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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-25

Study Completion Date

2022-03-01

Brief Summary

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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,

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Detailed Description

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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

Conditions

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to Study the Estimate Difficulty of Insertion Mirena IUD With Use of Prostaglandins

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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prostaglandins before iud insertion group

this group will receive 200 mcg prostaglandins in form of misoprostol 2 hrs before mirena iud insertion

Misoprostol

Intervention Type DRUG

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

No interventions assigned to this group

Interventions

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Misoprostol

misoprostol 200 mcg will be given sublingual 2 hrs before mirena iud insertion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes