Does Skyla Insertion Timing Impact Bleeding?

Rutgers, The State University of New Jersey132 enrolled

Overview

Women presenting for contraception will be offered the IUS Skyla and study participation. Daily bleeding will be collected for a total of 90 days and correlated with insertion timing and baseline endometrial thickness.

Study Type

OBSERVATIONAL

Enrollment

132

Conditions

Vaginal Bleeding

Interventions

Intrauterine systemDEVICE

Women having the Skyla intrauterine system at different times during their menstrual cycle report their bleeding patterns through daily texts.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women aged 18-45 * Parous or nulliparous * Desire Skyla for contraception * Regular menstrual cycles (21-35 days) * Working mobile phone and willing to accept text messages and report daily bleeding data for 90 days Exclusion Criteria: * Vaginal or cesarean delivery in the past 12 weeks * Abortion in the past 6 weeks * Uterine anomaly distorting the uterus * Acute pelvic inflammatory disease * Uterine bleeding of unknown etiology * Acute liver disease or tumor * History of progestin-sensitive cancer * Abnormal pap smear awaiting diagnostic or therapeutic intervention

Locations (3)

Planned Parenthood

Morristown, New Jersey, United States

NJFPC

Newark, New Jersey, United States

SHS

Newark, New Jersey, United States

Outcomes

Primary Outcomes

Bleeding and spotting as collected by daily texts

Composite variable of bleeding and spotting for 90 days after Skyla IUS insertion

Time frame: 90 days

Data from ClinicalTrials.gov

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