Post-placental Intrauterine Device Insertion During Cesarean Section

Intrauterine Device Migration Clinical Trial

Official title:

Hang-up Versus Non-fixation Technique for Immediate Post-placental Intrauterine Device Insertion During Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780985
• Other study ID #: IUD-Zahraa
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: September 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: April 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intrauterine Device Migration

Intervention

Procedure:
• Intrauterine device insertion
Post-placental insertion of intrauterine device during Cesarean section
• Cesarean section
to delivery of the fetus
• Suture
to fix the intrauterine device

Locations

Country	Name	City	State
Egypt	Woman's Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of displaced intrauterine device after insertion in both groups		2 weeks