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CompletedNCT03790371Updated Dec 31, 2018

Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion

A Phase 3 interventional study of Misoprostol and Placebos in Contraception, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 44 Years. Per ClinicalTrials.gov, last updated 2018-12-31.

Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Oct 2015, registered Dec 2018).
Phase
Phase 3
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 44 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Contraception
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

One previous failed attempt of IUD insertion.

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    misoprostol group

    misoprostol (misotac® sigma pharmaceutical industries) 200 mcg vaginally applied ten and four hours prior to the second attempt of IUD insertion

    Drug: Misoprostol

  • Placebo comparator
    placebo

    while the control group received a placebo tablet in the same regimen as the study group.

    Drug: Placebos

Interventions

  • DrugMisoprostol

    vaginal misoprostol prior IUD insertion

  • DrugPlacebos

    vaginal placebo tablet prior IUD insertion

06

What researchers measure

Primary outcomes

  1. the success rate for IUD insertion.

    the success of IUD insertion after previous attempt failure

    Time frame: four hours after misoprostol dose

07

Study locations

1 site
  • AinShams university maternity hospital
    Cairo, Abbassya 11566, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03790371
Lead sponsor
Ain Shams University
Responsible party
Radwa Rasheedy Ali (Principal Investigator, Ain Shams University) — Principal investigator
First posted
Dec 31, 2018
Start date
Oct 1, 2015
Primary completion
Aug 1, 2016
Completion
Aug 1, 2016
Last update
Dec 31, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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