Use of Norethindrone Acetate for Management of Bleeding Associated With the Etonogestrel Contraceptive Implant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Impact of Aygestin (and Dose of Aygestin) on the Management of Bothersome Bleeding Associated With the Etonogestrel Contraceptive Implant
研究概览
简要总结
The overall objective of this study is to confirm that oral progesterone is an effective way to manage bothersome bleeding; thus increasing the rate of continuation of the etonogestrel contraceptive implant in adolescents.
详细描述
The investigators will conduct a prospective study of adolescents using the etonogestrel contraceptive implant. Participants will be recruited from the Kosair Children's Hospital Gynecology Specialists practice in Louisville, Kentucky. This practice provides care to a diverse population of females, from a wide range of socioeconomic statuses, age birth to 25 years.
All patient presenting and choosing to have an implant placed will be offered participation. All enrollments will be voluntary. Participants will not receive compensation for their participation. After obtaining informed consent and assent, participants will provide baseline demographic information, including: age, race/ethnicity, zip code of residence, health insurance provider, number of current and past partners, use of prior contraceptive methods, concomitant condom use, sexually transmitted infection history,smoking status, weight and height. The date of etonogestrel implant insertion will be confirmed.
All patients using etonogestrel contraceptive implants will receive daily SMS texts in the evening via the Qualtrics SMS program asking them to respond with their bleeding pattern that day. The investigators will record responses according to the World Health Organization definitions of bleeding: (a) bleeding day, (b) spotting day, (c) bleeding--- free day [see Table I for WHO bleeding definitions]. At their initial follow---up visit 3 months after Nexplanon insertion, the investigators will identify those who report "bothersome" bleeding patterns. For the purpose of this study, "bothersome" bleeding will be defined as prolonged and/or frequent bleeding, as characterized by World Health Organization---recommended definitions of bleeding. The definitions are listed in Table I.
Bleeding day Any day with vaginal discharge containing blood that required more than 1 sanitary pad or tampon per day
Spotting day Any day with vaginal discharge containing blood that required at most one sanitary pad or tampon per day Bleeding---free day A day during which neither bleeding nor spotting was reported
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria will include any post---menarchal female presenting to the Kosair Children's Hospital Gynecologic Specialist practice, who desires to use the etonogestrel contraceptive implant and has access to a mobile phone device.
排除标准
- 未提供
研究组 & 干预措施
Norethindrone acetate (aygestin)
Norethindrone acetate (aygestin) will be used to manage bothersome bleeding. Patients will be prescribed aygestin 5 mg by mouth twice daily for one month, followed by aygestin 5 mg by mouth once daily for two months. Medication will then be discontinued. Patients will be evaluated in the office three months after medication initiation, and then again six months after medication initiation. If the patient is unable to take norethindrone acetate (aygestin) due to medical contraindications or cost, they will receive medroxyprogesterone acetate (provera) 10 mg once daily as alternate oral progesterone. Figure 1 below highlights the study
干预措施: Norethindrone acetate (Drug)
结局指标
主要结局
Impact of Aygestin (and Dose of Aygestin) on the Management of Bothersome Bleeding Associated With the Etonogestrel Contraceptive Implant
时间窗: Initial 3 months of baseline collection (medicine free); For intervention group, 3 months of medicine, followed by 3 months of medicine free; For control group, 6 months of medicine free.
"Bothersome bleeding" was defined per WHO classification as either frequent bleeding (greater than 5 bleeding-spotting episodes in a 90-day reference period) or prolonged bleeding (any bleeding-spotting episode, uninterrupted, lasting greater than 14 days in a 90-day reference period) The scale used was derived from the WHO classification system: Bleeding Day (assigned value = 1) Spotting Day (assigned value = .5) Bleeding Free Day (assigned value = 0) Prefer not to answer today (assigned value = missing) Higher scores (average of the time period) indicate more bothersome bleeding; low scores indicate less bothersome bleeding. Less bothersome bleeding is the desired outcome. Note, the scale is not a published scale but rather was constructed for this study.
次要结局
未报告次要终点
研究者
Scott LaJoie
Principal Investigator
Norton Healthcare