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CompletedNCT03780985Updated Sep 16, 2021

Post-placental Intrauterine Device Insertion During Cesarean Section

An interventional study of Intrauterine device insertion and Cesarean section in Intrauterine Device Migration, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-16.

Sponsored by Assiut University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
118
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Intrauterine Device Migration
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  1. Intrauterine infection.
  2. Fundal Myoma.
  3. Hemorrhagic disorder
  4. Genital tract malignancy
  5. Uterine atony
  6. Sexually transmitted infection.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
118 participants (actual)

Study arms

  • Active comparator
    intrauterine device insertion with a suture fixation

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

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

  • Active comparator
    intrauterine device insertion without a suture fixation

    IUD through hysterotomy incision during cesarean section without a suture fixation

    Procedure: Intrauterine device insertion · Procedure: Cesarean section

Interventions

  • ProcedureIntrauterine device insertion

    Post-placental insertion of intrauterine device during Cesarean section

  • ProcedureCesarean section

    to delivery of the fetus

  • ProcedureSuture

    to fix the intrauterine device

06

What researchers measure

Primary outcomes

  1. Number of displaced intrauterine device after insertion in both groups

    Time frame: 2 weeks

07

Study locations

1 site
  • Woman's Health Hospital - Assiut university
    Assiut, 71111, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03780985
Lead sponsor
Assiut University
Responsible party
Abdelrahman Mahmoud Mohammed (Assistant Lecturer, Assiut University) — Principal investigator
First posted
Dec 19, 2018
Start date
Jan 1, 2019
Primary completion
Feb 1, 2020
Completion
Apr 1, 2020
Last update
Sep 16, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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