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Completed

NCT Number: NCT05788354

Intra-cesarean Post Placental Introducer Withdrawal IUD Insertion Technique

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University, Cairo, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IUD insertion during cesarean section

Procedure

placement of IUD during cesarean section after placental delivery

Primary outcomes

  1. Intrauterine displacement of the IUD

    Time frame: 6 months

    transvaginal ultrasound : the distance from the top of the uterine cavity to the IUD which should be < 3 mm

Secondary outcomes

  1. Missed or non-visualization of IUD threads

    Time frame: 6 months

    vaginal speculum examination: Missed or non-visualization of IUD threads by vaginal speculum examination

  2. Discontinuation of the method

    Time frame: 6 months

    questionnaire

  3. duration of surgery

    Time frame: 6 months

    time of surgery in minutes

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Intra-cesarean Post Placental Introducer Withdrawal IUD Insertion Technique: A New Standardized Technique for IUD Insertion During Cesarean Section. A Randomized Controlled Trial

Acronym: IUD

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 28, 2023
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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