Insertion of Copper T380 Versus Multiload IUD Post Partum

Sponsor

Mahmoud Abdelhameed Hussien Soliman (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05283798

Collaborator

(none)

300

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
IUD	Device: IUD	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: IUD Postpartum intra-caesarean section insertion of copper T380 versus multiload 375
Other: number of bleeding days in first 6 weeks compare numbers of bleeding days in first 6 weeks and first 6 month	Device: IUD Postpartum intra-caesarean section insertion of copper T380 versus multiload 375

Arm

Intervention/Treatment

Experimental: 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

Device: IUD

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

Other: number of bleeding days in first 6 weeks

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

Device: IUD

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

Outcome Measures

Primary Outcome Measures

expulsion rate after 6 weeks of insertion [6 weeks]
compare expulsion rates between the two types after 6 weeks by ultrasoud

Secondary Outcome Measures

compare bleedind dayes and shift to anthor methoud [6 weeks]
- 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mahmoud Abdelhameed Hussien Soliman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mahmoud Abdelhameed Hussien Soliman, resident, Assiut University

ClinicalTrials.gov Identifier:

NCT05283798

Other Study ID Numbers:

intra cs IUD

First Posted:

Mar 17, 2022

Last Update Posted:

Mar 17, 2022

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 17, 2022