Prostaglandins Use Before Mirena IUD Insertion in Prev CS Women During Lactational Amenorrhea

This is a prospective randomized controlled study to determine the effect of prostaglandin intake before Mirena IUD insertion It was conducted at the Department of Obstetrics & Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University,

Study Overview

• Status: Unknown
• Conditions: to Study the Estimate Difficulty of Insertion Mirena IUD With Use of Prostaglandins
• Intervention / Treatment: Drug: Misoprostol

Detailed Description

The study aiming to measure the estimate difficulty of insertion of the Mirena IUD by using prostaglandins 2 hours before the procedure and the effect of prostaglandins to make this procedure easy with other side effects and complications as bleeding perforation, nausea, vomiting, failure of insertion and comparing them with a placebo group who didn't receive prostaglandins

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: hany saad, assisstant prof; Phone Number: 01001817211; Email: hanysaad25280@gmail.com
• Study Contact Backup: Name: hadeer meshaal, assistant prof; Phone Number: 01001435238; Email: dr_hadeer@live.com

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Recruiting
    • Cairo University
    • Contact: hany saad, assistant prof; Phone Number: 01001817211; Email: hanysaad25280@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

female patients during the lactational amenorrhea who undergo Mirena IUD insertion after had been delivered by CS within 6 monthes

Description

Inclusion Criteria:

• 1- Women in lactational amenoeehea with pregnancy test negative 2- Women who had caesarean section within 6 monthes of IUD insertion 3- No medical disorders

Exclusion Criteria:

• 1- Women in regular menses 2- Medical disorders 3- Nulligravida or muligravida with NVD 4- Women with history of Previous CS more than one CS 5- Any congenital uterine anomalies, fibroids and adenomysis 6- Chronic pelvic pain 7- Intrauterine adhesions 8- Spasmodic dysmenohrrea 9- Allergy to misoprostol

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
prostaglandins before iud insertion group; this group will receive 200 mcg prostaglandins in form of misoprostol 2 hrs before mirena iud insertion	Drug: Misoprostol; misoprostol 200 mcg will be given sublingual 2 hrs before mirena iud insertion
placebo group; this group will receive placebo tablet before mirena iud insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulty of insertion of Mirena IUD by using the Ease of Insertion score graduated as VAS like scale	By using the visual analogue score	During the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cervical dilataion < 4 mm	need for cervical dilatation to pass the IUD	During the intervention
Pain at insertion according to VAS	By using the visual analogue score	During the intervention
Subjective sensation of satisfaction graduated as VAS like scale	By using the visual analogue score like system	During the intervention
side effects during IUD insertion: bleeding, vasovagal reaction, cramps, nausea, perforation, vomiting	Bleeding by using the soaked bads	During the intervention
side effects after 24 hrs of IUD insertion: nausea, vomiting, cramps and hyperthermia		During the first 24 hours
side effects after 30 days of IUD insertion: spotting, cramps, acute PID and expulsion		After 30 days of intervention
Duration of insertion(min)	From start of procedure till removing the speculum	During the intervention

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 25, 2020
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: November 7, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (ACTUAL): November 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Amenorrhea; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: professor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No