Trans Caesarean Intra Uterine Contraceptive Device Insertion Versus Conventional Postpartum 6 Weeks Insertion
IUDinsertion
1 other identifier
interventional
20
1 country
1
Brief Summary
To compare immediate post-placental intrauterine contraceptive device insertion versus conventional placement at 6 weeks interval (often referred to as delayed or interval insertion) as regard to:-
- 1.Patient satisfaction.
- 2.Expulsion rate.
- 3.Complications
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedFirst Posted
Study publicly available on registry
September 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedSeptember 5, 2023
September 1, 2023
12 months
August 6, 2023
September 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
1-Patient satisfaction and complication.
assessment of patient satisfaction using a questionnaire as follow: * Will you use the same method of contraception after the next delivery? * Will you recommend the same method to your fellows? * Are you happy or not with this procedure? give score from 1 to 10, 1 mean you are very unhappy while 10 mean you are very happy. * have you developed any complication?
6 months
Study Arms (2)
PPIUD
ACTIVE COMPARATORtrans cesarean IUD insertion immediately post placental
interval
ACTIVE COMPARATORIUD insertion 6 weeks interval post-partum
Interventions
Trans Caesarean Intra Uterine Contraceptive Device Insertion and Conventional Postpartum 6 Weeks Insertion
Eligibility Criteria
You may qualify if:
- Age: 18-40years.
- Full term pregnancies delivered by cesarean section.
- Desire to have intrauterine contraceptive device (Cu T) as a contraceptive option.
- Agree to participate in the study.
You may not qualify if:
- Allergy to copper.
- Ante- or intra-partum hemorrhage.
- Ruptured of membranes for more than 18 h prior to delivery or Chorioamnionitis.
- Known uterine abnormalities e.g., Bicornuate/septate Uterus, uterine myoma.
- History of ectopic pregnancy.
- Desire for pregnancy within 1 year of delivery.
- Intrapartum fever \>38 c.
- Sever thrombocytopenia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicin
Asyut, Egypt
Related Publications (1)
Hem E, Bordahl PE. Max Sanger - father of the modern caesarean section. Gynecol Obstet Invest. 2003;55(3):127-9. doi: 10.1159/000071524.
PMID: 12865589BACKGROUND
Central Study Contacts
Selim Ahmed, Assistant Professor
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
August 6, 2023
First Posted
September 5, 2023
Study Start
September 1, 2023
Primary Completion
August 30, 2024
Study Completion
September 1, 2024
Last Updated
September 5, 2023
Record last verified: 2023-09