Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital | UNKNOWN |
| EA 7334 Patient-Centered Outcomes Research, University Paris-Diderot | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| classic method group | Active Comparator | IUD/IUS insertion will be done using the conventional method |
|
| direct method group | Active Comparator | IUD/IUS insertion will be done using the direct method |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| classic method | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | during the procedure of IUD/IUS insertion |
| Measure | Description | Time Frame |
|---|---|---|
| IUD or SIU localization | localization of IUD/IUS will be controlled by a pelvic ultrasound | Ultrasound control performed six to ten weeks after the pose. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
the study concerns women who want IUD or SIU contraception
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Soulat, doctor | Contact | +33668343890 | catsoulat@wanadoo.fr | |
| Charlotte Rambault | Contact | +33619430824 | charlotte.rambault@laposte.net |
| Name | Affiliation | Role |
|---|---|---|
| Catherine Soulat | CIVG Hôpital Louis Mourier, AP-HP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIVG Hôpital Avicenne | Bobigny | 93000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24395060 | Background | 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. | |
| 25601352 | Background | Heinemann 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. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| direct method | Device |
|
|
| CIVG Hôpital Louis Mourier | Colombes | 92700 | France |
|
| Liberal Cabinet Midwife | Courbevoie | 92400 | France |
|
| Liberal Cabinet Midwife | Fontenay-sous-Bois | 94120 | France |
|
| Centre de Santé Gatineau Saillant | Gennevilliers | 92230 | France |
| CPEF | Gennevilliers | 92230 | France |
|
| Medical Office Gynecology | Paris | 75011 | France |
|
| Hôpital Trousseau | Paris | 75012 | France |
| ACSBE-La place santé | Saint-Denis | 93200 | France |
|
| Medical Practice General Practice | Villeneuve-la-Garenne | 92390 | France |
|
| 22015868 | Background | Braaten 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. |
| 23535055 | Background | Teal 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. |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided