Insertion of Copper T380 Versus Multiload IUD Post Partum

Not Applicable

• Conditions: IUD
• Interventions: Device: IUD

• Registration Number: NCT05283798
• Lead Sponsor: Mahmoud Abdelhameed Hussien Soliman

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2022-03-08
• Last Update Submitted: 2022-03-08
• Study First Posted: 2022-03-17
• Last Update Posted: 2022-03-17
• Study Start: 2022-08
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
number of bleeding days in first 6 weeks	IUD	compare numbers of bleeding days in first 6 weeks and first 6 month
rate of missed threads in the first 6 weeks	IUD	To compare efficacy safety \& side effects of multiload 375 IUD versus copper T 380 IUD when inserted during elective CS

Primary Outcome Measures

Name	Time	Method
expulsion rate after 6 weeks of insertion	6 weeks	compare expulsion rates between the two types after 6 weeks by ultrasoud

Secondary Outcome Measures

Name	Time	Method
compare bleedind dayes and shift to anthor methoud	6 weeks	1. - number of bleeding days in the 1st 6 weeks; 2. - number of bleeding days in each month in the 1st 6 months; 3. compare by US between the 2 types; 4. - the shift into another method and what is it