Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women

NCT04505917 | Unknown DMC

• 1 other identifier: aswu/352/4/19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD insertion pain and the difficulty in inserting the IUD in multiparous overweight and obese women

Conditions

IUCD Complication

Outcome Measures

Primary Outcomes (1)

• The difference in visual analog scale pain scores during intrauterine device insertion

  The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10

  10 minuts

Secondary Outcomes (4)

• Intensity of pain: visual analogue scale

  30 minutes after the procedure

• the difference in visual analog scale pain scores during tenaculum application

  10 minutes

• the ease of IUD insertion

  10 minutes

• women's satisfaction level: score

  10 minutes

Study Arms (3)

dinoprostone

EXPERIMENTAL

2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.

Drug: dinoprostol

misoprostol

ACTIVE COMPARATOR

2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.

Drug: misoprostol

placebo

PLACEBO COMPARATOR

Placebo Comparator: placebo 2 tablet of placebo inserted by the study nurse 3 hours before IUD insertion.

Drug: placebo

Interventions

dinoprostol DRUG

2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.

Also known as: prostin

dinoprostone

misoprostol DRUG

2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.

Also known as: Misotac

misoprostol

placebo DRUG

2 tablet of placebo inserted by the study nurse 3 hours before IUD insertion

Also known as: placebo comparator

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: multipara overweight and obese women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• multi parous women requesting copper IUD insertion
• body mass index more than 25

You may not qualify if:

• pregnancy,
• null parous women,
• contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion,
• untreated active cervicitis or vaginitis,
• undiagnosed abnormal uterine bleeding

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Interventions

KLK15 protein, human; Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• nahla w Shady, md

  Aswan universirty

  STUDY CHAIR

Central Study Contacts

hany f Sallam, md

CONTACT

+20102435461; hany.farouk@aswu.edu.eg

nahla w Shady, md

CONTACT

+201022336052; hanygyne@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind randomized controlled trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Professor

Model Details: double blind randomized controlled trial

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 10, 2020
• Study Start: September 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: August 30, 2021
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)