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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: IUD
• Intervention / Treatment: Device: IUD

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud Abdelhameed; Phone Number: 01096128561; Email: m7moud3bdel7ameed@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
expulsion rate after 6 weeks of insertion	compare expulsion rates between the two types after 6 weeks by ultrasoud	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mahmoud Abdelhameed Hussien Soliman

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: intra cs IUD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No