NCT06806358

Brief 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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

January 21, 2025

Last Update Submit

March 17, 2025

Conditions

IUCD Complication

Outcome Measures

Primary Outcomes (1)

  • Failed IUD insertion

    failure of IUD insertion

    9 months

Study Arms (1)

IUD insertion

EXPERIMENTAL

IUD insertion in women needing contraception

Device: IUD insertion

Interventions

IUD insertionDEVICE

* 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.

IUD insertion

Eligibility Criteria

Age20 Years - 41 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20 -41 years
  • BMI 18-25 kg/m2
  • Women with any parity seeking contraception and choosing IUD as their preferred method after proper and thorough counseling
  • Regularly menstruating women (duration of menstruation 3-7 days and length of cycle 22- 35 days).
  • Not using any hormonal therapy or anticoagulation

You may not qualify if:

  • Cervical abnormalities.
  • Pregnancy or suspicion of pregnancy
  • Congenital or acquired uterine anomalies which distort the uterine cavity (fibroids, endometrial polyps, cervical stenosis, bicornuate uterus, hypoplastic uterus \< 6 cm)
  • Acute PID or a history of PID within the past 3 months
  • Postpartum or post-abortion endometritis within the past 3 months
  • Current STI or within the past 3 months (including cervicitis)
  • Cervical cancer
  • Endometrial cancer
  • Malignant gestational trophoblastic disease
  • Undiagnosed vaginal bleeding
  • Hypersensitivity to any component in the IUD (copper)
  • Less than 6 weeks postpartum.
  • Neurological or psychological conditions that may affect pain sensation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

RECRUITING

Study Officials

  • Ahmed Maged

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged

CONTACT

+201005227404ahmedmaged@cu.edu.eg

Ahmed chamel

CONTACT

+20 110 066 2255ahmed-chamel@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: IUCD insertion
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 21, 2025

First Posted

February 4, 2025

Study Start

February 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations

EG(1)