Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion

Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion in Nulliparous Women: a Randomized Controlled Trial

the aim of the present study is to Compare Safety and Efficacy of Vaginal dinoprostone Versus Lidocaine-prilocaine Cream in copper IUD Insertion in nulliparous women: a randomized controlled trial

Study Overview

• Status: Unknown
• Conditions: Contraception
• Intervention / Treatment: Drug: vaginal dinoprostone; Drug: Lidocaine-prilocaine Cream; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• nulliparous women requesting copper IUD insertion

Exclusion Criteria:

• multiparous women, active vaginal or cervical infections and contraindications to IUD Insertion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vaginal dinoprostone; vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion.	Drug: vaginal dinoprostone; vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion
Active Comparator: lidocaine prilocaine cream; Lidocaine-prilocaine Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion	Drug: Lidocaine-prilocaine Cream; Lidocaine-prilocaine Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion
Placebo Comparator: placebo; inert placebo Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion	Drug: placebo; inert placebo Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain during IUD insertion: visual analog scale	pain during copper IUD insertion evaluated by 10 cm visual analog scale where 0 denotes no pain and 10 cm denotes the worst pain imaginable	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of insertion	duration of insertion from speculum in to speculum out	5 minutes

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2020
• Primary Completion (Anticipated): August 30, 2020
• Study Completion (Anticipated): September 5, 2020

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Reproductive Control Agents; Oxytocics; Anesthetics, Combined; Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination; Dinoprostone
• Other Study ID Numbers: dinoprostone vs LP cream

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No