Immediate Versus Delayed Insertion of Intrauterine Contraception at the Time of Medical Abortion- An Open-label, Randomized, Multicenter Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 720
- 试验地点
- 7
- 主要终点
- use of intrauterine contraception at 6 months post abortion
研究概览
简要总结
PICO:
Population:
Women with unwanted pregnancy having a medical abortion and fulfilling inclusion and without exclusion criteria and opting for IUC as post abortion contraception. The medical abortion will be carried out according to the Swedish national evidence based guidelines.
Intervention:
Randomized to insertion of IUC within 48 hours after medical abortion.
Control:
Randomized to insertion of IUC at the time of a follow-up visit scheduled 2 to 4 weeks after the abortion according to routine care.
Objectives:
Evaluation of use of IUC, feasibility, safety, compliance, and acceptability of immediate insertion of IUC 0 to 48 hours after medical abortion compared with delayed IUC insertion at 2 to 4 weeks post abortion. The primary outcome measure will be the use of IUC at 6 months in both groups evaluated by telephone calls/emails follow up.
Time plan: Planning: -March 2018 Study start: May 2018 End of recruitment: April 2020 Last patient Last visit April 2021 Analysis: 2021 Report of primary outcome and Safety: 2021
详细描述
Today 90 percent of terminations of pregnancy are medical abortions. Approximately 33 000 medical abortions are performed in Sweden each year and 20-30 percent of these women opt for IUC as post abortion contraception. Thus, the results of this study potentially affect at least 6600-9900 women every year in Sweden alone. A disadvantage with medical abortion compared with surgical abortion is the standard practice of delayed insertion of IUC. It has been shown that 42 percent of women scheduled for delayed insertion after surgical abortion did not return for the follow up and IUC insertion.(5) This problem is common also in medical abortion practice. Immediate insertion could lead to insertion rates close to 100 percent. However, this practice has not been studied for medical abortion.
The background for this trial is the belief that a higher rate of insertion of IUC, perhaps close to 100 percent, within 48 hours after medical abortion, can compensate more than well for a potentially higher rate of expulsion at immediate insertion. A clinically significant difference in IUC use at six months following the medical abortion of at least 20 percent is expected.
This large multicenter, randomized, patient centered clinical trial will investigate the effectiveness, feasibility, continued use, safety and acceptability of immediate insertion of intrauterine contraception within 0-48 hours after a completed medical abortion when compared to delayed IUC insertion at 2-4 weeks post abortion which is current practice.
Aim To study use, safety and patient acceptability of intrauterine contraception after immediate insertion compared with standard insertion 2-4 weeks post medical abortion at 3, 6 and 12 months post abortion.
Drug:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years and older,
- •eligible for medical abortion,
- •opting for post abortion IUC,
- •able and willing to comply with planned follow up.
排除标准
- •Contraindication for medical abortion or
- •Contraindication for IUC (contraindications may be present for LNG-IUSs but the woman may still choose a Cu-IUD and thereby enter the study),
- •inability to give informed consent.
- •Septic abortion
- •Known hypersensiblity/allergy to levonorgestrel or any of the substances added to the LNG-IUS
- •Known abnormal uterine cavity
- •Chorioamnionitis
- •Abortion associated bleeding > 1000ml
- •Uterine atony postabortion
- •Placental retention
- •Therapeutic antibiotic treatment during abortion, (antibiotics used only as prophylaxis is accepted)
- •History of breast cancer
- •If any of the following conditions are present an individual evaluation and decision must be done before inclusion: pelvic or genital infection, cervicitis, immunocompromised women, untreated cervical dysplasia, neoplasia in cervix or uterus, acute liver disease or hepatic neoplasia, migraine or other very severe headache, icterus, high uncontrolled blood pressure, serious arterial disease i.e. stroke or myocardial infarction, acute venous thrombosis
结局指标
主要结局
use of intrauterine contraception at 6 months post abortion
时间窗: 6 months post abortion
use of intrauterine contraception at 6 months post abortion in both groups evaluated through follow up by telephone/email.
次要结局
- Expulsion rate following insertion in both groups(12 months post insertion)
- Complications(12 months post abortion)
- Difference in the proportion of women who successfully have the IUC inserted(10 minutes after (attempted) insertion)
- Pain at time of insertion assessed as millimeters on a 10cm long unmarked Visual Analogue Scale.(10 minutes after (attempted) insertion)
- Reasons for non-attempted insertion of IUC(within 1 month post abortion)
- Pregnancies occurring during the 12 month follow-up(12 months post abortion)
- Continued use of IUC(12 months post abortion)
- Ease of insertion(10 minutes after (attempted) insertion)
- Post-abortion bleeding measured as number of days of spotting during the first 3 months post abortion(max 3 months post abortion)
- proportion of women who would recommend immediate or delayed insertion of IUC post abortion(12 months post abortion)
- proportion of women who would recommend IUC for post abortion contraception(12 months post abortion)
- Post-abortion bleeding measured as number of days of fresh bleeding(max 3 months post abortion)
- The proportion of surgical procedures(3 months post abortion)
研究者
Helena Kopp Kallner
Associate professor, senior consultant obstetrics and gynecology
Karolinska Institutet