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Post-placental Intrauterine Device Insertion During Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780985
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Abdelrahman Mahmoud Mohammed, Assiut University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Intrauterine Device Migration Procedure: Intrauterine device insertion Procedure: Cesarean section Procedure: Suture Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hang-up Versus Non-fixation Technique for Immediate Post-placental Intrauterine Device Insertion During Cesarean Section
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : February 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
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
Post-placental insertion of intrauterine device during Cesarean section

Procedure: Cesarean section
to delivery of the fetus

Procedure: Suture
to fix the intrauterine device
Active Comparator: intrauterine device insertion without a suture fixation
IUD through hysterotomy incision during cesarean section without a suture fixation
 Procedure: Intrauterine device insertion
Post-placental insertion of intrauterine device during Cesarean section

Procedure: Cesarean section
to delivery of the fetus


Outcome Measures
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Primary Outcome Measures :
  1. Number of displaced intrauterine device after insertion in both groups [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780985


Locations
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Egypt
Woman's Health Hospital - Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Abdelrahman Mahmoud Mohammed, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03780985    
Other Study ID Numbers: IUD-Zahraa
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intrauterine Device Migration
Foreign-Body Migration
Foreign Bodies
Wounds and Injuries