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)
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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