ContraceptionNCT01001897
Use of Misoprostol for Intrauterine Device (IUD) Insertion in Nulliparous Women
A study testing Misoprostol in people with Contraception, run by University of Arizona at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate if the use of misoprostol can make it easier for a provider, and less painful for a woman, to place an IUD if she has never had a child before. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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, no prior pregnancy beyond 14 week
- Over 18 years of age
- Negative pregnancy test
Who cannot join
- current pregnancy or pregnancy within 6 weeks
- current cervicitis or PID (active or within 3 months)
- undiagnosed abnormal uterine bleeding
- allergy to copper/ Wilson's disease (for Paragard)
- cervical or uterine cancer
- uterine anomaly altering uterine cavity
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPH-Kino multispecialty clinic
Tucson, Arizona, 85713
University Medical Center Ob/Gyn clinic 8OPC
Tucson, Arizona, 85724
About this study
Official title: A Randomized Control Trial of Misoprostol vs. Placebo for Cervical Preparation in IUD Insertion for Nulliparous Women
The purpose of this study is to evaluate if the use of misoprostol can make it easier for a provider, and less painful for a woman, to place an IUD if she has never had a child before.
Read the detailed description
IUD's are a tremendously effective long acting, reversible method of contraception, and they require little participation from the woman after insertion. Despite these benefits, few women in the US use an IUD. Education is important so that both providers and women understand that IUD's are safe and effective in women even if they have never had a child. Insertion of an IUD in nulliparous patients can be more difficult and uncomfortable. The purpose of this study is to see if use of misoprostol prior to IUD placement in nulliparous women can make it easier and less painful. The goal is that more information on the feasibility and ease of IUD insertion will make it more accessible to more women. The findings from this trial will be used in a prospective meta analysis on this topic.
- Conditions
- Contraception
- Being tested
- Misoprostol, Placebo
- Keywords
- IUD insertion, nulliparous women, contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion
PlaceboDrug
400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion
| Study group | Role | What they receive |
|---|---|---|
| misoprostol | Experimental | 400 micrograms of misoprostol inserted buccally or vaginally prior to IUD insertion Receives: Drug: Misoprostol |
| Placebo | Placebo comparator | Troches identical to experimental drug inserted buccally or vaginally prior to IUD insertion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale
Measured: after IUD insertion
Secondary outcomes (6)
Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia
Measured: during IUD insertion
Side effects of medications
Measured: prior to IUD insertion
Provider perceived ease of insertion on a 100 mm visual analogue scale
Measured: after IUD insertion
Acceptability of wait time prior to IUD placement
Measured: 1 week after IUD insertion
Procedure complications
Measured: Up to 1 month after IUD placement
Acceptability of total IUD placement process, would you recommend this to a friend?
Measured: 1 week and 1 month after IUD insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 ArizonaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pam Lotke, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001897
- Sponsor's protocol ID
- 09004201
- Status last verified
- Jun 2012
- First submitted
- 26 Oct 2009
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Espey E, Singh RH, Leeman L, Ogburn T, Fowler K, Greene H. Misoprostol for intrauterine device insertion in nulliparous women: a randomized controlled trial. Am J Obstet Gynecol. 2014 Mar;210(3):208.e1-5. doi: 10.1016/j.ajog.2013.11.018. Epub 2013 Nov 8.
PubMed 24215850Turok 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 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Misoprostol vs. Placebo for Cervical Preparation in IUD Insertion for Nulliparous Women
- ClinicalTrials.gov ID
- NCT01001897
- Acronym / sponsor ID
- 09004201
- Conditions
- Contraception
- Keywords
- IUD insertion, nulliparous women, contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Not posted in the source record
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 evaluate if the use of misoprostol can make it easier for a provider, and less painful for a woman, to place an IUD if she has never had a child before.
Detailed description
IUD's are a tremendously effective long acting, reversible method of contraception, and they require little participation from the woman after insertion. Despite these benefits, few women in the US use an IUD. Education is important so that both providers and women understand that IUD's are safe and effective in women even if they have never had a child. Insertion of an IUD in nulliparous patients can be more difficult and uncomfortable. The purpose of this study is to see if use of misoprostol prior to IUD placement in nulliparous women can make it easier and less painful. The goal is that more information on the feasibility and ease of IUD insertion will make it more accessible to more women. The findings from this trial will be used in a prospective meta analysis on this topic.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| misoprostol | Experimental | Drug: Misoprostol400 micrograms of misoprostol inserted buccally or vaginally prior to IUD insertion |
| Placebo | Placebo comparator | Drug: PlaceboTroches identical to experimental drug inserted buccally or vaginally prior to IUD insertion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Nulliparous, no prior pregnancy beyond 14 week
- Over 18 years of age
- Negative pregnancy test
Key exclusion criteria (6 listed)
- current pregnancy or pregnancy within 6 weeks
- current cervicitis or PID (active or within 3 months)
- undiagnosed abnormal uterine bleeding
- allergy to copper/ Wilson's disease (for Paragard)
- cervical or uterine cancer
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 |
|---|---|---|
| Misoprostol400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion | Drug | misoprostol |
| Placebo400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion | Drug | Placebo |
Primary outcome
The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale
Time frame: after IUD insertion
6 secondary outcomes
Need to use adjuvant measures for IUD placement, such as dilation, ultrasound guidance, anesthesia
Time frame: during IUD insertion
Side effects of medications
Time frame: prior to IUD insertion
Provider perceived ease of insertion on a 100 mm visual analogue scale
Time frame: after IUD insertion
Acceptability of wait time prior to IUD placement
Time frame: 1 week after IUD insertion
Procedure complications
Time frame: Up to 1 month after IUD placement
Acceptability of total IUD placement process, would you recommend this to a friend?
Time frame: 1 week and 1 month after IUD insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
- Derived from this study: PubMed 24215850Espey E, Singh RH, Leeman L, Ogburn T, Fowler K, Greene H. Misoprostol for intrauterine device insertion in nulliparous women: a randomized controlled trial. Am J Obstet Gynecol. 2014 Mar;210(3):208.e1-5. doi: 10.1016/j.ajog.2013.11.018. Epub 2013 Nov 8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arizona 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 6 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 14 Jun 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale (time frame: after 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 NCT01001897, 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 14 Jun 2012.