Postpartum Immediate Contraception in Cesarean Deliveries-Comparison of Two Intrauterine Systems

Study Overview
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Brief Summary
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To compare two intrauterine systems in order to avoid complications originating from short pregnancy interval and undesired pregnancies in the early postpartum period.

Detailed Description
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The patients admitting to Zeynep Kamil Research and Training Hospital for caesarean delivery will be included in the study. There will be two computer based randomized groups. The investigators expect that both groups will have 100 cases. First group will be treated with conventional intrauterine devices (Cu T380 A) while the second group will be treated with frameless intrauterine devices (GyneFix). The participants will be informed about postpartum unplanned pregnancies and the complications of short pregnancy interval. Participants will also be informed about possible complications of having an intrauterine device and that there may be a possibility of failure.The participants who choose to participate in the study will be divided into two groups by computer based randomization and one of the systems will be applied. After the participants read and sign the informed consent form, the intrauterine device will be applied postplacental up to 10 minutes.

Official Title
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Comparative of Two Devices (Conventional Intrauterine Devices (Cu T380 A)/Frameless Intrauterine Devices (GyneFix)) for Postpartum Immediate Contraception in Cesarean Deliveries

Conditions
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Intrauterine Systems, Postpartum Immediate Contraception

Intervention / Treatment
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* Device: GyneFix
* Device: Cu T380 A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients who read and sign the informed consent form. Exclusion Criteria: The patient who has more than 6 cm dilatation, prolonged premature rupture of the membranes (more than 12 hours), chorioamnionitis, and kongenital or acquired haemorragic diathesis will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gynefix<br>The GyneFix® 200 IUD(frameless iud) is only 2 cm long. Its small surface area is 1/3 of that of the conventional T-shaped IUDs such as TCu380A | Device: GyneFix<br>* The fiber is fixed to the anchoring thread by means of a stainless steel clip 1 cm from the upper part of the anchoring knot. The anchoring knot is implanted into the myometrium of the uterus thus permanently securing the implant in the uterine cavity<br>* Other names: Gynefix(frameless intrauterine devices);|
| Active Comparator: Cu T380a<br>conventional T-shaped IUDs (TCu380A)which has a frame will be placed into the uterus after placental extraction | Device: Cu T380 A<br>* Cu T380 A will be inserted into the uterus<br>* Other names: Copper T 380a;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expulsion rates | expulsion is the major obstacle for intrauterin devices when using immediate postpartum. | The patients will be seen postoperative 6th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by conventional intrauterine devices (Cu T380 A) and frameless intrauterine devices (GyneFix) | there are some effects due to intrauterin devices. we want to compare the differences between two devices | The patients will be seen postoperative 6th week |