Insertion of Copper T380 Versus Multiload IUD Post Partum

Study Overview
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Brief Summary
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To compare efficacy safety & side effects of multiload 375 IUD versus copper T 380 IUD when inserted during elective CS

Detailed Description
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Insertion of an intrauterine device (IUD) immediately after delivery is appealing for several reasons. The woman is known not to be pregnant, her motivation for contraception may be high, and the setting may be convenient for both the woman and her provider The World Health Organization (WHO) recommends that a woman should wait at least 24 months after delivery before the next pregnancy to decrease the adverse maternal, perinatal ,and infant outcomes. Compared with other contraceptive methods, early post-partum IUD insertion has several advantages. It provides immediate contraception without interfering with breast feeding, and it may avoid discomfort related to insertion. Inserting an IUD immediately after placental removal has not been associated with increased infection, uterine perforation, postpartum bleeding, or uterine subinvolution . The expulsion rate is higher (approximately 12% in the first postpartum year) after immediate postpartum insertion compared to insertion 4 to 8 weeks later. Continuation rates are relatively high (87.6% and 76.3%, at 6 and 12 months, respectively Studies have shown that with effective provider training, the immediate postpartum IUD insertion (IPPIUD) complications such as expulsion, pelvic infection, bleeding, pain, missing threads ,and failure rates are not significantly different from those of interval PPIUD insertion (4:6 weeks) after delivery

Official Title
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Postpartum Intra-caesarean Section Insertion of Copper T380 Versus Multiload 375 IUD in a Randomized Controlled Trial.

Conditions
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IUD

Intervention / Treatment
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* Device: IUD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women delivered by elective CS ≥ 36 wks Exclusion Criteria: Patients with PROM Patients on corticosteroids therapy Patients on anticoagulant patients who refuse participate in the study with written consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rate of missed threads in the first 6 weeks<br>To compare efficacy safety & side effects of multiload 375 IUD versus copper T 380 IUD when inserted during elective CS | Device: IUD<br>* Postpartum intra-caesarean section insertion of copper T380 versus multiload 375<br>|
| Other: number of bleeding days in first 6 weeks<br>compare numbers of bleeding days in first 6 weeks and first 6 month | Device: IUD<br>* Postpartum intra-caesarean section insertion of copper T380 versus multiload 375<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expulsion rate after 6 weeks of insertion | compare expulsion rates between the two types after 6 weeks by ultrasoud | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare bleedind dayes and shift to anthor methoud | - number of bleeding days in the 1st 6 weeks - number of bleeding days in each month in the 1st 6 months compare by US between the 2 types - the shift into another method and what is it | 6 weeks |