Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion
1 other identifier
interventional
210
0 countries
N/A
Brief Summary
the aim of the present study is to Compare Safety and Efficacy of Vaginal dinoprostone Versus Lidocaine-prilocaine Cream in copper IUD Insertion in nulliparous women: a randomized controlled trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2020
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2020
CompletedFirst Posted
Study publicly available on registry
April 10, 2020
CompletedStudy Start
First participant enrolled
April 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2020
CompletedApril 10, 2020
April 1, 2020
4 months
April 7, 2020
April 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
pain during IUD insertion: visual analog scale
pain during copper IUD insertion evaluated by 10 cm visual analog scale where 0 denotes no pain and 10 cm denotes the worst pain imaginable
5 minutes
Secondary Outcomes (1)
duration of insertion
5 minutes
Study Arms (3)
vaginal dinoprostone
EXPERIMENTALvaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion.
lidocaine prilocaine cream
ACTIVE COMPARATORLidocaine-prilocaine Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion
placebo
PLACEBO COMPARATORinert placebo Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion
Interventions
vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion
Lidocaine-prilocaine Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion
inert placebo Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion
Eligibility Criteria
You may qualify if:
- nulliparous women requesting copper IUD insertion
You may not qualify if:
- multiparous women, active vaginal or cervical infections and contraindications to IUD Insertion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor obstetrics and gynecology
Study Record Dates
First Submitted
April 7, 2020
First Posted
April 10, 2020
Study Start
April 30, 2020
Primary Completion
August 30, 2020
Study Completion
September 5, 2020
Last Updated
April 10, 2020
Record last verified: 2020-04