Clinical trial NCT04178031: Association Between Clinical, Laboratory, Ultrasongraphy Predictors And Development of Copper IUD Complications
Official title: Association Between Clinical,Laboratory,Ultrasongraphy Predictors And Development of Copper IUD Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Device Migration
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 The woman can expect to feel cramping as the sound is inserted and withdrawn.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

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.

Primary outcomes:
measure: menorrhagia
timeFrame: 6 months after IUD insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: professor
name: Ahmed maged
role: STUDY_DIRECTOR
References: