IUD InsertionKIDDSNCT03473717
Comparison of Pain Level During Intrauterine Device (IUD) Insertion Between Conventional and Direct Method
A study testing classic method and direct method in people with IUD Insertion, run by Assistance Publique - Hôpitaux de Paris at 10 sites in France.
Trial summary
The so-called "direct" method of intrauterine device (IUD) and intraintuerine system (IUS) insertion is increasingly used. A study has shown that it is technically simpler and assumes less painful than the classic pose. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUD Insertion
- What is being tested?
- classic method and direct method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 10 sitesFrance
- Study dates
- 30 Mar 2018to 15 Mar 2019
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study population will concern all women aged 18 to 50 who want IUD or SIU contraception regardless of whether they are nulliparous, primiparous or pluriparous, whether or not they have had an IUD or IUS.
- Having signed informed consent.
- Being affiliated to a social security scheme (excluding AME)
Who cannot join
- Can not express their consent
- Not mastering French
- With a contraindication to the chosen IUD or IUS.
- Having had local anesthesia of the cervix (in case of Voluntary Interruption of Pregnancy on the day of insertion)
- Having received analgesic treatment within four hours
- Patient without social security
- No consent of the patient
- Minor patient
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CIVG Hôpital Avicenne
Bobigny, 93000
Maud Gelly, 01 48 95 57 71, maud.gelly@aphp.fr
Maud Gelly, Dr
CIVG Hôpital Louis Mourier
Colombes, 92700
Catherine Soulat, 01 47 60 63 51, catsoulat@wanadoo.fr
Françoise Bâcle
Liberal Cabinet Midwife
Courbevoie, 92400
Manon Forthoffer, 06 33 22 48 39, manon.sagefemme@gmail.com
Manon Forthoffer
Liberal Cabinet Midwife
Fontenay-sous-Bois, 94120
Anne Seuront, 06 76 78 35 60, aseurontschneider@free.fr
Anne Seuront
Centre de Santé Gatineau Saillant
Gennevilliers, 92230
CPEF
Gennevilliers, 92230
Anna Christidis, Dr, 01 40 85 66 83, annachristidis@gmail.com
anna Christidis, Dr
Medical Office Gynecology
Paris, 75011
Catherine Soulat, Dr, 01 43 38 00 40, catsoulat@wanadoo.fr
Catherine Soulat, Dr
Hôpital Trousseau
Paris, 75012
ACSBE-La place santé
Saint-Denis, 93200
Cécile Cousyn, Dr, 01 48 09 09 17, cecile.cousyn@gmail.com
Cécile Cousyn, Dr
Medical Practice General Practice
Villeneuve-la-Garenne, 92390
Françoise Bâcle, Dr, 01 40 85 05 02, fbacle@laposte.net
Françoise Bâcle, dr
About this study
Official title: Comparaison de la Douleur Lors de la Pose Des DIU et SIU Entre la méthode Classique et la méthode Directe
The so-called "direct" method of intrauterine device (IUD) and intraintuerine system (IUS) insertion is increasingly used. A study has shown that it is technically simpler and assumes less painful than the classic pose.
It seems interesting to compare the pain felt by the patients during IUD / IUS insertion in these two methods of placement and also to confirm that there is no more malposition with the direct method.
Read the detailed description
The classic method uses: a Pozzi for pulling the uterus to horizontalize it and a hysterometer to visualize the axis of the uterus and to measure the distance between the external orifice of the cervix and the uterine fundus in order to deploy the IUD / IUS.
In the so-called direct technique, the operator does not measure the depth of the uterus thanks to a hysterometer and does not draw the cervix with a Pozzi forceps, the IUD / IUS is deployed as soon as the orifice passes. inside the cervix and the inserter tube does not enter the uterine cavity. With this method the Pozzi forceps is only used as a second line, especially in case of a fleeing neck.
