Vaginal Vs Subling Misoprost Before Iud Insertion in Women With Previous CS

Vaginal Versus Sublingual Misoprostol Before Intrauterine Device Insertion in Women With Pervious Caesarian Section

Insertion failures of intrauterine devices and cervical problems seem to occur more often among women who have never delivered vaginally. This trial will compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.

Study Overview

• Status: Recruiting
• Conditions: IUD Insertion
• Intervention / Treatment: Other: Vaginal Versus Sublingual misoprostol

Detailed Description

Intrauterine devices (IUDs) are widely used as reversible contraceptives. The current use of IUDs among reproductive-aged women ranges from 8 to 15% worldwide. Reported complications related to IUD insertion are 8.8% insertion failure, 2.8-11.5% cervical problems, 0.2% cervical perforation, 0.2% syncope and 5.8% expulsion. Insertion failures and cervical problems seem to occur more often among women who have never delivered vaginally.

Misoprostol is an inexpensive PGE1. Priming with misoprostol prior to hysteroscopy and dilatation and curettage (D&C) in premenopausal women resulted in an increased cervical dilatation and rate of cervical laceration. Moreover, several studies have shown the benefit of misoprostol as a cervical ripening agent in nonpregnant women. The effect of misoprostol is dependent on the route of administration. Sublingual administration of misoprostol has been shown to be more effective also for cervical priming compared with oral administration and equally effective as vaginal administration.

larger studies on the effect of misoprostol for IUD insertion are lacking. Investigator therefore will conduct a trial aiming to compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.

• Study Type: Observational
• Enrollment (Anticipated): 2

Contacts and Locations

• Study Contact: Name: Rofida M Taha, doctor; Phone Number: +2 01284604696; Email: RofidaMohamed@med.asu.edu.eg
• Study Contact Backup: Name: dr h awaad, doctor; Phone Number: +2 01067769215; Email: engahmedhassib@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Recruiting
    • Ain shams university
    • Contact: dr h awwad; Phone Number: +202-24346344; Email: dean@med.asu.edu.eg
    • Contact: RofIda M Taha, doctor
    • Principal Investigator: Rofida M Taha, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The study will be conducted on multiparous women delivered only by CS seeking intra uterine device insertion

Description

Inclusion Criteria:

Women at the reproductive age group between 20-40 years Women who previously delivered by cesarean section. Women with BMI between 20- 30.

Exclusion Criteria:

Women had a previous vaginal operations. Women with contraindications for misoprostol use (pregnancy, prostaglandin allergy) Women with a contraindication for IUCD insertion (e.g., less than sex weeks post-partum, gynecologic malignancy, uterine bleeding of undetermined origin, fibroids or other uterine abnormalities, active vaginitis or cervicitis, a history of PID or puerperal sepsis).

Women on anticoagulant therapy or having any coagulopathy. Women who refused to participate.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Misopristol; Group A: vaginal misoprostol will be taken Group B: sublingual misoprostol will be taken

Other: Vaginal Versus Sublingual misoprostol; Insertion failures of intra uterine devices and cervical problems seem to occur more often among women who have never delivered vaginally. Several studies have shown the benefit of misoprostol as a cervical ripening agent in nonpregnant women. This trial will compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of easy IUD Insertion	Difficulty of IUD insertion will be measured by cervical dilatation that determined by two factors: Degree of dilatation of cervix by using gradual Hegar 1, 2, 3.; The degree of difficulty of the IUD insertion judged as the resistance of the internal cervical os experienced by the investigator and classified as 'easy', 'moderate' or 'difficult'. [Time Frame: Easy: Using Hegar 3 and easy of difficulty of insertion. Moderate: Using Hegar 2 and moderate of difficulty of insertion. Difficult: Using Hegar 1 and difficult of difficulty of insertion]	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the pain during insertion	Pain will be measured using a visual analog scale (VAS) pain score reported by participants during IUD insertion. Pain score will be measured using a visual analogue scale consisting of a 10 cm horizontal straight line on which 0 cm corresponds to no pain and 10 cm to the worst pain. VAS is rated as 0 no pain. 1-3 for mild pain. 4-6 for average pain and 7-9 for severe pain and 10 for extremely sever pain an individual can experience.	24 hours

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Hassan MD awad, consultant, PROFESSOR; Study Chair: Rofida M Taha, doctor, doctor

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Anticipated): February 17, 2022
• Study Completion (Anticipated): May 25, 2022

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Misoprostol
• 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: THESIS FOR PARTIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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