Status:

UNKNOWN

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

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsors:

URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital

EA 7334 Patient-Centered Outcomes Research, University Paris-Diderot

Conditions:

IUD Insertion

Eligibility:

FEMALE

18-50 years

Phase:

NA

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 tha...

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 cervi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 30 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 15 2019

Estimated Enrollment :

158 Patients enrolled

Trial Details

Trial ID

NCT03473717

Start Date

March 30 2018

End Date

March 15 2019

Last Update

March 22 2018

Active Locations (10)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (10 locations)

1

CIVG Hôpital Avicenne

Bobigny, France, 93000

2

CIVG Hôpital Louis Mourier

Colombes, France, 92700

3

Liberal Cabinet Midwife

Courbevoie, France, 92400

4

Liberal Cabinet Midwife

Fontenay-sous-Bois, France, 94120