Comparison of Pain Level During Intrauterine Device (IUD) Insertion Between Conventional and Direct Method
NCT ID: NCT03473717
Last Updated: 2018-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
158 participants
INTERVENTIONAL
2018-03-30
2019-03-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct Technique
NCT02595125
Evaluation of the Impact of an Oral and Practical Presentation of Intrauterine Devices by a Health Professional on Women's Opinion as a Possible Contraceptive Method
NCT05317715
DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.
NCT01731132
Quick Start Insertion of Mirena and ParaGard
NCT01730911
Surveillance Study of the Contraceptive Intrauterine Device UT380®
NCT03642171
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
classic method group
IUD/IUS insertion will be done using the conventional method
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 group
IUD/IUS insertion will be done using the direct method
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Having signed informed consent.
* Being affiliated to a social security scheme (excluding AME)
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital
UNKNOWN
EA 7334 Patient-Centered Outcomes Research, University Paris-Diderot
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Catherine Soulat
Role: PRINCIPAL_INVESTIGATOR
CIVG Hôpital Louis Mourier, AP-HP
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Medical Office Gynecology
Paris, , France
Hôpital Trousseau
Paris, , France
ACSBE-La place santé
Saint-Denis, , France
Medical Practice General Practice
Villeneuve-la-Garenne, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HAO 180104
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.