New Method of IUD Insertion During Cesarian Section

February 23, 2023 updated by: Bassiony Dabian, Cairo University
In women undergoing elective CS, half of them will have Intra-caesarian copper T 380 IUD insertion using the standard method and the remaining half will undergo copper T 380 IUD insertion during CS using a new technique in order to detect which technique is more effective in having more accurate IUD position with visible threads.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Intrauterine device (IUD) is considered one of the most acceptable and effective contraceptive methods used. It is widely accepted and used in Egypt at a large scale than any other type of contraception with many advantages over the other types of contraceptive methods including long acting hormonal methods . Despite IUD complications, it remains the most accepted method, as it has many advantages like being non-coital related, had no systemic complications, of long duration and reversible with rapid return of fertility after its removal . The complications of IUD include heavy menstrual bleedings, menstrual irregularities and infection complications which could be minimized by using strict aseptic techniques during insertion . The most distressing complication is the displacement of IUD, especially if this displacement was extra-uterine, as the patient needs a surgical maneuver (endoscopic usually) for extraction of this IUD. Displacement of IUDs puts a financial and psychological burden to the patient also increases the risk of unwanted pregnancies and its related risks . Displacement of IUD occurs mainly during its insertion, and occurs mainly due to rough or wrong technique; also IUD insertion at a wrong timing may increase risk of IUD displacement. So it is very important to insert IUDs at the proper time with the proper technique . Timing of insertion of IUD after cesarean section is a matter of debate, some gynecologists insert IUDs during cesarean section after placental removal, while other gynecologists prefer insertion of IUDs after an interval either immediately after puerprium (42 days), or after 6 months post-cesarean section, but the majority inserts IUDs after 3 months from cesarean section . The idea of waiting a three-month interval after cesarean section is to assure that the scar had completely healed and the uterus involutes completely to its pre-pregnancy size. The drawbacks of waiting this long interval are poor accessibility of the cervix which may be pulled upward in some cases of repeated cesarean section and loss of self-enthusiasm for rapid contraception after delivery .

Study Type

Interventional

Enrollment (Anticipated)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Kasr Alainy outpatient infertility clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant , full term patients , scheduled for elective CS.

Exclusion Criteria:

  • contraindications for IUD insertion ( chorioamnionitis , congenital uterine malformations ) - Patient refusing IUD contraception.
  • Patients with intra-operative bleeding or vital instability.
  • Active genital infection at time of insertion.
  • Medical disorders e.g. : cardiac , bleeding disorders , T.B. .. etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: classic technique
Device: Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique)
During CS , placement of CuT380 IUD at the top of the uterine fundus with ring forceps or manually; before closing the uterine incision, the strings were placed in the lower uterine segment. If the cervix was closed, dilatation from above with ring forceps or manually. Strings passed through the cervix with ring forceps, then checking that IUD remains at the fundus of the uterus prior to closing the uterine incision. The surgeon took a good care not to include IUD strings within the sutures. Six weeks postpartum; Patients will be questioned for any symptoms of complications or side effects. Pelvic examination (per speculum) and transvaginal ultrasound will be performed. Patient satisfaction will be assessed: pain using (VAS score), missed threads.
Procedure: cesarian section
Under general or spinal anathesia , the abdomen is opened in layers , the bladder is dissected downwards . The uterus is incised at its lower segment & the fetus is extracted , followed by the placenta & membranes . The CU T 380 IUD is inserted either by the classic technique or the standard technique . The uterus is closed in 2 layers by continous non - locked sutures .Proper hemostasis & closure of the abdomen in layers .
Experimental: new technique
Procedure: cesarian section
Under general or spinal anathesia , the abdomen is opened in layers , the bladder is dissected downwards . The uterus is incised at its lower segment & the fetus is extracted , followed by the placenta & membranes . The CU T 380 IUD is inserted either by the classic technique or the standard technique . The uterus is closed in 2 layers by continous non - locked sutures .Proper hemostasis & closure of the abdomen in layers .
Device: Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique)
During CS, the plunger will be removed, the introducer remains in place and the arms of the IUD were released to be in a transverse position. The introducer will be inserted in the cervical canal through the uterine incision, threads might be shortened if needed or if couldn't be advanced into the cervical canal, The introducer containing the IUD will be then pushed upwards , towards the uterine fundus.The IUD will be placed at the uterine fundus and the IUD will be stabilized at its fundal position by grasping the fundus between the thumb anteriorly and the other fingers posteriorly. The uterine incision was closed while the introducer is in situ , then the introducer will be removed vaginally at the end of CS. Six weeks postpartum; Patients will be followed as in the classic technique group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of IUD position.
Time Frame: 3 months
using ultrasound the position of IUD by measuring the distance between the IUD & the fundus of the uterus.
3 months
visibility of the threads of IUD.
Time Frame: 3 months
using a cusco speculum , the IUD threads are inspected.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications of IUD
Time Frame: 1 month
complications as pain , vaginal bleeding , infection are followed using specific questionnaire filled by the patient
1 month
patient overall satisfaction about the new technique
Time Frame: 3 months
using specific questionnaire to be filled by the patient
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2022

Primary Completion (Anticipated)

February 28, 2023

Study Completion (Anticipated)

March 15, 2023

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Estimate)

March 7, 2023

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-673-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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