跳至主要内容
临床试验/NCT07431411
NCT07431411尚未招募不适用

The Effect of Reproductive Health Education on Contraceptive Method Use Intention and Sexual Life Quality of Women Diagnosed With Ectopic Pregnancy

Buket Kömürcü0 个研究点目标入组 102 人开始时间: 2026年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
102
主要终点
Contraceptive intention

研究概览

简要总结

Ectopic pregnancy (EP) is defined as the implantation of a fertilized ovum outside the uterine cavity, most commonly in the fallopian tubes. EP is a potentially life-threatening condition due to the risk of tubal rupture and intra-abdominal bleeding. Management of ectopic pregnancy may involve medical or surgical treatment, often requiring hospitalization.

Following treatment and discharge, women may experience physical, emotional, and sexual health challenges. In addition, the need for effective contraception after ectopic pregnancy treatment is critical due to the risk of recurrent ectopic pregnancy and the potential teratogenic effects of treatment agents such as methotrexate. However, limited data are available regarding contraceptive intentions and sexual quality of life after ectopic pregnancy treatment in Türkiye.

This study aims to evaluate contraceptive intention and sexual quality of life in women treated for ectopic pregnancy and to examine the relationship between length of hospital stay, contraceptive intention, and sexual quality of life. Data will be collected using the Participant Information Form, the Contraceptive Intention Scale (CIS), and the Sexual Life Quality Scale-Women (SLQS-W). In addition, a reproductive health educational brochure will be provided to participants as part of post-treatment counseling.

详细描述

This study is a randomized controlled trial conducted among women diagnosed with ectopic pregnancy who have completed medical or surgical treatment. Eligible participants are women aged 18 years and older who are clinically stable at the time of discharge.

Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive standard post-treatment care in addition to structured reproductive health counseling supported by an educational brochure addressing contraception and sexual health after ectopic pregnancy. The control group will receive standard post-treatment care only.

Data will be collected at baseline and at follow-up using validated instruments. Sociodemographic and clinical characteristics will be obtained using the Participant Information Form. Contraceptive intention will be assessed using the Contraceptive Intention Scale (CIS), and sexual quality of life will be evaluated using the Sexual Life Quality Scale-Women (SLQS-W).

Length of hospital stay and treatment characteristics will be recorded. The primary outcomes of the study are contraceptive intention and sexual quality of life. The relationship between length of hospital stay, contraceptive intention, and sexual quality of life will be analyzed between the intervention and control groups.

Participation is voluntary, and written informed consent will be obtained from all participants prior to enrollment. The study has received ethical approval from the Ege University Medical Research Ethics Committee.

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
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

入选标准

  • Women admitted to the Obstetrics and Gynecology clinics at Izmir City Hospital,
  • Aged 18 years and older,
  • Diagnosed with ectopic pregnancy,
  • Able to read and write in Turkish,
  • Voluntarily agree to participate in the study.

排除标准

  • Women undergoing infertility treatment,
  • Women requesting tubal ligation.

研究组 & 干预措施

Intervention Group

Experimental

Participants in this group will receive standard post-treatment care in addition to structured reproductive health counseling supported by an educational brochure addressing contraception and sexual health after ectopic pregnancy.

干预措施: Reproductive Health Counseling and Educational Brochure (Behavioral)

Control Group

No Intervention

Participants in this group will receive standard post-treatment care only.

结局指标

主要结局

Contraceptive intention

时间窗: Baseline (at discharge) and 1 month after intervention

Contraceptive intention will be assessed using the Contraceptive Intention Scale (CIS), which measures women's intention to use effective contraception after ectopic pregnancy treatment.

次要结局

未报告次要终点

研究者

发起方
Buket Kömürcü
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Buket Kömürcü

Principal Investigator

Ege University

相似试验