Does Skyla Insertion Timing Impact Bleeding?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-16

Study Completion Date

2017-07-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Vaginal Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Early cycle insertion

Participants in this group have the intrauterine system inserted during the first seven days of their menstrual cycle.

Intrauterine system

Intervention Type DEVICE

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

Late cycle insertion

Participants in this group have the intrauterine system inserted during the remainder of their cycle.

Intrauterine system

Intervention Type DEVICE

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

Interventions

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Intrauterine system

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

Intervention Type DEVICE

Other Intervention Names

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Intrauterine device

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes