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

IUD Insertion Clinical Trial

— KIDDS  

Official title:

Comparaison de la Douleur Lors de la Pose Des DIU et SIU Entre la méthode Classique et la méthode Directe

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03473717
• Other study ID #: HAO 180104
• Status: Not yet recruiting
• Phase: N/A
• First received: March 9, 2018
• Last updated: March 21, 2018
• Start date: March 30, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: February 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Catherine Soulat, doctor
• Phone: +33668343890
• Email: catsoulat[@]wanadoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 158
• Est. completion date: March 15, 2019
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• IUD Insertion

Intervention

Device:
• 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.
• 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

Locations

Country	Name	City	State
France	CIVG Hôpital Avicenne	Bobigny
France	CIVG Hôpital Louis Mourier	Colombes
France	Liberal Cabinet Midwife	Courbevoie
France	Liberal Cabinet Midwife	Fontenay-sous-Bois
France	Centre de Santé Gatineau Saillant	Gennevilliers
France	CPEF	Gennevilliers
France	Hôpital Trousseau	Paris
France	Medical Office Gynecology	Paris
France	ACSBE-La place santé	Saint-Denis
France	Medical Practice General Practice	Villeneuve-la-Garenne

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	EA 7334 Patient-Centered Outcomes Research, University Paris-Diderot, URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital

Country where clinical trial is conducted

France, 

References & Publications (4)

Braaten KP, Benson CB, Maurer R, Goldberg AB. Malpositioned intrauterine contraceptive devices: risk factors, outcomes, and future pregnancies. Obstet Gynecol. 2011 Nov;118(5):1014-20. doi: 10.1097/AOG.0b013e3182316308. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.

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