Clinical trial NCT03473717: Comparison of Pain Level During Intrauterine Device (IUD) Insertion Between Conventional and Direct Method
Official title: Comparaison de la Douleur Lors de la Pose Des DIU et SIU Entre la méthode Classique et la méthode Directe
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IUD Insertion
Keywords: pain
Intrauterine device (IUD)
Intrauterine system (IUS)
Patient-Reported Outcome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital
name: EA 7334 Patient-Centered Outcomes Research, University Paris-Diderot
First posted: 2018-03-22
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain level during the insertion of IUD or IUS
timeFrame: during the procedure of IUD/IUS insertion
Secondary outcomes:
measure: IUD or SIU localization
timeFrame: Ultrasound control performed six to ten weeks after the pose.
Other outcomes:
Locations:
city: Bobigny
country: France
facility: CIVG Hôpital Avicenne
city: Colombes
country: France
facility: CIVG Hôpital Louis Mourier
city: Courbevoie
country: France
facility: Liberal Cabinet Midwife
city: Fontenay-sous-Bois
country: France
facility: Liberal Cabinet Midwife
city: Gennevilliers
country: France
facility: Centre de Santé Gatineau Saillant
city: Gennevilliers
country: France
facility: CPEF
city: Paris
country: France
facility: Medical Office Gynecology
city: Paris
country: France
facility: Hôpital Trousseau
city: Saint-Denis
country: France
facility: ACSBE-La place santé
city: Villeneuve-la-Garenne
country: France
facility: Medical Practice General Practice
Study officials:
affiliation: CIVG Hôpital Louis Mourier, AP-HP
name: Catherine Soulat
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.