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

Not Applicable

• Conditions: IUD Insertion
• Interventions: Device: classic method; Device: direct method

• Registration Number: NCT03473717
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-21
• Last Update Submitted: 2018-03-21
• Study First Posted: 2018-03-22
• Last Update Posted: 2018-03-22
• Study Start: 2018-03-30
• Primary Completion: 2018-10-15
• Study Completion: 2019-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
classic method group	classic method	IUD/IUS insertion will be done using the conventional method
direct method group	direct method	IUD/IUS insertion will be done using the direct method

Primary Outcome Measures

Name	Time	Method
Pain level during the insertion of IUD or IUS	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)

Secondary Outcome Measures

Name	Time	Method
IUD or SIU localization	Ultrasound control performed six to ten weeks after the pose.	localization of IUD/IUS will be controlled by a pelvic ultrasound

Trial Locations

Locations (9)

Centre de Santé Gatineau Saillant; 🇫🇷 Gennevilliers, France

CPEF; 🇫🇷 Gennevilliers, France

Medical Office Gynecology; 🇫🇷 Paris, France

CIVG Hôpital Louis Mourier; 🇫🇷 Colombes, France

ACSBE-La place santé; 🇫🇷 Saint-Denis, France

Medical Practice General Practice; 🇫🇷 Villeneuve-la-Garenne, France

CIVG Hôpital Avicenne; 🇫🇷 Bobigny, France

Liberal Cabinet Midwife; 🇫🇷 Fontenay-sous-Bois, France

Hôpital Trousseau; 🇫🇷 Paris, France