New Method of IUD Insertion During Cesarian Section

Not Applicable

Recruiting

• Conditions: Postpartum Contraception
• Interventions: Device: Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique); Device: Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique); Procedure: cesarian section

• Registration Number: NCT05756998
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Study Start: 2022-02-02
• Study First Submitted: 2023-01-24
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-23
• Last Update Submitted: 2023-02-23
• Primary Completion: 2023-02-28
• Study First Posted: 2023-03-07
• Last Update Posted: 2023-03-07
• Study Completion: 2023-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
classic technique	cesarian section	-
classic technique	Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique)	-
new technique	cesarian section	-
new technique	Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique)	-

Primary Outcome Measures

Name	Time	Method
visibility of the threads of IUD.	3 months	using a cusco speculum , the IUD threads are inspected.
accuracy of IUD position.	3 months	using ultrasound the position of IUD by measuring the distance between the IUD \& the fundus of the uterus.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kasr Alainy outpatient infertility clinic; 🇪🇬 Cairo, Egypt