Comparison of Pain Level During Intrauterine Device (IUD) Insertion Between Conventional and Direct Method

Assistance Publique - Hôpitaux de Paris158 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

158

Conditions

IUD Insertion

Interventions

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

CIVG Hôpital Avicenne

Bobigny, France

CIVG Hôpital Louis Mourier

Colombes, France

Liberal Cabinet Midwife

Courbevoie, France

Liberal Cabinet Midwife

Fontenay-sous-Bois, France

Outcomes

Primary Outcomes

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)

Time frame: during the procedure of IUD/IUS insertion

Secondary Outcomes

IUD or SIU localization

localization of IUD/IUS will be controlled by a pelvic ultrasound

Time frame: Ultrasound control performed six to ten weeks after the pose.

Central Contacts

Catherine Soulat, doctor

CONTACT

+33668343890 catsoulat@wanadoo.fr

Charlotte Rambault

CONTACT

+33619430824 charlotte.rambault@laposte.net

Data from ClinicalTrials.gov

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