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

• ClinicalTrials.gov Identifier: NCT05788354
• Recruitment Status: Completed
• First Posted: March 28, 2023
• Last Update Posted: March 28, 2023
• Sponsor: Cairo University
• Information provided by (Responsible Party): mostafa abdel hamid seleem, Cairo University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Intrauterine Contraceptive Device Complication	Procedure: IUD insertion during cesarean section	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 788 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Intra-cesarean Post Placental Introducer Withdrawal IUD Insertion Technique: A New Standardized Technique for IUD Insertion During Cesarean Section. A Randomized Controlled Trial
• Actual Study Start Date: September 1, 2020
• Actual Primary Completion Date: September 1, 2021
• Actual Study Completion Date: April 22, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Egypt

Cairo University

Cairo, Egypt, 2315

Cairo Univesity

Cairo, Egypt

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: mostafa AH seleem, MD; professor of ob&gyn

More Information

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.

• Responsible Party: mostafa abdel hamid seleem, professor of 0b&gyn, Cairo University
• ClinicalTrials.gov Identifier: NCT05788354
• Other Study ID Numbers: I20015
• First Posted: March 28, 2023
• Last Update Posted: March 28, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: all the participants data collected during the study after de-identification will be available
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No