Insertion of Copper T380 Versus Multiload IUD Post Partum

IUD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05283798
• Other study ID #: intra cs IUD
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: Mahmoud Abdelhameed
• Phone: 01096128561
• Email: m7moud3bdel7ameed[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• IUD

Intervention

Device:
• IUD
Postpartum intra-caesarean section insertion of copper T380 versus multiload 375

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahmoud Abdelhameed Hussien Soliman

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	expulsion rate after 6 weeks of insertion	compare expulsion rates between the two types after 6 weeks by ultrasoud	6 weeks
Secondary	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