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Insertion of Copper T380 Versus Multiload IUD Post Partum

M

Mahmoud Abdelhameed Hussien Soliman

Status

Unknown

Conditions

IUD

Treatments

Device: IUD

Study type

Interventional

Funder types

Other

Identifiers

NCT05283798
intra cs IUD

Details and patient eligibility

About

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

Full 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

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

300 participants in 2 patient groups

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

Trial contacts and locations

0

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Central trial contact

Mahmoud Abdelhameed

Data sourced from clinicaltrials.gov

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