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

NCT04178031 | Completed DMC

• 1 other identifier: 172
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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 The woman can expect to feel cramping as the sound is inserted and withdrawn.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

Conditions

Intrauterine Device Migration

Outcome Measures

Primary Outcomes (1)

• menorrhagia

  occurrence of heavy menstrual flow

  6 months after IUD insertion

Study Arms (1)

IUD insertion group

EXPERIMENTAL

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

Device: IUD insertion

Interventions

IUD insertion 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.

IUD insertion group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Multiparous women from 20 - 40 years of age , seeking contraception and choosing IUD as their preferred method after proper and thorough counseling.
• \. Regularly menstruating women ( menstural cycle varying between 24- 38 days).
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

MeSH Terms

Conditions

Intrauterine Device Migration

Condition Hierarchy (Ancestors)

Foreign-Body Migration; Foreign Bodies; Wounds and Injuries

Study Officials

• Ahmed maged

  professor

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: November 26, 2019
• Study Start: December 2, 2019
• Primary Completion: August 11, 2021
• Study Completion: August 11, 2021
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)