ContraceptionmisoNCT01147497
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
A study testing Misoprostol in people with Contraception, run by Emory University at 1 site in United States.
Trial summary
Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. 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
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Sep 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
- negative pregnancy test
- no prior pregnancy beyond 19 6/7 weeks
- no pelvic inflammatory disease in last 3 months
- no current cervicitis
- willing to follow up in 1-2 months
Who cannot join
- active cervical infection
- current pregnancy
- prior pregnancy beyond 19 6/7 weeks
- uterine anomaly
- fibroid uterus distorting uterine cavity
- copper allergy or wilson's disease for ParaGard
Show all 12Show fewer
- undiagnosed abnormal uterine bleeding
- cervical or uterine cancer
- sepsis associated with the most recent pregnancy
- current breast cancer for levonogestrel IUD
- inflammatory bowel disease
- allergy to misoprostol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in Intrauterine Device Insertion for Nulliparous Women
Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.
Read the detailed description
There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization[1], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. 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 give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. The null hypothesis is that misoprostol does not influence difficulty of insertion or patient perception of pain. The primary outcome is the ability to insert the IUD without dilation of the cervix or using ultrasound for guidance.
- 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
400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit
PlaceboDrug
Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit
| Study group | Role | What they receive |
|---|---|---|
| misoprostol | Experimental | Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit Receives: Drug: Misoprostol |
| placebo | Placebo comparator | Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit 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
The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).
Measured: assessed immediately post IUD insertion
Secondary outcomes (6)
Patient Perceived Pain on a 100 Point Visual Analogue Scale
The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).
Measured: immediately after insertion
The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD
Measured: assessed immediately after IUD insertion
Time for Insertion Procedure
Measured: assessed immediately after IUD insertion
Acceptability of Discomfort Associated With Insertion
Measured: assessed at one week after insertion and at one month after insertion
Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women
Measured: assessed immediately following insertion
Need for Additional Pain Medications After Insertion of the IUD
Measured: assessed one week after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2011
- Study completionSep 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 Emory UniversityThe 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Lathrop, MD, Emory University
- Investigators
- Eva Lathrop, MD, MPH, Principal investigator, Emory University School of Medicine, Department of Gynecology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147497
- Sponsor's protocol ID
- IRB00021303
- Other IDs
- MISO Emory
- Acronym
- miso
- Status last verified
- Jan 2018
- First submitted
- 15 Jun 2010
- Last updated
- 12 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lathrop E, Haddad L, McWhorter CP, Goedken P. Self-administration of misoprostol prior to intrauterine device insertion among nulliparous women: a randomized controlled trial. Contraception. 2013 Dec;88(6):725-9. doi: 10.1016/j.contraception.2013.07.011. Epub 2013 Aug 6.
PubMed 24034580Turok 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 12 Jan 2018. 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 Intrauterine Device Insertion for Nulliparous Women
- ClinicalTrials.gov ID
- NCT01147497
- Acronym / sponsor ID
- miso / IRB00021303
- Conditions
- Contraception
- Keywords
- IUD insertion, nulliparous women, contraception, family planning, IUD insertion in nulliparous women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 24 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.
Detailed description
There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization[1], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. 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 give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. The null hypothesis is that misoprostol does not influence difficulty of insertion or patient perception of pain. The primary outcome is the ability to insert the IUD without dilation of the cervix or using ultrasound for guidance.
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 400mcg taken buccally 2 hours prior to IUD insertion visit |
| placebo | Placebo comparator | Drug: PlaceboPill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 years
- negative pregnancy test
- no prior pregnancy beyond 19 6/7 weeks
- no pelvic inflammatory disease in last 3 months
- no current cervicitis
Key exclusion criteria (12 listed)
- active cervical infection
- current pregnancy
- prior pregnancy beyond 19 6/7 weeks
- 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 |
|---|---|---|
| Misoprostol400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit | Drug | misoprostol |
| PlaceboPill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit | Drug | placebo |
Primary outcome
Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale
Time frame: assessed immediately post IUD insertion
The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).
6 secondary outcomes
Patient Perceived Pain on a 100 Point Visual Analogue Scale
Time frame: immediately after insertion
The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD
Time frame: assessed immediately after IUD insertion
Time for Insertion Procedure
Time frame: assessed immediately after IUD insertion
Acceptability of Discomfort Associated With Insertion
Time frame: assessed at one week after insertion and at one month after insertion
Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women
Time frame: assessed immediately following insertion
Need for Additional Pain Medications After Insertion of the IUD
Time frame: assessed one week after insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24034580Lathrop E, Haddad L, McWhorter CP, Goedken P. Self-administration of misoprostol prior to intrauterine device insertion among nulliparous women: a randomized controlled trial. Contraception. 2013 Dec;88(6):725-9. doi: 10.1016/j.contraception.2013.07.011. Epub 2013 Aug 6.
- 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.
Eva Lathrop, MD, MPH principal investigator
Emory University School of Medicine, Department of Gynecology and Obstetrics
1 site 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 Emory University at 1 site 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 12 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 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 24 Mar 2014). 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 (time frame: assessed 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 NCT01147497, 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 12 Jan 2018.