Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion

Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion Following Previous Insertion Failure

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

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Misoprostol; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Abbassya
    • Cairo, Abbassya, Egypt, 11566
      • AinShams university maternity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; vaginal misoprostol prior IUD insertion
Placebo Comparator: placebo; while the control group received a placebo tablet in the same regimen as the study group.	Drug: Placebos; vaginal placebo tablet prior IUD insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the success rate for IUD insertion.	the success of IUD insertion after previous attempt failure	four hours after misoprostol dose

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (Actual): December 31, 2018

Study Record Updates

• Last Update Posted (Actual): December 31, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: Ain Shams University MH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No