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

NCT05204979 | Unknown

• 1 other identifier: THESIS FOR PARTIA
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IUD Insertion

Keywords

Misoprostol

Outcome Measures

Primary Outcomes (1)

• The proportion of easy IUD Insertion

  Difficulty of IUD insertion will be measured by cervical dilatation that determined by two factors: 1. Degree of dilatation of cervix by using gradual Hegar 1, 2, 3. 2. 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 Outcomes (1)

• the pain during insertion

  24 hours

Study Arms (1)

Misopristol

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

Other: Vaginal Versus Sublingual misoprostol

Interventions

Vaginal Versus Sublingual misoprostol OTHER

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.

Misopristol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11865, Egypt

RECRUITING

Study Officials

• Hassan MD awad, consultant

  professor

  STUDY CHAIR

• Rofida M Taha, doctor

  doctor

  STUDY CHAIR

Central Study Contacts

Rofida M Taha, doctor

CONTACT

+2 01284604696; RofidaMohamed@med.asu.edu.eg

dr h awaad, doctor

CONTACT

+2 01067769215; engahmedhassib@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: January 24, 2022
• Study Start: June 23, 2021
• Primary Completion: February 17, 2022
• Study Completion: May 25, 2022
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)