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Clinical Trials/NCT03492034
NCT03492034
Completed
Not Applicable

Insertion of Intrauterine Contraceptive Device During Cesarean Section: Randomized Clinical Trial

Ain Shams University1 site in 1 country200 target enrollmentApril 1, 2018
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ConditionsContraception

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Contraception
Sponsor
Ain Shams University
Enrollment
200
Locations
1
Primary Endpoint
IUD expulsion rate
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical Trial

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
December 20, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed S Sweed, MD

Principal Investigator

Ain Shams University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • •History of menorrhagia or severe dysmenorrhea.
  • •History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis).
  • •Patients who have bleeding disorders.
  • •Anemia (Hb \< 9 g %).
  • •Chronic depilating diseases reducing immunity such as Diabetes.
  • •Structural uterine anomaly or large uterine fibroids distorting anatomy.
  • •History of previous IUD expulsion or removal for complications.
  • •Unexplained uterine bleeding.
  • •Copper allergy or Wilson disease.
  • •Gestational trophoblastic disease with persistently elevated Beta HCG.

Outcomes

Primary Outcomes

IUD expulsion rate

Time Frame: 6 weeks

Secondary Outcomes

  • Bleeding(6 weeks)
  • Degree of Pain(6 weeks)
  • dyspareunia(6 weeks)
  • patient satisfaction(6 weeks)

Study Sites (1)

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