Intra-cesarean Post Placental Introducer Withdrawal IUD Insertion Technique

NCT05788354 | Completed

• 1 other identifier: I20015
• Study Type: interventional
• Target: 788
• Locations: 1 country
• Sites: 2

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.

Conditions

Intrauterine Contraceptive Device Complication

Outcome Measures

Primary Outcomes (1)

• Intrauterine displacement of the IUD

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

  6 months

Secondary Outcomes (3)

• Missed or non-visualization of IUD threads

  6 months

• Discontinuation of the method

  6 months

• duration of surgery

  6 months

Study Arms (2)

conventional method

ACTIVE COMPARATOR

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.

Procedure: IUD insertion during cesarean section

new method

EXPERIMENTAL

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.

Procedure: IUD insertion during cesarean section

Interventions

IUD insertion during cesarean section PROCEDURE

placement of IUD during cesarean section after placental delivery

conventional method; new method

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women attending for elective or emergency cesarean section

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Cairo University

Cairo, 2315, Egypt

Location

Cairo Univesity

Cairo, Egypt

Location

Related Publications (2)

• Elsokary A, Elkhyat A, Elshwaikh S. Evaluation of Post-Placental IUD Insertion during Cesarean Section at a Tertiary Care Hospital in Egypt. Open Journal of Obstetrics and Gynecology 2020;10:516-25. https://doi.org/10.4236/ojog.2020.1040046.

  BACKGROUND

• Seleem M, Sedik MM, Megahed AMM, Nabil H. Conventional manual technique of post placental IUD insertion versus intra-cesarean post placental introducer withdrawal IUD insertion technique: a new standardized technique for IUD insertion during cesarean section: a randomized controlled trial. BMC Pregnancy Childbirth. 2023 Jun 26;23(1):474. doi: 10.1186/s12884-023-05777-1.

  PMID: 37365489 DERIVED

Study Officials

• mostafa AH seleem, MD

  professor of ob&gyn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of 0b&gyn

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: March 28, 2023
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: April 22, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: beginning 1 month after publication for 5 years
• Access Criteria: through direct email with the principle investigator email: mostafasaleem@kasralainy.edu.eg

Locations

EG (2)