Post-placental Intrauterine Device Insertion During Cesarean Section

Not Applicable

Completed

• Conditions: Intrauterine Device Migration
• Interventions: Procedure: Intrauterine device insertion; Procedure: Cesarean section; Procedure: Suture

• Registration Number: NCT03780985
• Lead Sponsor: Assiut University

Brief Summary

Effective, reversible postpartum contraception decreases the chance of rapid repeat pregnancy and poor perinatal outcome in a subsequent pregnancy especially in women delivered by cesarean section.The traditional 6-week postpartum visits not evidenced based and may not meet patient needs, particularly with respect to provision of contraception.Intrauterine device placement after delivery of the placenta is an appealing strategy for increasing access to postpartum Intrauterine device because it does not require a separate postpartum visit.

Advantage of post-placental Intrauterine device insertion, Intrauterine devices are recommended as first-line contraceptives by the American Academy of Pediatricians. The Centers for Disease Control and Prevention united state . Medical Eligibility Criteria for Contraceptive Use places no restrictions on use, and states advantages generally outweigh the risks for immediate postpartum use of Intrauterine devices.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-19
• Study Start: 2019-01-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-04-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-09
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 118

Inclusion Criteria

1. Age group : 18-40 years
2. Women who will be willing to undergo elective cesarean section
3. women desire using Copper IUD as long acting contraceptive method.

Exclusion Criteria

1. Intrauterine infection.
2. Fundal Myoma.
3. Hemorrhagic disorder
4. Genital tract malignancy
5. Uterine atony
6. Sexually transmitted infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intrauterine device insertion with a suture fixation	Intrauterine device insertion	Intruterine device through hysterotomy incision during cesarean section with a suture fixation
intrauterine device insertion with a suture fixation	Suture	Intruterine device through hysterotomy incision during cesarean section with a suture fixation
intrauterine device insertion with a suture fixation	Cesarean section	Intruterine device through hysterotomy incision during cesarean section with a suture fixation
intrauterine device insertion without a suture fixation	Cesarean section	IUD through hysterotomy incision during cesarean section without a suture fixation
intrauterine device insertion without a suture fixation	Intrauterine device insertion	IUD through hysterotomy incision during cesarean section without a suture fixation

Primary Outcome Measures

Name	Time	Method
Number of displaced intrauterine device after insertion in both groups	2 weeks

Trial Locations

Locations (1)

Woman's Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt