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

NCT03473717 | Unknown

• 1 other identifier: HAO 180104
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 10

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.

Conditions

IUD Insertion

Keywords

pain; Intrauterine device (IUD); Intrauterine system (IUS); Patient-Reported Outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• IUD or SIU localization

  Ultrasound control performed six to ten weeks after the pose.

Study Arms (2)

classic method group

ACTIVE COMPARATOR

IUD/IUS insertion will be done using the conventional method

Device: classic method

direct method group

ACTIVE COMPARATOR

IUD/IUS insertion will be done using the direct method

Device: direct method

Interventions

classic method DEVICE

* 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.

classic method group

direct method DEVICE

* 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

direct method group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: the study concerns women who want IUD or SIU contraception
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital: collaborator
• EA 7334 Patient-Centered Outcomes Research, University Paris-Diderot: collaborator

Study Sites (10)

CIVG Hôpital Avicenne

Bobigny, 93000, France

Location

CIVG Hôpital Louis Mourier

Colombes, 92700, France

Location

Liberal Cabinet Midwife

Courbevoie, 92400, France

Location

Liberal Cabinet Midwife

Fontenay-sous-Bois, 94120, France

Location

Centre de Santé Gatineau Saillant

Gennevilliers, 92230, France

Location

CPEF

Gennevilliers, 92230, France

Location

Medical Office Gynecology

Paris, 75011, France

Location

Hôpital Trousseau

Paris, 75012, France

Location

ACSBE-La place santé

Saint-Denis, 93200, France

Location

Medical Practice General Practice

Villeneuve-la-Garenne, 92390, France

Location

Related Publications (4)

• 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.

  PMID: 24395060 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.

  PMID: 25601352 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.

  PMID: 22015868 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.

  PMID: 23535055 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine Soulat

  CIVG Hôpital Louis Mourier, AP-HP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Soulat, doctor

CONTACT

+33668343890; catsoulat@wanadoo.fr

Charlotte Rambault

CONTACT

+33619430824; charlotte.rambault@laposte.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 22, 2018
• Study Start: March 30, 2018
• Primary Completion: October 15, 2018
• Study Completion: March 15, 2019
• Last Updated: March 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)