PainNCT01307111
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
A study testing Misoprostol in people with Pain, run by University of New Mexico.
Trial summary
The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- 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
- 85 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Mar 2013
- 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 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 14 years old or older
- Negative pregnancy test
- No prior pregnancies lasting beyond 19 6/7 weeks
- Minimum 2 weeks after spontaneous or medical abortion
- Minimum 4 weeks post 2nd trimester or surgical abortion
- No previous IUD insertions
Show all 9Show fewer
- No PID in last 3 months
- No current cervicitis
- Willing to follow-up in 1-2 months for an IUD string check
Who cannot join
- Active cervical infection
- Current pregnancy
- Prior pregnancy beyond 19 6/7 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
About this study
Official title: A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in IUD Insertion for Nulliparous Women
The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.
Read the detailed description
The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD insertion because of the drug's known effect as a cervical ripening agent. Limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of IUD insertion in nulliparous women. The goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and decreases pain.
- Conditions
- Pain
- Being tested
- Misoprostol, Placebo
- Keywords
- Misoprostol, IUD insertion, Nulliparous Women, Contraception, Family Planning, IUD insertion in nulliparous women
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
400 micrograms inserted buccally or vaginally, 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 buccally or vaginally, 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.
Patient Perceived Pain on a 100-point Visual Analogue Scale.
Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge.
Measured: Prior to insertion, immediately after insertion, and prior to clinic discharge.
Secondary outcomes (1)
Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.
Perceived ease of IUD insertion registered on a visual analogue scale (0 = easy, 100 = extremely difficult).
Measured: Immediately post IUD insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2013
- Study completionMar 2013
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 PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eve Espey, University of New Mexico
- Investigators
- Eve Espey, MD/MPH, Principal investigator, University of New Mexico Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307111
- Sponsor's protocol ID
- HRRC #09-426
- Status last verified
- Feb 2016
- First submitted
- 1 Mar 2011
- Last updated
- 28 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in IUD Insertion for Nulliparous Women
- ClinicalTrials.gov ID
- NCT01307111
- Acronym / sponsor ID
- HRRC #09-426
- Conditions
- Pain
- Keywords
- Misoprostol, IUD insertion, Nulliparous Women, Contraception, Family Planning, IUD insertion in nulliparous women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Posted 28 Mar 2016
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 makes the intrauterine device insertion easier and less painful in women who have never had a baby.
Detailed description
The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD insertion because of the drug's known effect as a cervical ripening agent. Limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of IUD insertion in nulliparous women. The goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and decreases pain.
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 buccally or vaginally, 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
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 14 years old or older
- Negative pregnancy test
- No prior pregnancies lasting beyond 19 6/7 weeks
- Minimum 2 weeks after spontaneous or medical abortion
- Minimum 4 weeks post 2nd trimester or surgical abortion
Key exclusion criteria (8 listed)
- Active cervical infection
- Current pregnancy
- Prior pregnancy beyond 19 6/7 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 |
|---|---|---|
| Misoprostol400 micrograms inserted buccally or vaginally, 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
Patient Perceived Pain on a 100-point Visual Analogue Scale.
Time frame: Prior to insertion, immediately after insertion, and prior to clinic discharge.
Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge.
1 secondary outcome
Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.
Time frame: Immediately post IUD insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
- 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.
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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.
Eve Espey, MD/MPH principal investigator
University of New Mexico Department of Obstetrics and Gynecology
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol in people with Pain, run by University of New Mexico.
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 9 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 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 28 Mar 2016). 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?
Patient Perceived Pain on a 100-point Visual Analogue Scale. (time frame: Prior to insertion, immediately after insertion, and prior to clinic discharge.). 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 NCT01307111, 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 28 Mar 2016.