Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion

Comparison of Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion in Nulliparous Women : a Randomized Controlled Study

To compare the effect of vaginal dinoprostone versus vaginal misoprostol and Isonicotinic Acid Hydrazide administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in inserting the IUD in nulliparous women.

Study Overview

• Status: Unknown
• Conditions: IUCD Complication
• Intervention / Treatment: Drug: Isonicotinic Acid Hydrazide; Drug: dinoprostine; Drug: misoprostol

Detailed Description

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan University Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• nulliparous women requesting copper IUD insertion

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: isonicotinic acid hydrazide; 2vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.	Drug: Isonicotinic Acid Hydrazide; 2 vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.; Other Names: INH
Active Comparator: dinoprostone; 2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 12 hours before IUD insertion.	Drug: dinoprostine; 2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.; Other Names: prostin
Active Comparator: misoprostol; 2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 12hours before IUD insertion.	Drug: misoprostol; 2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion; Other Names: Misotac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the ease of IUD insertion	the ease of IUD insertion using ease of insertion score from 0 to 10 cm (0 = very easy insertion, 10 cm = terribly difficult insertion)	10 minutes
women's satisfaction level: score	women's satisfaction level using satisfaction score from 0 to 10 cm where 0 denotes no satisfaction and 10 denotes maximum satisfaction	10 minutes
the difference in visual analog scale pain scores during tenaculum application	The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10	10 minuts

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 15, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Anti-Bacterial Agents; Reproductive Control Agents; Anti-Ulcer Agents; Antitubercular Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Fatty Acid Synthesis Inhibitors; Misoprostol; Isoniazid
• Other Study ID Numbers: aswu/352/5/19

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