Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Levonorgestrel IUD Insertion

May 5, 2021 updated by: Ahmed Samy aly ashour, Cairo University

Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Reducing Pain During Levonorgestrel IUD Insertion in Women Delivered Only by Cesarean Deliveries

the aim of the present study is to compare the safety and Efficacy of vaginal misoprostol versus Lidocaine-prilocaine cream in reducing pain during levonorgestrel IUD Insertion in women delivered only by cesarean deliveries

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 12511
        • Ahmedsamy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women who delivered only by previous cesarean delivery and requesting LNG-IUD insertion

Exclusion Criteria:

  • women who delivered vaginally, active vaginal or cervical infections and contraindications to IUD insertion or study drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: vaginal misoprostol
vaginal misoprostol 200 mcg will be given 3 hours before LNG-IUD insertion plus vaginal inert placebo cream at the time of IUD insertion
Drug: vaginal misoprostol
vaginal misoprostol 200 mcg will be given 3 hours before LNG-IUD insertion plus inert placebo cream vaginally at the time of LNG-IUD insertion
ACTIVE_COMPARATOR: lidocaine prilocaine cream
Lidocaine-prilocaine anesthetic cream will be placed on the cervix at the time of IUD insertion plus vaginal placebo will be given 3 hours before LNG-IUD insertion
Drug: Lidocaine-Prilocaine Topical cream
Lidocaine-Prilocaine cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion
PLACEBO_COMPARATOR: placebo
inert vaginal placebo cream will be placed on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours before LNG-IUD insertion
Drug: placebo
inert placebo cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of insertion
Time Frame: 5 minutes
duration of LNG-IUD insertion from speculum in to speculum out
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: ahmed taher, MD, Cairo University
  • Principal Investigator: sherif dahab, MD, Cairo University
  • Principal Investigator: tarek el husseiny, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 30, 2020

Primary Completion (ACTUAL)

February 1, 2021

Study Completion (ACTUAL)

March 1, 2021

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (ACTUAL)

April 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • misoprostol 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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