Does Skyla Insertion Timing Impact Bleeding?
Completed
- Conditions
- Vaginal Bleeding
- Interventions
- Device: Intrauterine system
- Registration Number
- NCT03074903
- Lead Sponsor
- Rutgers, The State University of New Jersey
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 132
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Early cycle insertion Intrauterine system Participants in this group have the intrauterine system inserted during the first seven days of their menstrual cycle. Late cycle insertion Intrauterine system Participants in this group have the intrauterine system inserted during the remainder of their cycle.
- Primary Outcome Measures
Name Time Method Bleeding and spotting as collected by daily texts 90 days Composite variable of bleeding and spotting for 90 days after Skyla IUS insertion
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Planned Parenthood
🇺🇸Morristown, New Jersey, United States
NJFPC
🇺🇸Newark, New Jersey, United States
SHS
🇺🇸Newark, New Jersey, United States