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

NCT ID: NCT04178031

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-02
• Study Completion Date: 2021-08-11

Brief 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 The woman can expect to feel cramping as the sound is inserted and withdrawn.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.

Detailed 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.

Conditions

Intrauterine Device Migration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

IUD insertion group

All participants will have IUD inserted and follow up for occurance of complications

Group Type: EXPERIMENTAL

IUD insertion

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed M Maged, MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed maged

Role: STUDY_DIRECTOR

professor

Locations

Kasr Alainy medical school

Cairo, , Egypt

Countries

Egypt

Other Identifiers

172

Identifier Type: -

Identifier Source: org_study_id