Family PlanningPhase 3NCT03490617
Misoprostol Prior to IUD Insertion in Nullipara
A Phase 3 study testing Vaginal misoprostol in people with Family Planning, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial summary
The use of misoprostol at a dose of 400 µg administered vaginally four hours prior to IUD insertion increased the ease of insertion and reduced the incidence of pain during the procedure, although the frequency of cramps increased following misoprostol use. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Family Planning
- What is being tested?
- Vaginal misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2009to Nov 2011
- Phase
- Phase 3
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nulliparous women
- No chirurgical procedure in the cervix
- Wish to use IUD as a contraceptive method
Who cannot join
- Presence of active cervical infection visible upon speculum exam (purulent cervicits)
- Pelvic Inflammatory Disease (PID) or other uterine infection diagnosed within the last 3 months (based on self-report or clinical documentation)
- Pregnancy ending less than 6 weeks prior to enrollment in study
- History of prior IUD placement
- History of uterine cavity abnormality including Mullerian tract anomalies and leiomyomas distorting uterine cavity shape
- History of uterine surgery
Show all 11Show fewer
- Allergy or intolerance to misoprostol or other prostaglandin
- Undiagnosed abnormal vaginal bleeding
- Malignancy of the genital tract
- Allergy to any component of the IUD or Wilson's disease (for copper- containing IUDs)
- Pre-procedure use of anesthesia or analgesia (including use of narcotics, benzodiazepines, or use of anesthetic beyond use at the tenaculum site)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, 50070450
About this study
Official title: Misoprostol Prior To Cupper Intra Uternine Device Insertion In Nullipara: A Randomized Clinical Trial
The use of misoprostol at a dose of 400 µg administered vaginally four hours prior to IUD insertion increased the ease of insertion and reduced the incidence of pain during the procedure, although the frequency of cramps increased following misoprostol use.
Read the detailed description
Nulligravidas women of reproductive age were submitted to IUD insertion between July 2009 and November 2011 at the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, Brazil. A total of 179 women were randomly allocated to two groups: 86 to use 400 µg of misoprostol vaginally four hours prior to IUD insertion and 93 to use placebo. Risk ratios (RR) were calculated as measures of relative risk, together with their 95% confidence intervals (95%CI). The number needed to treat (NNT) and the number needed to harm (NNH) were also calculated.
- Conditions
- Family Planning
- Being tested
- Vaginal misoprostol
- Keywords
- Intrauterine device, Misoprostol, Nulliparous women, Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal misoprostolDrug
Also called Prostokos
To determine effectiveness of vaginal misoprostol to facilitate IUD insertion in nulligravida women
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Misoprostol Group | Active comparator | Vaginal misoprostol (400 μg) 4 hours prior to IUD insertion Receives: Drug: Vaginal misoprostol |
| Placebo group | Placebo comparator | Vaginal placebo tablets 4 hours prior to IUD insertion Receives: Drug: Vaginal misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical dilatation
the frequency of women with cervical dilation ≤ 4 mm (measured by inserting a #4 Hegar dilator through the internal orifice of the cervix uteri immediately prior to IUD insertion
Measured: four hours after misoprostol use
Secondary outcomes (2)
Difficulty in inserting IUD
subjective difficulty (as reported by the investigator) in inserting the IUD and classified as difficult, very difficult and easy
Measured: four hours after misoprostol use
Pain at insertion
judged subjectively by the woman and evaluated by the investigator using a visual analogue scale (VAS). The scale ranged from 0 to 10, in which zero is the absence of pain and 10 the worst pain imaginable.
Measured: four hours after misoprostol use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study startJul 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family PlanningStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melania Amorim, Instituto Materno Infantil Prof. Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490617
- Sponsor's protocol ID
- MISO DIU 01
- Status last verified
- Mar 2018
- First submitted
- 4 Mar 2013
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol Prior To Cupper Intra Uternine Device Insertion In Nullipara: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03490617
- Acronym / sponsor ID
- MISO DIU 01
- Conditions
- Family Planning
- Keywords
- Intrauterine device, Misoprostol, Nulliparous women, Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 6 Apr 2018 (actual)
- 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 use of misoprostol at a dose of 400 µg administered vaginally four hours prior to IUD insertion increased the ease of insertion and reduced the incidence of pain during the procedure, although the frequency of cramps increased following misoprostol use.
Detailed description
Nulligravidas women of reproductive age were submitted to IUD insertion between July 2009 and November 2011 at the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, Brazil. A total of 179 women were randomly allocated to two groups: 86 to use 400 µg of misoprostol vaginally four hours prior to IUD insertion and 93 to use placebo. Risk ratios (RR) were calculated as measures of relative risk, together with their 95% confidence intervals (95%CI). The number needed to treat (NNT) and the number needed to harm (NNH) were also calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Misoprostol Group | Active comparator | Drug: Vaginal misoprostolVaginal misoprostol (400 μg) 4 hours prior to IUD insertion |
| Placebo group | Placebo comparator | Drug: Vaginal misoprostolVaginal placebo tablets 4 hours prior to IUD insertion |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Nulliparous women
- No chirurgical procedure in the cervix
- Wish to use IUD as a contraceptive method
Key exclusion criteria (11 listed)
- Presence of active cervical infection visible upon speculum exam (purulent cervicits)
- Pelvic Inflammatory Disease (PID) or other uterine infection diagnosed within the last 3 months (based on self-report or clinical documentation)
- Pregnancy ending less than 6 weeks prior to enrollment in study
- History of prior IUD placement
- History of uterine cavity abnormality including Mullerian tract anomalies and leiomyomas distorting uterine cavity shape
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 |
|---|---|---|
| Vaginal misoprostolAlso: ProstokosTo determine effectiveness of vaginal misoprostol to facilitate IUD insertion in nulligravida women | Drug | Placebo group, Vaginal Misoprostol Group |
Primary outcome
Cervical dilatation
Time frame: four hours after misoprostol use
the frequency of women with cervical dilation ≤ 4 mm (measured by inserting a #4 Hegar dilator through the internal orifice of the cervix uteri immediately prior to IUD insertion
2 secondary outcomes
Difficulty in inserting IUD
Time frame: four hours after misoprostol use
Pain at insertion
Time frame: four hours after misoprostol use
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 6 Apr 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaginal misoprostol in people with Family Planning, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
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 11 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 6 Apr 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cervical dilatation (time frame: four hours after misoprostol use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2018.