Ectopic PregnancyNCT07431411
Reproductive Health Education, Birth Control and Sexual Quality of Life in Ectopic Pregnancy
A study testing Reproductive Health Counseling and Educational Brochure in people with Ectopic Pregnancy, run by Buket Kömürcü.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Reproductive Health Counseling and Educational Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 18 Feb 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Women undergoing infertility treatment,
- Women requesting tubal ligation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ectopic Pregnancy
- Being tested
- Reproductive Health Counseling and Educational Brochure
- Keywords
- ectopic pregnancy, reproductive health, quality of sexual life, health education
- Medical subject headings
- Pregnancy, Ectopic, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reproductive Health Counseling and Educational BrochureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Reproductive Health Counseling and Educational Brochure |
| Control Group | No intervention | Participants in this group will receive standard post-treatment care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive intention
Contraceptive intention will be assessed using the Contraceptive Intention Scale (CIS), which measures women's intention to use effective contraception after ectopic pregnancy treatment.
Measured: Baseline (at discharge) and 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start18 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ectopic PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to an intervention group receiving structured reproductive health counseling in addition to standard care, or to a control group receiving standard care only.
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buket Kömürcü
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir City Hospital, Ege University
- Responsible party
- Sponsor-investigator, Buket Kömürcü, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431411
- Sponsor's protocol ID
- 25-2.1T/67
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26104994Symonds 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.
PubMed 16169822Mullany 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.
PubMed 36999281Khajoei 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.
PubMed 37735651Hendriks E, Rosenberg R, Prine L. Ectopic Pregnancy: Diagnosis and Management. Am Fam Physician. 2020 May 15;101(10):599-606.
PubMed 32412215Ban 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.
PubMed 37023450Azin 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.
PubMed 33372644
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reproductive Health Education on Contraceptive Method Use Intention and Sexual Life Quality of Women Diagnosed With Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT07431411
- Acronym / sponsor ID
- 25-2.1T/67
- Conditions
- Ectopic Pregnancy
- Keywords
- ectopic pregnancy, reproductive health, quality of sexual life, health education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Buket KömürcüUniversity, hospital or other
- Collaborators
- Izmir City Hospital, Ege University
- Study start
- 18 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to an intervention group receiving structured reproductive health counseling in addition to standard care, or to a control group receiving standard care only.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Reproductive Health Counseling and Educational BrochureParticipants 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. |
| Control Group | No intervention | –Participants in this group will receive standard post-treatment care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Women undergoing infertility treatment,
- Women requesting tubal ligation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reproductive Health Counseling and Educational BrochureStructured 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. | Behavioural | Intervention Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 26104994Raine-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.
- Background: PubMed 16169822Symonds 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.
- Background: PubMed 36999281Mullany 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.
- Background: PubMed 37735651Khajoei 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.
- Background: PubMed 32412215Hendriks E, Rosenberg R, Prine L. Ectopic Pregnancy: Diagnosis and Management. Am Fam Physician. 2020 May 15;101(10):599-606.
- Background: PubMed 37023450Ban 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.
- Background: PubMed 33372644Azin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Reproductive Health Counseling and Educational Brochure in people with Ectopic Pregnancy, run by Buket Kömürcü.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Buket Komurcu (+905074403162, buketkmrc1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive intention (time frame: Baseline (at discharge) and 1 month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07431411, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.