NCT07431411

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 16, 2026

Last Update Submit

February 23, 2026

Conditions

Keywords

ectopic pregnancyreproductive healthquality of sexual lifehealth education

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (at discharge) and 1 month after intervention

Study Arms (2)

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.

Behavioral: Reproductive Health Counseling and Educational Brochure

Control Group

NO INTERVENTION

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

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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: 26104994BACKGROUND
  • 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: 16169822BACKGROUND
  • 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: 36999281BACKGROUND
  • 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: 37735651BACKGROUND
  • Hendriks E, Rosenberg R, Prine L. Ectopic Pregnancy: Diagnosis and Management. Am Fam Physician. 2020 May 15;101(10):599-606.

    PMID: 32412215BACKGROUND
  • 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: 37023450BACKGROUND
  • 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: 33372644BACKGROUND

MeSH Terms

Conditions

Pregnancy, EctopicHealth Education

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 24, 2026

Study Start

February 18, 2026

Primary Completion

June 30, 2026

Study Completion

July 30, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share