ContraceptionDIRECTENCT02595125
Study Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct Technique
A study testing IUD in people with Contraception, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Intrauterine devices (IUDs) are contraceptive methods of long-acting (from 3 to 10 years depending on the model) and among the most effective. However, there are many obstacles to the use of IUDs including pain felt by patients during installation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraception
- What is being tested?
- IUD
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2016to 19 Jul 2017
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any major patient and consultant for IUD insertion : hormonal or copper
- Signing of the information and consent form by the patient or, if under supervision by parents or guardian.
- Patient affiliated with or entitled to a social security scheme
- No contraindication for IUD insertion
Who cannot join
- Patient consultant for IUD insertion to side arms
- Contraindications for installation.
- Legal incapacity or limited legal capacity. Medical or psychological conditions not allowing the subject to understand the study and sign the consent
- Refusal to sign the consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study, Prospective, Randomized , Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct Technique. A Monocentric Study
Intrauterine devices (IUDs) are contraceptive methods of long-acting (from 3 to 10 years depending on the model) and among the most effective. However, there are many obstacles to the use of IUDs including pain felt by patients during installation. Several medical means were studied without evidence of their efficacy in pain related to IUD insertion. In order to remove this brake, it's important to find another way to act against this pain. The direct technique is one of the techniques described by health professionals. It seems trusted by its users as a more reliable technique but also less painful for patients. However, there is no study available on its evaluation. The aim of this study is to investigate the interest of the direct technique in reducing the pain experienced by patients during installation.
- Conditions
- Contraception
- Being tested
- IUD
- Keywords
- intrauterine device, contraceptive method, direct technique, torpedo technique, verbal numeric scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUDDevice
copper IUD or levonogestrel IUD insert by the conventional technique or by direct technique
| Study group | Role | What they receive |
|---|---|---|
| Conventional technique | Sham comparator | Intrauterine device (IUD) insertion by the conventional technique Receives: Device: IUD |
| Direct technique | Experimental | Intrauterine device (IUD) insertion by the direct technique Receives: Device: IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured by Verbal Numeric Scale
Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be)
Measured: intraoperative
Secondary outcomes (9)
Number of failure laying direct technique
Measured: intraoperative
Number of vagal discomfort
Measured: intraoperative
Number of expulsion of the IUD
Measured: intraoperative
Number of IUD-fond uterine distance >2 cm
Measured: intraoperative
Number of expulsion of IUD
Measured: up to 7 days
Number of emergency department visit for a IUD complication
Measured: up to 7 days
Number of analgesic intake
Measured: up to 7 days post-insertion
Pain measured by Verbal Numeric Scale
Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be)
Measured: day 1
Pain measured by Verbal Numeric Scale
Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be)
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start24 Feb 2016
- Primary completion12 Jul 2017
- Study completion19 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline Chauleur, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595125
- Sponsor's protocol ID
- 1508153
- Other IDs
- 2015-A01966-43
- Acronym
- DIRECTE
- Status last verified
- Jan 2018
- First submitted
- 2 Nov 2015
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study, Prospective, Randomized , Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct Technique. A Monocentric Study
- ClinicalTrials.gov ID
- NCT02595125
- Acronym / sponsor ID
- DIRECTE / 1508153
- Conditions
- Contraception
- Keywords
- intrauterine device, contraceptive method, direct technique, torpedo technique, verbal numeric scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 24 Feb 2016 (actual)
- Primary completion
- 12 Jul 2017 (actual)
- Study completion
- 19 Jul 2017 (actual)
- First posted
- 3 Nov 2015 (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.
Intrauterine devices (IUDs) are contraceptive methods of long-acting (from 3 to 10 years depending on the model) and among the most effective. However, there are many obstacles to the use of IUDs including pain felt by patients during installation. Several medical means were studied without evidence of their efficacy in pain related to IUD insertion. In order to remove this brake, it's important to find another way to act against this pain. The direct technique is one of the techniques described by health professionals. It seems trusted by its users as a more reliable technique but also less painful for patients. However, there is no study available on its evaluation. The aim of this study is to investigate the interest of the direct technique in reducing the pain experienced by patients during installation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional technique | Sham comparator | Device: IUDIntrauterine device (IUD) insertion by the conventional technique |
| Direct technique | Experimental | Device: IUDIntrauterine device (IUD) insertion by the direct technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any major patient and consultant for IUD insertion : hormonal or copper
- Signing of the information and consent form by the patient or, if under supervision by parents or guardian.
- Patient affiliated with or entitled to a social security scheme
- No contraindication for IUD insertion
Key exclusion criteria (4 listed)
- Patient consultant for IUD insertion to side arms
- Contraindications for installation.
- Legal incapacity or limited legal capacity. Medical or psychological conditions not allowing the subject to understand the study and sign the consent
- Refusal to sign the consent.
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 |
|---|---|---|
| IUDcopper IUD or levonogestrel IUD insert by the conventional technique or by direct technique | Device | Conventional technique, Direct technique |
Primary outcome
Pain measured by Verbal Numeric Scale
Time frame: intraoperative
Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be)
9 secondary outcomes
Number of failure laying direct technique
Time frame: intraoperative
Number of vagal discomfort
Time frame: intraoperative
Number of expulsion of the IUD
Time frame: intraoperative
Number of IUD-fond uterine distance >2 cm
Time frame: intraoperative
Number of expulsion of IUD
Time frame: up to 7 days
Number of emergency department visit for a IUD complication
Time frame: up to 7 days
Number of analgesic intake
Time frame: up to 7 days post-insertion
Pain measured by Verbal Numeric Scale
Time frame: day 1
Pain measured by Verbal Numeric Scale
Time frame: day 7
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 29 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
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.
Céline Chauleur, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IUD in people with Contraception, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 4 inclusion and 4 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 29 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 France. 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?
Pain measured by Verbal Numeric Scale (time frame: intraoperative). 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 29 Jan 2018.