Intrauterine Contraceptive Device Complication
Conditions
Keywords
Intrauterine Contraceptive Device, Doppler
Brief summary
To evaluate the correlation between uterine artery Doppler indices and subsequent menstrual changes after 3 months of insertion of copper T-380 IUD and LNG-IUS
Detailed description
A randomized prospective clinical trial Study Population: The study population includes multiparous women, having normal menstrual cycles, who are eligible for insertion of IUCD. Women will be recruited for enrollment when they come to the family planning clinic. They will be counseled about different contraceptive options. If they want to have the IUCD, they will be asked to participate in the study after been evaluated to ensure fulfilling inclusion and exclusion criteria Women will be enrolled in the study after giving written informed consent Group (A): ….Women will have the copper T-380 IUD (PREGNA, India, imported by DKT Egypt LLC-Egypt) ® IUD. Group (B): …. Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD .
Interventions
DEVICECopper intrauterine contraceptive device
copper T-380 IUD
DEVICELNG-IUS
Levonorgestrel Intrauterine System
Sponsors
Beni-Suef University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Desire to have intrauterine contraceptive device after counseling about different contraceptive options and consented to the study. * Normal menstrual bleeding cycles (24-35 days).
Exclusion criteria
1. Nulliparity. 2. Undiagnosed uterine bleeding. 3. Any proven ovarian, uterine or endometrial pathology such as; uterine myoma, adenomyosis, endometrial polyps, ovarian cysts 4. Contraceptive pills had not been taken during the previous 3 months and any previous IUD had been removed at least 1 month earlier 5. Hemorrhagic disorders. 6. Acute or chronic pelvic inflammatory disease 7. Known uterine anomalies e.g., Bicornuate/septate Uterus. 8. Anemia (hemoglobin \<10 g/dl). 9. Diagnosis of active cervical infection 10. Dysplasia in the cervix. 11. Patients wishing post-partum or post-abortum IUD insertion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| menstrual changes. | 3 months after insertion | Pictorial blood loss assessment chart PBAC score (a score \>100was equivalent to blood loss \>80 mL) |
| uterine artery pulsatility index | 3 months after insertion | trans-vaginal ultrasound pulsed doppler |
Countries
Egypt
Contacts
Primary ContactSara A Salem, MD
Outcome results
None listed