Intra-cesarean Post Placental Introducer Withdrawal IUD Insertion Technique

Not Applicable

Completed

• Conditions: Intrauterine Contraceptive Device Complication
• Interventions: Procedure: IUD insertion during cesarean section

• Registration Number: NCT05788354
• Lead Sponsor: Cairo University

Brief Summary

This is a prospective randomized controlled study that was conducted to compare between the conventional (manual) technique of post placental IUD insertion and a new technique (intra-cesarean post placental introducer withdrawal IUD insertion technique) for IUD insertion during cesarean section regarding side effects and complications.

Detailed Description

Complete history taking and clinical examination were obtained from all cases. Lower segment cesarean section though Pfannenstiel incision was performed. Copper T380 IUDs were inserted to all participants during cesarean section after delivery of the placenta using the following techniques:

Group A (control group): (n = 420) First, the investigators Performed time out and verify that there were no contraindications to IUD placement:, Second, after package opening the investigators Removed the IUD from the introducer and trimmed IUD threads to 12 cm, Third, the investigators Grasped the IUD firmly along the stem of the device, Fourth the investigators Stabilized the uterus using the non-dominant hand or with the aid of an assistant and advanced the IUD through the hysterotomy to the fundus, Fifth, the investigators Removed hand and directed the IUD threads into the cervix and finally the investigators Closed the uterine incision, took care not to incorporate the IUD strings.

Group B (study group): (n = 420) First the investigators Performed time out and verified that there were no contraindications to IUD placement, Second, after package opening the investigators Removed IUD from the introducer and trimmed the IUD threads to 12 cm and also trimmed the introducer to 12 cm, Third, the investigators Loaded the IUD again inside the introducer (through the trimmed end) and kept the arms of the IUD unfolded, Forth, the investigators removed the shoulders of the introducer, Fifth, the investigators held the uterus and stabilized it by the non-dominant hand and guided the introducer containing the IUD strings first through the cervix then the investigators advanced the introducer with the IUD arms unfolded to the fundus and kept the IUD their by pressing on the fundus, then the investigators pushed the introducer gently through the cervix to the vagina, Finally, the investigators Closed the uterine incision, took care not to incorporate the introducer or the threads and then the investigators removed the introducer gently manually from the vagina after closure of the skin and ceiling of the wound.

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-09-01
• Study Completion: 2022-04-22
• Status Verified: 2023-03
• Study First Submitted: 2023-03-12
• Study First Submitted QC: 2023-03-25
• Last Update Submitted: 2023-03-25
• Study First Posted: 2023-03-28
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 788

Inclusion Criteria

• Pregnant women attending for elective or emergency cesarean section

Exclusion Criteria

• upper segment cesarean scar
• cesarean for placenta previa or placenta accrete
• evident infections
• uterine anomalies
• uterine myomas
• bleeding tendency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional method	IUD insertion during cesarean section	IFirst, we Performed time out and verify that there were no contraindications to IUD placement:, Second, after package opening we Removed the IUD from the introducer and trimmed IUD threads to 12 cm, Third, we Grasped the IUD firmly along the stem of the device, Fourth we Stabilized the uterus using the non-dominant hand or with the aid of an assistant and advanced the IUD through the hysterotomy to the fundus, Fifth, we Removed hand and directed the IUD threads into the cervix and finally we Closed the uterine incision, took care not to incorporate the IUD strings.
new method	IUD insertion during cesarean section	First we Performed time out and verified that there were no contraindications to IUD placement, Second, after package opening we Removed IUD from the introducer and trimmed the IUD threads to 12 cm and also trimmed the introducer to 12 cm, Third, we Loaded the IUD again inside the introducer (through the trimmed end) and kept the arms of the IUD unfolded, Forth, we removed the shoulders of the introducer, Fifth, we held the uterus and stabilized it by the non-dominant hand and guided the introducer containing the IUD strings first through the cervix then we advanced the introducer with the IUD arms unfolded to the fundus and kept the IUD their by pressing on the fundus, then we pushed the introducer gently through the cervix to the vagina, Finally, we Closed the uterine incision, took care not to incorporate the introducer or the threads and then we removed the introducer gently manually from the vagina after closure of the skin and ceiling of the wound.

Primary Outcome Measures

Name	Time	Method
Intrauterine displacement of the IUD	6 months	transvaginal ultrasound : the distance from the top of the uterine cavity to the IUD which should be \< 3 mm

Secondary Outcome Measures

Name	Time	Method
Missed or non-visualization of IUD threads	6 months	vaginal speculum examination: Missed or non-visualization of IUD threads by vaginal speculum examination
Discontinuation of the method	6 months	questionnaire
duration of surgery	6 months	time of surgery in minutes

Trial Locations

Locations (2)

Cairo Univesity; 🇪🇬 Cairo, Egypt

Cairo University; 🇪🇬 Cairo, Egypt