Insertion of Copper T380 Versus Multiload IUD Post Partum

NCT ID: NCT05283798

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2023-12-31

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

Conditions

IUD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rate of missed threads in the first 6 weeks

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

Group Type: EXPERIMENTAL

IUD

Intervention Type: DEVICE

Postpartum intra-caesarean section insertion of copper T380 versus multiload 375

number of bleeding days in first 6 weeks

compare numbers of bleeding days in first 6 weeks and first 6 month

Group Type: OTHER

IUD

Intervention Type: DEVICE

Postpartum intra-caesarean section insertion of copper T380 versus multiload 375

Interventions

IUD

Postpartum intra-caesarean section insertion of copper T380 versus multiload 375

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mahmoud Abdelhameed Hussien Soliman

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Abdelhameed Hussien Soliman

resident

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Mahmoud Abdelhameed

Role: CONTACT

m7moud3bdel7ameed@gmail.com

01096128561

Other Identifiers

intra cs IUD

Identifier Type: -

Identifier Source: org_study_id