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临床试验/NCT04273984
NCT04273984已完成4 期

Efficacy and Safety of Different Doses of Vaginal Misoprostol Prior to Intra Uterine Contraceptive Device Insertion

Ain Shams University2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
180
试验地点
2
主要终点
Pain scores

研究概览

简要总结

investigators aim through this study to evaluate and compare the Safety and efficacy of different doses of misoprostol prior to IUCD insertion among women with nulliparous cervix beside the rate of occurrence of adverse effects.

详细描述

Today there is an ever-increasing variety of effective contraceptive methods. Although all have side effects, they offer a lower risk than that conferred by pregnancy Contraceptive methods are classified according to their effectiveness. The top tier offer the highest level of effectiveness (defined as <two pregnancies per 100 women per year) and fulfill the criteria of ease of use, long duration of action, minimal need for return visits to the clinic and minimal user motivation or intervention. These methods include intrauterine contraception, sub dermal contraceptive implants and male and female sterilization The American Congress of Obstetricians and Gynecologists encourages all women, especially adolescents, to use long-acting reversible contraception.

Although intrauterine devices (IUDs) are safe, reliable and highly effective forms of long- acting reversible contraception and has a very low failure rate (0.2-0.6 per 100 women per year) , it is used by only 7.6% and 14.5% of contraceptive users in developed and developing countries, respectively

According to the latest practice recommendations for contraceptive use by the Centers for Disease Control and Prevention, the potential barriers to IUD use include anticipated insertion pain and health care providers' concerns about difficult insertion ( It is therefore important to identify effective approaches to ease IUD insertion in order to overcome obstacles hindering IUD use

Insertion-associated pain is related to speculum insertion, tenaculum traction on the cervix, sounding of the uterus, passing of the insertion tube through the cervix and placement of the device within the uterine cavity

Failure of insertion occurs in up to 14% and 20% of parous and nulliparous women, respectively 13).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Non-pregnant,
  • Nulliparous cervix: no previous vaginal delivery or any attempt of vaginal delivery,
  • Seeking for IUD insertion,
  • Signing an informed consent to participate in the study,

排除标准

  • Pregnancy or signs of pregnancy,
  • Signs of cervicitis,
  • Any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids and intrauterine adhesions,
  • Women with any kind of pelvic pain,
  • Abnormal uterine bleeding,
  • History of cervical surgery,• Vaginal delivery,
  • Contraindication to misoprostol as allergy,
  • Administration of any analgesics last 12h,
  • Withdrawal of consent

研究组 & 干预措施

1- Group 1 (misoprostol 200 mcg

Active Comparator

Group 1 :will take 1 tablet (200 mcg) of misoprostol and 1 placebo tablet,

.,

干预措施: Misoprostol (Drug)

2- Group 2 (misoprostol 100 mcg)

Active Comparator

Group 2: will take1 tablet (100 mcg) of misoprostol and 1 placebo tablet,

干预措施: Misoprostol (Drug)

3- Group 3 (placebo group)

Placebo Comparator

Group 3 ): will take2 placebo tablets

干预措施: Misoprostol (Drug)

结局指标

主要结局

Pain scores

时间窗: during insertion of IUCD

Pain scores will be measured using a visual analogue scale (VAS) consisting of a 10 cm horizontal straight line on which 0 cm corresponded to no pain and 10 cm to the worst pain. The pain score will be measured within 5 min of insertion of the IUD tube.

次要结局

  • The ease of IUD insertion(during insertion ofIUCD)
  • Successful IUD insertion(5minutes after insertion of IUCD)
  • The duration of insertion in seconds(during insertion ofIUCD)
  • The women's level of satisfaction at the end of insertion(1 miute after insertion of IUCD)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

shiamaa ghazal helmy

Principal Investigator

Ain Shams University

研究点 (2)

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