Clinical trial NCT05986344: Uterine Artery Doppler and Menstrual Changes After Insertion Intrauterine Contraceptive Device
Official title: Correlation Between Uterine Artery Doppler Indices and Menstrual Changes After Insertion of Copper Intrauterine Contraceptive Device and Levonorgestrel Intrauterine System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intrauterine Contraceptive Device Complication
Keywords: Intrauterine Contraceptive Device
Doppler
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 165
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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 .

Eligibility criteria: 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

Primary outcomes:
measure: menstrual changes.
timeFrame: 3 months after insertion
measure: uterine artery pulsatility index
timeFrame: 3 months after insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university Hospital
state: Beni Suef
Study officials:
affiliation: Faculty of Medicine Beni-Suef University
name: Beni-Suef University
role: PRINCIPAL_INVESTIGATOR
References: