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NCT03790371 Clinical Trial

Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion

Contraception Clinical Trial

Official title:
Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion Following Previous Insertion Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03790371
Other study ID # Ain Shams University MH
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 1, 2015
Est. completion date August 1, 2016

Study information
Verified date December 2018
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the current study was conducted to assess efficacy of vaginal misoprostol before IUD insertion following previous insertion failure

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date August 1, 2016
Est. primary completion date August 1, 2016
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 44 Years
Eligibility Inclusion Criteria:

One previous failed attempt of IUD insertion.

Exclusion Criteria:

1. Uterine fibroid distorting the cavity.

2. Anatomical uterine abnormality with distortion of the cavity

3. Current pelvic inflammatory disease or recently treated pelvic inflammatory disease (PID) in the last three months.

4. Current purulent cervicitis (chlamydia or gonorrhea).

5. Immediately after septic abortion.

6. Uterus size less than 6 cm and more than 9 cm.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Misoprostol
vaginal misoprostol prior IUD insertion
• Placebos
vaginal placebo tablet prior IUD insertion

Locations
Country Name City State
Egypt AinShams university maternity hospital Cairo Abbassya

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary the success rate for IUD insertion. the success of IUD insertion after previous attempt failure four hours after misoprostol dose
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