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PostPlacental IUD Insertion

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: NCT02679820
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt

Brief Summary:
The immediate post cesarean section IUD insertion is a further step towards spreading more compliance to females in developing countries, with rapid increase in population size

Condition or disease Intervention/treatment Phase
Contraception Device: Copper T intrauterine device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: PostPlacental IUD insertion
Copper T intrauterine device will be inserted immediately following delivery of the placenta in cases of cesarean section deliveries.
Device: Copper T intrauterine device
Other Name: copper T IUD

No Intervention: Control
IUD will be offered as a method of contraception after puerperium



Primary Outcome Measures :
  1. Expulsion rate [ Time Frame: 6 months ]
  2. The percentage of females seeking contraception [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females desiring contraception by using intrauterine device following their vaginal delivery or cesarean section

Exclusion Criteria:

  • refusal to participate in the study
  • desiring other methods of contraception
  • will not use any method of contraception
  • has a contraindication for the use of IUD as bicornuate or septate uterus, sub mucous myomas, etc.

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): NCT02679820


Locations
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Egypt
Kasr el aini hospital
Cairo, Egypt, 12211
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
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Principal Investigator: Dina MR Dakhly, MD Cairo University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dina Mohamed Refaat Dakhly, Lecturer of Obstetrics and Gynecology, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT02679820    
Other Study ID Numbers: LA010516
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Copper
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs