22 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Misoprostol vs. Placebo Prior to IUD Insertion in Nulliparous Women
- ClinicalTrials.gov ID
- NCT00886834
- Acronym / sponsor ID
- MPIIN / 24403
- Conditions
- Contraception
- Keywords
- IUD insertion, Nulliparous women, Contraception, Family Planning, IUD insertion in nulliparous women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Posted 22 Dec 2011
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 inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.
Detailed description
Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers use this drug to facilitate insertion. While there is a wealth of data on the use of misoprostol prior to many procedures requiring cervical dilation there is minimal objective evidence assessing its effect on provider ease of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of this trial will be contributed to a prospective meta-analysis on the subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Experimental | Drug: MisoprostolMisoprostol 400 micrograms inserted vaginally or buccally, per the participants desire. |
| Placebo | Placebo comparator | Drug: PlaceboPills which are identical to the study drug in appearance, taste, and smell. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 years old or older
- negative pregnancy test
- no prior pregnancies beyond 14 6/7 weeks
- no PID in last 3 months
- no current cervicitis
Key exclusion criteria (8 listed)
- active cervical infection
- current pregnancy
- prior pregnancy beyond 14 weeks gestation
- known uterine anomaly
- fibroid uterus distorting uterine cavity
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: Cytotec400 micrograms inserted vaginally or buccally, per the participants desire prior to the IUD insertion. | Drug | Misoprostol |
| PlaceboPills which are identical to the study drug in appearance, taste, and smell. | Drug | Placebo |
Primary outcome
Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)
Time frame: Immediately post IUD insertion
VAS (anchors: 0 = extremely easy, 100 mm= impossible)
1 secondary outcome
Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)
Time frame: prior to insertion, immediately after insertion, and prior to clinic discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22825094Swenson C, Turok DK, Ward K, Jacobson JC, Dermish A. Self-administered misoprostol or placebo before intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2012 Aug;120(2 Pt 1):341-7. doi: 10.1097/AOG.0b013e31825d9ec9.
- 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.
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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.
David Turok, MD/MPH principal investigator
University of Utah Department of Obstetrics and Gynecology
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 in people with Contraception, run by University of Utah 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 6 inclusion and 8 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 22 Dec 2014. 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 22 Dec 2011). 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?
Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS) (time frame: Immediately post 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 NCT00886834, which also lists 2 linked publications.
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 22 Dec 2014.