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出境医 / 临床实验 / IUD Insertion During Cesarean Section

IUD Insertion During Cesarean Section

Study Description
Brief Summary:
Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical Trial

Condition or disease Intervention/treatment Phase
Contraception Device: IUD during CS Device: IUD after puerperium Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Insertion of Intrauterine Contraceptive Device During Cesarean Section: Randomized Clinical Trial
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : December 20, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: IUD during CS Device: IUD during CS
IUD insertion during CS
Active Comparator: IUD after puerperium Device: IUD after puerperium
IUD after puerperium
Outcome Measures
Primary Outcome Measures :
  1. IUD expulsion rate [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Bleeding [ Time Frame: 6 weeks ]
    number of pads changed per day

  2. Degree of Pain [ Time Frame: 6 weeks ]
    Visual Analogue Scale from 1 to10 (0 being no pain and 10 maximum pain tolerated)

  3. dyspareunia [ Time Frame: 6 weeks ]
    Visual Analogue Scale from 0 to10 (0 being no pain and 10 maximum pain tolerated)

  4. patient satisfaction [ Time Frame: 6 weeks ]
    Visual Analogue Scale from 0 to10 (0 being maximum dis-satisfaction and 10 maximum satisfaction)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pregnant woman aged between 18 to 40 years old.
  2. Scheduled for elective cesarean section at gestational age between 37 to 42 weeks.
  3. Body mass index between 19-30 kg/m2
  4. Seeking contraception after delivery.

Exclusion Criteria:

  1. History of menorrhagia or severe dysmenorrhea.
  2. History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis).
  3. Patients who have bleeding disorders.
  4. Anemia (Hb < 9 g %).
  5. Chronic depilating diseases reducing immunity such as Diabetes.
  6. Structural uterine anomaly or large uterine fibroids distorting anatomy.
  7. History of previous IUD expulsion or removal for complications.
  8. Unexplained uterine bleeding.
  9. Copper allergy or Wilson disease.
  10. Gestational trophoblastic disease with persistently elevated Beta HCG.
  11. Predisposing factor to postoperative infection (e.g. rupture of membranes prior to admission or delivery of a stillborn baby at cesarean section).
  12. Complications during cesarean section e.g. postpartum hemorrhage.
  13. Cesarean section during placenta previa.
Contacts and Locations

Locations
Layout table for location information
Egypt
Ain Shams University Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Tracking Information
First Submitted Date  ICMJE March 24, 2018
First Posted Date  ICMJE April 10, 2018
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE April 1, 2018
Actual Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2018) 		IUD expulsion rate [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2019)
  • Bleeding [ Time Frame: 6 weeks ]
    number of pads changed per day
  • Degree of Pain [ Time Frame: 6 weeks ]
    Visual Analogue Scale from 1 to10 (0 being no pain and 10 maximum pain tolerated)
  • dyspareunia [ Time Frame: 6 weeks ]
    Visual Analogue Scale from 0 to10 (0 being no pain and 10 maximum pain tolerated)
  • patient satisfaction [ Time Frame: 6 weeks ]
    Visual Analogue Scale from 0 to10 (0 being maximum dis-satisfaction and 10 maximum satisfaction)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2018)
  • Bleeding [ Time Frame: 6 weeks ]
    number of pads changed per day
  • Pain [ Time Frame: 6 weeks ]
    Visual Analogue Scale from 1 to10 (0 being no pain and 10 maximum pain tolerated)
  • dyspareunia [ Time Frame: 6 weeks ]
    Visual Analogue Scale from 0 to10 (0 being no pain and 10 maximum pain tolerated)
  • patient satisfaction [ Time Frame: 6 weeks ]
    Visual Analogue Scale from 0 to10 (0 being maximum dis-satisfaction and 10 maximum satisfaction)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IUD Insertion During Cesarean Section
Official Title  ICMJE Insertion of Intrauterine Contraceptive Device During Cesarean Section: Randomized Clinical Trial
Brief Summary Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical Trial
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Contraception
Intervention  ICMJE
  • Device: IUD during CS
    IUD insertion during CS
  • Device: IUD after puerperium
    IUD after puerperium
Study Arms  ICMJE
  • Active Comparator: IUD during CS
    Intervention: Device: IUD during CS
  • Active Comparator: IUD after puerperium
    Intervention: Device: IUD after puerperium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2018) 		200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 20, 2019
Actual Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Pregnant woman aged between 18 to 40 years old.
  2. Scheduled for elective cesarean section at gestational age between 37 to 42 weeks.
  3. Body mass index between 19-30 kg/m2
  4. Seeking contraception after delivery.

Exclusion Criteria:

  1. History of menorrhagia or severe dysmenorrhea.
  2. History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis).
  3. Patients who have bleeding disorders.
  4. Anemia (Hb < 9 g %).
  5. Chronic depilating diseases reducing immunity such as Diabetes.
  6. Structural uterine anomaly or large uterine fibroids distorting anatomy.
  7. History of previous IUD expulsion or removal for complications.
  8. Unexplained uterine bleeding.
  9. Copper allergy or Wilson disease.
  10. Gestational trophoblastic disease with persistently elevated Beta HCG.
  11. Predisposing factor to postoperative infection (e.g. rupture of membranes prior to admission or delivery of a stillborn baby at cesarean section).
  12. Complications during cesarean section e.g. postpartum hemorrhage.
  13. Cesarean section during placenta previa.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03492034
Other Study ID Numbers  ICMJE AS1750
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohamed S Sweed, MD, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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