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Insertion of Copper T380 Versus Multiload IUD Post Partum

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05283798
Enrollment
300
Registered
2022-03-17
Start date
2022-08-31
Completion date
2023-12-31
Last updated
2022-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IUD

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

Interventions

DEVICEIUD

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

Sponsors

Mahmoud Abdelhameed Hussien Soliman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
expulsion rate after 6 weeks of insertion6 weekscompare expulsion rates between the two types after 6 weeks by ultrasoud

Secondary

MeasureTime frameDescription
compare bleedind dayes and shift to anthor methoud6 weeks1. \- 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

Contacts

Primary ContactMahmoud Abdelhameed
m7moud3bdel7ameed@gmail.com01096128561

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026