Intra-cesarean Post Placental Introducer Withdrawal IUD Insertion Technique (IUD)

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

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.

Study Overview

• Status: Completed
• Conditions: Intrauterine Contraceptive Device Complication
• Intervention / Treatment: Procedure: IUD insertion during cesarean section

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 Type: Interventional
• Enrollment (Actual): 788
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 2315
    • Cairo University
  • Cairo, Egypt
    • Cairo Univesity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional method; 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; placement of IUD during cesarean section after placental delivery
Experimental: new method; 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; placement of IUD during cesarean section after placental delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: mostafa AH seleem, MD, professor of ob&gyn

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): April 22, 2022

Study Registration Dates

• First Submitted: March 12, 2023
• First Submitted That Met QC Criteria: March 25, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: I20015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all the participants data collected during the study after de-identification will be available
• IPD Sharing Time Frame: beginning 1 month after publication for 5 years
• IPD Sharing Access Criteria: through direct email with the principle investigator email: mostafasaleem@kasralainy.edu.eg
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No