- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07431411
Reproductive Health Education, Birth Control and Sexual Quality of Life in Ectopic Pregnancy
The Effect of Reproductive Health Education on Contraceptive Method Use Intention and Sexual Life Quality of Women Diagnosed With Ectopic Pregnancy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Buket Komurcu
- Phone Number: +905074403162
- Email: buketkmrc1@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Women undergoing infertility treatment,
- Women requesting tubal ligation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
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.
|
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.
|
|
No Intervention: Control Group
Participants in this group will receive standard post-treatment care only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Contraceptive intention
Time Frame: 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.
|
Baseline (at discharge) and 1 month after intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Hendriks E, Rosenberg R, Prine L. Ectopic Pregnancy: Diagnosis and Management. Am Fam Physician. 2020 May 15;101(10):599-606.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-2.1T/67
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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