Post-placental Intrauterine Device Insertion During Cesarean Section

NCT03780985 | Completed

• 1 other identifier: IUD-Zahraa
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Device Migration

Outcome Measures

Primary Outcomes (1)

• Number of displaced intrauterine device after insertion in both groups

  2 weeks

Study Arms (2)

intrauterine device insertion with a suture fixation

ACTIVE COMPARATOR

Intruterine device through hysterotomy incision during cesarean section with a suture fixation

Procedure: Intrauterine device insertion; Procedure: Cesarean section; Procedure: Suture

intrauterine device insertion without a suture fixation

ACTIVE COMPARATOR

IUD through hysterotomy incision during cesarean section without a suture fixation

Procedure: Intrauterine device insertion; Procedure: Cesarean section

Interventions

Intrauterine device insertion PROCEDURE

Post-placental insertion of intrauterine device during Cesarean section

intrauterine device insertion with a suture fixation; intrauterine device insertion without a suture fixation

Cesarean section PROCEDURE

to delivery of the fetus

intrauterine device insertion with a suture fixation; intrauterine device insertion without a suture fixation

Suture PROCEDURE

to fix the intrauterine device

intrauterine device insertion with a suture fixation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Intrauterine infection.
• Fundal Myoma.
• Hemorrhagic disorder
• Genital tract malignancy
• Uterine atony
• Sexually transmitted infection.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Woman's Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Intrauterine Device Migration

Interventions

Cesarean Section; Sutures

Condition Hierarchy (Ancestors)

Foreign-Body Migration; Foreign Bodies; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 19, 2018
• Study Start: January 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: April 1, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

EG (1)