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Clinical and Ultrasonographic Predictors of IUD Related Complications

NCT06806358 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-03-18

No results posted yet for this study

Summary

* All patients fulfilling the selection criteria undergo complete clinical examination and detailed medical history obtained. Each patient had a Case Record Form (CRF) recording participants' name. number, previous deliveries and abortions, age, height, weight, BMI, LMP, past medical and surgical history and contraceptive history.
* All participants will be subjected to transvaginal ultrasound to measure uterine size, endometrial and myometrial thickness, uterine position, cervical length, cervical diameter and for detection of any contraindications for IUD insertion.

Power Doppler Energy (PDE) measurement for subendometrial microvascularization will be done and categorized as women with minor subendometrial vascularization (Classifications I and II) and major subendometrial vascularization (Classifications III, IV and V)

Conditions

  • IUCD Complication

Interventions

DEVICE

IUD insertion

* Perform a bimanual examination * Insert a warm, moistened speculum. * Cleanse the cervix with an antiseptic solution. * Open the sterile insertion instruments without touching * Remove the tenaculum by its handle and grasp the anterior or posterior lip of the cervix. * Apply gentle traction with the tenaculum to straighten the canal. * Remove the sound by its handle and gently insert it to measure the depth of the uterus. Do not apply great force if there is resistance. Apply further traction to the tenaculum and attempt to re-insert the sound at a different angle. Once the sound is inserted and removed * Open the IUD pack without touching its contents. * Put on sterile gloves. * Load the IUD and insert it into the uterine cavity according to the manufacturer instructions. * Gently remove the tenaculum. * Trim the strings of the IUD to 3-4 cm in length * Remove the speculum and assess the woman.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Maged · Cairo University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06806358 on ClinicalTrials.gov