- Conditions
- IUD Insertion
- Being tested
- classic method, direct method
- Keywords
- pain, Intrauterine device (IUD), Intrauterine system (IUS), Patient-Reported Outcome
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classic methodDevice
- Put the Pozzi forceps to draw the uterus by the cervix to horizontalize it and align uterine cavity in the direct axis of cervix.
- Insert the hysterometer to measure the uterus depth.
- Locate the uterine depth on the inserter tube.
direct methodDevice
- Place the ring on the inserter tube 3 to 4 cm from the end as a marker.
- Insert the tube into the cervix until you feel the passage of the internal orifice of the cervix or until the ring is in contact with the external orifice of the cervix, the tube does not enter the uterine cavity
| Study group | Role | What they receive |
|---|---|---|
| classic method group | Active comparator | IUD/IUS insertion will be done using the conventional method Receives: Device: classic method |
| direct method group | Active comparator | IUD/IUS insertion will be done using the direct method Receives: Device: direct method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level during the insertion of IUD or IUS
Evaluation endpoint is pain felt by the patient during insertion of the IUD or IUS by a 0-100 mm standard visual analog scale (VAS)
Measured: during the procedure of IUD/IUS insertion
Secondary outcomes (1)
IUD or SIU localization
localization of IUD/IUS will be controlled by a pelvic ultrasound
Measured: Ultrasound control performed six to ten weeks after the pose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start30 Mar 2018 (estimated)
- Primary completion15 Oct 2018 (estimated)
- Study completion15 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for IUD InsertionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital, EA 7334 Patient-Centered Outcomes Research, University Paris-Diderot
- Responsible party
- Sponsor
- Investigators
- Catherine Soulat, Principal investigator, CIVG Hôpital Louis Mourier, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473717
- Sponsor's protocol ID
- HAO 180104
- Acronym
- KIDDS
- Status last verified
- Feb 2018
- First submitted
- 9 Mar 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Golightly E, Gebbie AE. Low-lying or malpositioned intrauterine devices and systems. J Fam Plann Reprod Health Care. 2014 Apr;40(2):108-12. doi: 10.1136/jfprhc-2013-100684. Epub 2014 Jan 6.
PubMed 24395060Heinemann K, Reed S, Moehner S, Minh TD. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015 Apr;91(4):274-9. doi: 10.1016/j.contraception.2015.01.007. Epub 2015 Jan 16.
PubMed 25601352Braaten KP, Benson CB, Maurer R, Goldberg AB. Malpositioned intrauterine contraceptive devices: risk factors, outcomes, and future pregnancies. Obstet Gynecol. 2011 Nov;118(5):1014-1020. doi: 10.1097/AOG.0b013e3182316308.
PubMed 22015868Teal SB, Romer SE. Awareness of long-acting reversible contraception among teens and young adults. J Adolesc Health. 2013 Apr;52(4 Suppl):S35-9. doi: 10.1016/j.jadohealth.2013.01.013.
PubMed 23535055
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparaison de la Douleur Lors de la Pose Des DIU et SIU Entre la méthode Classique et la méthode Directe
- ClinicalTrials.gov ID
- NCT03473717
- Acronym / sponsor ID
- KIDDS / HAO 180104
- Conditions
- IUD Insertion
- Keywords
- pain, Intrauterine device (IUD), Intrauterine system (IUS), Patient-Reported Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital, EA 7334 Patient-Centered Outcomes Research, University Paris-Diderot
- Study start
- 30 Mar 2018 (estimated)
- Primary completion
- 15 Oct 2018 (estimated)
- Study completion
- 15 Mar 2019 (estimated)
- First posted
- 22 Mar 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 so-called "direct" method of intrauterine device (IUD) and intraintuerine system (IUS) insertion is increasingly used. A study has shown that it is technically simpler and assumes less painful than the classic pose.
It seems interesting to compare the pain felt by the patients during IUD / IUS insertion in these two methods of placement and also to confirm that there is no more malposition with the direct method.
