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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04339361
Other study ID # lidocaine spray IUD
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date April 25, 2020
Est. completion date August 15, 2020

Study information

Verified date April 2020
Source Cairo University
Contact AHMED SAMY
Phone +201100681167
Email ahmedsamy8233@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the aim of this study is to compare the safety and Efficacy of Lidocaine Spray Versus Vaginal dinoprostone in relieving pain during levonorgestrel IUD Insertion in nulliparous women


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 111
Est. completion date August 15, 2020
Est. primary completion date August 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- nulliparous women requesting levonorgestrel IUD insertion

Exclusion Criteria:

- multiparous women, allergy or contraindication to study drugs or contraindications to LNG-IUD insertion

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
lidocaine spray
four puffs (50 ml, 10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion
vaginal dinoprostone
vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
placebo
vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary pain during IUD insertion pain during IUD insertion assessed by 10 cm visual analog scale where 0 denotes no pain and 10 denotes the worst pain imaginable 2 minutes
Secondary insertion duration duration of LNG-IUD insertion from speculum in to speculum out 5 minutes
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