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

NCT04178031 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-08-05

No results posted yet for this study

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 The woman can expect to feel cramping as the sound is inserted and withdrawn.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

Interventions

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed maged · professor

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2021-08-11
Completion
2021-08-11

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04178031 on ClinicalTrials.gov