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Comparison Between Intrauterine Contraceptive Device Insertion During Cesarean Section Vs Conventional Application

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ClinicalTrials.gov Identifier: NCT02674139
Recruitment Status : Unknown
Verified September 2016 by sara AbdAllah, Beni-Suef University.
Recruitment status was:  Enrolling by invitation
First Posted : February 4, 2016
Last Update Posted : September 27, 2016
Sponsor:
Collaborator:
Beni-Suef University
Information provided by (Responsible Party):
sara AbdAllah, Beni-Suef University

Brief Summary:
The study aims to compare immediate post-placental (within 10 minutes of placenta delivery) intrauterine contraceptive device (Copper T 380A) insertion versus conventional placement at 6 weeks (often referred to as delayed or interval insertion) regarding the clinical outcomes (safety, efficacy, expulsion and continuation rates) for women undergoing caesarean section.

Condition or disease Intervention/treatment Phase
Contraception Device: Copper T 380A IUD Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Intrauterine Contraceptive Device Insertion During Caesarean Section Versus Conventional Application
Study Start Date : February 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: IUD insertion 6 Weeks after delivery
Subjects randomized to interval placement will have their Copper T 380A IUD placed in the office at six weeks postpartum or later
Device: Copper T 380A IUD
intrauterine contraceptive device T-shaped loaded with cupper
Other Name: Pregna

Experimental: Immediate Post-placental insertion
Subjects randomized to receive the Copper T 380A IUD within 10 minutes of delivery of the placenta during caesarean section.
Device: Copper T 380A IUD
intrauterine contraceptive device T-shaped loaded with cupper
Other Name: Pregna




Primary Outcome Measures :
  1. Expulsion: Complete IUD expulsion will be verified clinically and by transvaginal ultrasound [ Time Frame: 6 months ]
    Complete IUD expulsion will be verified clinically and by transvaginal ultrasound. An IUD will be considered to be partially expelled if a distance greater than 10 mm is measured between the vertical arm of the IUD and the junction between the endometrium and the uterine cavity)


Secondary Outcome Measures :
  1. Uterine perforation (assessed by pelvic ultrasonography or X-ray) [ Time Frame: 6 months ]
    To be assessed by pelvic ultrasonography or X-ray pelvis will to note for misplaced IUD

  2. Pelvic pain (using the 0-10 Numeric Pain Rating Scale) [ Time Frame: 6 months ]
    Using the 0-10 Numeric Pain Rating Scale and analgesic doses required

  3. Strings not visible (assessed by speculum examination) [ Time Frame: 6 months ]
    To be assessed by speculum examination.

  4. Pelvic infection: number of participants with Pelvic infection [ Time Frame: 6 months ]
    number of participants with Pelvic infection

  5. Psychological (satisfied or not) using questionnaire [ Time Frame: 6 months ]
    using questionnaire

  6. Pregnancy (assessed by serum pregnancy test and pelvic ultrasound) [ Time Frame: 6 months ]
    To be assessed by serum pregnancy test and pelvic ultrasound in suspicious cases (missed period - misplaced IUD - expelled IUCD either partial or complete)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Age: 18 - 45 years.
  • GA 36-40 weeks based upon the date of last normal menstruation, confirmed by ultrasonographic scan.
  • Desire to have intrauterine contraceptive device (Cu T) after counseling about different contraceptive options and consented to the study.

Exclusion criteria:

  • Allergy to copper.
  • Ante- or intra-partum hemorrhage.
  • Hemorrhagic disorders.
  • Current or past history of pelvic inflammatory disease.
  • Women known to have pelvic TB.
  • Known to have ruptured membranes for more than 24 h prior to delivery.
  • History of chorioamnionitis.
  • Known uterine abnormalities e.g., Bicornuate/septate Uterus, uterine myoma.
  • Patients presented with febrile morbidity prior to the operation defined as temperature above 38'c.
  • Multiple pregnancies.
  • Placenta previa.
  • History of ectopic pregnancy.
  • Anemia (hemoglobin <10 g/dl).
  • Cervical cancer or carcinoma in situ.
  • Diagnosis of active cervical infection for standard insertion.

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): NCT02674139


Sponsors and Collaborators
sara AbdAllah
Beni-Suef University
Investigators
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Principal Investigator: sara AA mohamed, master

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Responsible Party: sara AbdAllah, Assistant lecturer of Obstetrics and Gynecology Faculty of Medicine- Beni-sueif University, Beni-Suef University
ClinicalTrials.gov Identifier: NCT02674139     History of Changes
Other Study ID Numbers: GO-MD-IUD
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by sara AbdAllah, Beni-Suef University:
post placental-caesarean-IUD
Additional relevant MeSH terms:
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Copper
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances