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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04339348
Collaborator
(none)
210
1
3
10
21

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: vaginal misoprostol
  • Drug: Lidocaine-Prilocaine Topical cream
  • Drug: placebo
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Apr 30, 2020
Actual Primary Completion Date :
Feb 1, 2021
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. pain during LNG-IUD insertion [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

Secondary Outcome Measures

  1. duration of insertion [5 minutes]

    duration of LNG-IUD insertion from speculum in to speculum out

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ahmedsamy Giza Egypt 12511

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Samy aly ashour, assistant professor obstetrics and gynecology, Cairo University
ClinicalTrials.gov Identifier:
NCT04339348
Other Study ID Numbers:
  • misoprostol vs LP cream
First Posted:
Apr 9, 2020
Last Update Posted:
May 7, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 7, 2021