Detailed description
The classic method uses: a Pozzi for pulling the uterus to horizontalize it and a hysterometer to visualize the axis of the uterus and to measure the distance between the external orifice of the cervix and the uterine fundus in order to deploy the IUD / IUS.
In the so-called direct technique, the operator does not measure the depth of the uterus thanks to a hysterometer and does not draw the cervix with a Pozzi forceps, the IUD / IUS is deployed as soon as the orifice passes. inside the cervix and the inserter tube does not enter the uterine cavity. With this method the Pozzi forceps is only used as a second line, especially in case of a fleeing neck.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classic method group | Active comparator | Device: classic methodIUD/IUS insertion will be done using the conventional method |
| direct method group | Active comparator | Device: direct methodIUD/IUS insertion will be done using the direct method |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The study population will concern all women aged 18 to 50 who want IUD or SIU contraception regardless of whether they are nulliparous, primiparous or pluriparous, whether or not they have had an IUD or IUS.
- Having signed informed consent.
- Being affiliated to a social security scheme (excluding AME)
Key exclusion criteria (8 listed)
- Can not express their consent
- Not mastering French
- With a contraindication to the chosen IUD or IUS.
- Having had local anesthesia of the cervix (in case of Voluntary Interruption of Pregnancy on the day of insertion)
- Having received analgesic treatment within four hours
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 |
|---|---|---|
| classic method* Put the Pozzi forceps to draw the uterus by the cervix to horizontalize it and align uterine cavity in the direct axis of cervix. * Insert the hysterometer to measure the uterus depth. * Locate the uterine depth on the inserter tube. | Device | classic method group |
| direct method* Place the ring on the inserter tube 3 to 4 cm from the end as a marker. * Insert the tube into the cervix until you feel the passage of the internal orifice of the cervix or until the ring is in contact with the external orifice of the cervix, the tube does not enter the uterine cavity | Device | direct method group |
Primary outcome
Pain level during the insertion of IUD or IUS
Time frame: during the procedure of IUD/IUS insertion
Evaluation endpoint is pain felt by the patient during insertion of the IUD or IUS by a 0-100 mm standard visual analog scale (VAS)
1 secondary outcome
IUD or SIU localization
Time frame: Ultrasound control performed six to ten weeks after the pose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Background: PubMed 24395060Golightly E, Gebbie AE. Low-lying or malpositioned intrauterine devices and systems. J Fam Plann Reprod Health Care. 2014 Apr;40(2):108-12. doi: 10.1136/jfprhc-2013-100684. Epub 2014 Jan 6.
- Background: PubMed 25601352Heinemann K, Reed S, Moehner S, Minh TD. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015 Apr;91(4):274-9. doi: 10.1016/j.contraception.2015.01.007. Epub 2015 Jan 16.
- Background: PubMed 22015868Braaten KP, Benson CB, Maurer R, Goldberg AB. Malpositioned intrauterine contraceptive devices: risk factors, outcomes, and future pregnancies. Obstet Gynecol. 2011 Nov;118(5):1014-1020. doi: 10.1097/AOG.0b013e3182316308.
- Background: PubMed 23535055Teal SB, Romer SE. Awareness of long-acting reversible contraception among teens and young adults. J Adolesc Health. 2013 Apr;52(4 Suppl):S35-9. doi: 10.1016/j.jadohealth.2013.01.013.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Catherine Soulat principal investigator
CIVG Hôpital Louis Mourier, AP-HP
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing classic method and direct method in people with IUD Insertion, run by Assistance Publique - Hôpitaux de Paris at 10 sites 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 3 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: status not confirmed, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Soulat, doctor (+33668343890, catsoulat@wanadoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level during the insertion of IUD or IUS (time frame: during the procedure of IUD/IUS 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 NCT03473717, which also lists 4 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 22 Mar 2018.