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

NCT03473717 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2018-03-22

No results posted yet for this study

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

Interventions

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.

DEVICE

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

Sponsors & Collaborators

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

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Catherine Soulat · CIVG Hôpital Louis Mourier, AP-HP

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-30
Primary Completion
2018-10-15
Completion
2019-03-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03473717 on ClinicalTrials.gov