Association Between Clinical, Laboratory, Ultrasongraphy Predictors And Development of Copper IUD Complications

Intrauterine Device Migration Clinical Trial

Official title:

Association Between Clinical,Laboratory,Ultrasongraphy Predictors And Development of Copper IUD Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178031
• Other study ID #: 172
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: August 11, 2021

Study information

• Verified date: August 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Only clinicians with proven proficiency in IUD insertion will be allowed to perform insertions . The steps of the IUD insertion procedure will be explained to the woman.

Perform a bimanual examination to determine the size, shape, and position of the uterus.

Insert a warm, moistened speculum. Cleanse the cervix with an antiseptic solution using 3 scoppettes or more (one for each sweep of the cervix).

Open the sterile insertion instruments without touching the inside of the packet and place within easy reach.

Remove the tenaculum by its handle and grasp the anterior or posterior lip of the cervix. Close gently to the first notch. Having the woman to cough while the tenaculum is being attached can ease the pinch.

Apply gentle traction with the tenaculum to straighten the canal. Remove the sound by its handle and gently insert 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, note the depth of the uterine cavity. The woman can expect to feel cramping as the sound is inserted and withdrawn.

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. As the IUD is inserted through the cervix into the uterus, the patient may have pain and cramping similar to strong menstrual cramps.

Gently remove the tenaculum. Tamponade any bleeding from the tenaculum site until it is resolved.

Trim the strings of the IUD to 3-4 cm in length and note the string length. Avoid cutting the strings too short. If the client or her partner becomes aware of the threads, they may be cut shorter in length at the follow-up visit.

Remove the speculum and assess the woman.

Description:

Only clinicians with proven proficiency in IUD insertion will be allowed to perform insertions . The steps of the IUD insertion procedure will be explained to the woman.

Perform a bimanual examination to determine the size, shape, and position of the uterus.

Insert a warm, moistened speculum. Cleanse the cervix with an antiseptic solution using 3 scoppettes or more (one for each sweep of the cervix).

Open the sterile insertion instruments without touching the inside of the packet and place within easy reach.

Remove the tenaculum by its handle and grasp the anterior or posterior lip of the cervix. Close gently to the first notch. Having the woman to cough while the tenaculum is being attached can ease the pinch.

Apply gentle traction with the tenaculum to straighten the canal. Remove the sound by its handle and gently insert 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, note the depth of the uterine cavity. The woman can expect to feel cramping as the sound is inserted and withdrawn.

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. As the IUD is inserted through the cervix into the uterus, the patient may have pain and cramping similar to strong menstrual cramps.

Gently remove the tenaculum. Tamponade any bleeding from the tenaculum site until it is resolved.

Trim the strings of the IUD to 3-4 cm in length and note the string length. Avoid cutting the strings too short. If the client or her partner becomes aware of the threads, they may be cut shorter in length at the follow-up visit.

Remove the speculum and assess the woman.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 11, 2021
• Est. primary completion date: August 11, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• 1. Multiparous women from 20 - 40 years of age , seeking contraception and choosing IUD as their preferred method after proper and thorough counseling.

2. Regularly menstruating women ( menstural cycle varying between 24- 38 days).

3. Contraceptive pills or any type of hormonal medication had not been taken for at least 3 months prior to the study, and any IUD had necessarily been removed at least 3 months earlier.

Exclusion Criteria:

• • Pregnancy or suspicion of pregnancy

• Congenital or acquired uterine anomalies which distort the uterine cavity (fibroids, endometrial polyps, cervical stenosis, bicornuate uterus, small 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, progesterone)

• Less than 4 weeks postpartum.

Related Conditions & MeSH terms

• Intrauterine Device Migration

Intervention

Device:
• IUD insertion
Insert a warm, moistened speculum. Cleanse the cervix with an antiseptic solution. Apply gentle traction with the tenaculum to straighten the canal. Remove the sound by its handle and gently insert 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, note the depth of the uterine cavity. The woman can expect to feel cramping as the sound is inserted and withdrawn. Load the IUD and insert it into the uterine cavity according to the manufacturer instructions. As the IUD is inserted through the cervix into the uterus, the patient may have pain and cramping similar to strong menstrual cramps. Gently remove the tenaculum. Trim the strings of the IUD to 3-4 cm in length Remove the speculum and assess the woman.

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	menorrhagia	occurrence of heavy menstrual flow	6 months after IUD insertion