Reproductive Health Education, Birth Control and Sexual Quality of Life in Ectopic Pregnancy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Reproductive Health Counseling and Educational Brochure
  Structured reproductive health counseling focusing on contraception and sexual health after ectopic pregnancy, supported by an educational brochure provided after completion of medical or surgical treatment.

Первичные конечные точки

• Contraceptive intention [Срок оценки: Baseline (at discharge) and 1 month after intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Raine-Bennett TR, Rocca CH. Development of a brief questionnaire to assess contraceptive intent. Patient Educ Couns. 2015 Nov;98(11):1425-30. doi: 10.1016/j.pec.2015.05.016. Epub 2015 Jun 3. PMID 26104994
• Symonds T, Boolell M, Quirk F. Development of a questionnaire on sexual quality of life in women. J Sex Marital Ther. 2005 Oct-Dec;31(5):385-97. doi: 10.1080/00926230591006502. PMID 16169822
• Mullany K, Minneci M, Monjazeb R, C Coiado O. Overview of ectopic pregnancy diagnosis, management, and innovation. Womens Health (Lond). 2023 Jan-Dec;19:17455057231160349. doi: 10.1177/17455057231160349. PMID 36999281
• Khajoei Nejad F, Rafati F, Rafati S, Dastyar N. The association between sexual function, quality of marital relationship and associated factors in women with a history of ectopic pregnancy: a cross-sectional study in Iran. BMC Womens Health. 2023 Sep 21;23(1):506. doi: 10.1186/s12905-023-02635-2. PMID 37735651
• Hendriks E, Rosenberg R, Prine L. Ectopic Pregnancy: Diagnosis and Management. Am Fam Physician. 2020 May 15;101(10):599-606. PMID 32412215
• Ban Y, Shen J, Wang X, Zhang T, Lu X, Qu W, Hao Y, Mao Z, Li S, Tao G, Wang F, Zhao Y, Zhang X, Zhang Y, Zhang G, Cui B. Cesarean Scar Ectopic Pregnancy Clinical Classification System With Recommended Surgical Strategy. Obstet Gynecol. 2023 May 1;141(5):927-936. doi: 10.1097/AOG.0000000000005113. Epub 2023 Apr 5. PMID 37023450
• Azin SA, Golbabaei F, Warmelink JC, Eghtedari S, Haghani S, Ranjbar F. Association of depression with sexual function in women with history of recurrent pregnancy Loss: descriptive-correlational study in Tehran, Iran. Fertil Res Pract. 2020 Dec 8;6(1):21. doi: 10.1186/s40738-020-00089-w. PMID 33372644

Идентификаторы

NCT: NCT07431411 · 25-2.1T/67

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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