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Completed

NCT Number: NCT02141321

Sub Lingual Misoprostol Before IUD Insertion in Women With Only Previous Cesarean Section

The aim of the work is to evaluate the efficacy of the sub lingual prostaglandin E1 synthetic analogue (misoprostol) before IUD insertion to facilitate the procedure in patients delivered before only by cesarean section.

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Key information

Conditions

IUD Insertion

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University Maternity Hospital

Cairo, Egypt

About this study

The study will be conducted at Ain Shams University Maternity Hospital. 124 women candidate for Cu T 380A IUD insertion will be enrolled in the study. Half of them will receive 400 micro gram of misoprostol (Sigma) sub lingually and the other half will receive the placebo two hours before IUD insertion.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal size uterus.
  • Willing to participate.
  • Candidate for IUD insertion.
  • Delivered only by cesarean section.
  • Last delivery is more than 40 days before participating in the study.

Exclusion criteria

  • Previous vaginal delivery
  • Signs of genital infection.
  • Menopause.
  • Body mass index (BMI) > 35 kg/m2.
  • Contraindication to misoprostol.
  • Copper allergy.
  • Positive pregnancy test.
  • Had a prior attempt for IUD insertion.
  • Uterine anomalies.
  • Uterine fibroid.

Treatment and study plan

Misoprostol

Drug

Other names: Misotac, Cytotec, Misotec, Prostaglandin E1 synthetic analogue

Placebo

Drug

Primary outcomes

  1. Pain

    Time frame: During the procedure

    The perception of pain and discomfort as described by the patient assessed by Visual Analogue Scale (VAS). The scale will be graded from 0 to 10, 0 representing no pain at all and 10 worst possible imaginable pain.

Secondary outcomes

  1. Difficulty of Procedure

    Time frame: During the procedure

    The degree of difficulty of the IUD insertion judged by the investigator as the resistance met at the internal cervical os. The procedure either graded as (easy), (moderate difficulty) or (difficult) or (failed insertion).

  2. Complications

    Time frame: During the procedure and the following 24 hours.

    Uterine perforation, excessive bleeding, fever, IUD expulsion or any other unexpected complications will be assessed during the procedure and followed for the next 24 hours.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

SUB LINGUAL MISOPROSTOL PRIOR TO IUD INSERTION IN WOMEN WITH ONLY PREVIOUS CESARIAN SECTION: A Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 19, 2014
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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