to Study the Estimate Difficulty of Insertion Mirena IUD With Use of Prostaglandins
Conditions
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,
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
Interventions
DRUGMisoprostol
misoprostol 200 mcg will be given sublingual 2 hrs before mirena iud insertion
Sponsors
Cairo University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| cervical dilataion < 4 mm | During the intervention | need for cervical dilatation to pass the IUD |
| Pain at insertion according to VAS | During the intervention | By using the visual analogue score |
| side effects during IUD insertion: bleeding, vasovagal reaction, cramps, nausea, perforation, vomiting | During the intervention | Bleeding by using the soaked bads |
| Subjective sensation of satisfaction graduated as VAS like scale | During the intervention | By using the visual analogue score like system |
| side effects after 30 days of IUD insertion: spotting, cramps, acute PID and expulsion | After 30 days of intervention | — |
| Duration of insertion(min) | During the intervention | From start of procedure till removing the speculum |
| side effects after 24 hrs of IUD insertion: nausea, vomiting, cramps and hyperthermia | During the first 24 hours | — |
Countries
Egypt
Contacts
Primary Contacthany saad, assisstant prof
Backup Contacthadeer meshaal, assistant prof
Outcome results
None listed