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

• Sponsor: Cairo University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04646161
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 15.1
• Patients Per Site Per Month: 26.4

Study Details

Study Description

Brief Summary

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,

Condition or Disease	Intervention/Treatment	Phase
to Study the Estimate Difficulty of Insertion Mirena IUD With Use of Prostaglandins	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 400 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Prostaglandins Use Before Mirena IUD Insertion in Prev CS Women During Lactational Amenorrhea
• Actual Study Start Date: Nov 25, 2020
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Difficulty of insertion of Mirena IUD by using the Ease of Insertion score graduated as VAS like scale [During the intervention]

   By using the visual analogue score

Secondary Outcome Measures

1. cervical dilataion < 4 mm [During the intervention]

   need for cervical dilatation to pass the IUD

2. Pain at insertion according to VAS [During the intervention]

   By using the visual analogue score

3. Subjective sensation of satisfaction graduated as VAS like scale [During the intervention]

   By using the visual analogue score like system

4. side effects during IUD insertion: bleeding, vasovagal reaction, cramps, nausea, perforation, vomiting [During the intervention]

   Bleeding by using the soaked bads

5. side effects after 24 hrs of IUD insertion: nausea, vomiting, cramps and hyperthermia [During the first 24 hours]

6. side effects after 30 days of IUD insertion: spotting, cramps, acute PID and expulsion [After 30 days of intervention]

7. Duration of insertion(min) [During the intervention]

   From start of procedure till removing the speculum

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt	02

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hany saad, assisstant professor, Cairo University
• ClinicalTrials.gov Identifier: NCT04646161
• Other Study ID Numbers: professor
• First Posted: Nov 27, 2020
• Last Update Posted: Jan 19, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Amenorrhea; Misoprostol

Study Results

No Results Posted as of Jan 19, 2021