An interventional study of Standard ACOG Educational Article and Interactive Sexual Health Educational Module in Sexual Health Education During Pregnancy, Communication About Sexual Health in Prenatal Care and Sexual Function and Intimacy in Pregnancy, sponsored by Loyola University. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Loyola University · Not applicable, Interventional, and Prevention
This study looks at whether an interactive online education module can improve knowledge, comfort, and communication about sexual health during pregnancy. Many pregnant individuals experience changes in sexual function and intimacy but may feel uncomfortable discussing these topics or may have misconceptions about what is safe during pregnancy.
Participants who are pregnant and receiving routine prenatal care will be randomly assigned to one of two groups. One group will complete an interactive, evidence-based educational module focused on sexual health and intimacy during pregnancy. The other group will review a standard educational article from the American College of Obstetricians and Gynecologists (ACOG) about sexual activity during pregnancy.
Participants will complete surveys before and after reviewing the educational material, as well as a follow-up survey two weeks later. These surveys will measure knowledge about sexual health during pregnancy, comfort discussing sexual concerns with healthcare providers, and sexual function. The goal of this study is to determine whether an interactive educational approach can better support pregnant individuals' understanding of sexual health and encourage open communication with healthcare providers during pregnancy.
This is a prospective, randomized controlled study designed to evaluate the effectiveness of an interactive educational module on sexual health knowledge, comfort with communication, and sexual function during pregnancy.
Pregnant participants receiving routine prenatal care at the Loyola University Medical Center outpatient women's health clinic will be recruited during clinic visits. Eligible participants will be adults aged 18 years or older with a low-risk pregnancy at or beyond 12 weeks' gestation who are English-speaking and able to read English. Individuals with pregnancy complications requiring management by maternal-fetal medicine or with contraindications to sexual activity during pregnancy will be excluded.
Participants will be randomized in a 1:1 ratio to one of two study arms. The intervention group will complete a pre-test survey, view an interactive, evidence-based educational module addressing sexual health, intimacy, and common misconceptions during pregnancy, and then complete an immediate post-test survey. The control group will complete a pre-test survey, review a standard ACOG educational article on sexual activity during pregnancy, and then complete an immediate post-test survey. All participants will receive a follow-up survey two weeks after the initial intervention.
Primary outcomes include changes in knowledge about sexual health during pregnancy. Secondary outcomes include changes in comfort discussing sexual concerns with healthcare providers and changes in sexual function as measured by the Female Sexual Function Index (FSFI). Survey data will be collected electronically using REDCap and analyzed using a per-protocol approach.
719 studies on the registry are indexed under Communication; 159 are open to participants now.
This study's planned enrollment of 100 is below the median of 144 across 571 interventional studies indexed under Communication.
Browse Communication studies →Loyola University is the lead sponsor of 134 studies on the registry; 15 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 23 (88%) have results posted.
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Exclusion Criteria:
Participants assigned to this arm will complete a pre-test survey, review an interactive, evidence-based online educational module focused on sexual health, intimacy, and common misconceptions during pregnancy, and then complete an immediate post-test survey. A follow-up survey will be completed two weeks later.
Behavioral: Interactive Sexual Health Educational Module
Participants assigned to this arm will complete a pre-test survey, review a standard educational article from the American College of Obstetricians and Gynecologists (ACOG) on sexual activity during pregnancy, and then complete an immediate post-test survey. A follow-up survey will be completed two weeks later.
Behavioral: Standard ACOG Educational Article
A publicly available educational article from the American College of Obstetricians and Gynecologists (ACOG) titled "Is it Safe to Have Sex During Pregnancy?" providing general guidance on sexual activity during pregnancy
An interactive, web-based educational module designed to educate pregnant individuals on sexual function, intimacy, and safe sexual practices during pregnancy. The module addresses common myths, physiological changes, communication with partners and healthcare providers, and evidence-based guidance regarding sexual activity during pregnancy.
Change in Sexual Health Knowledge During Pregnancy
Change in participant knowledge regarding sexual health, intimacy, and safety of sexual activity during pregnancy, as measured by a study-specific knowledge survey administered before and after the educational intervention. The outcome is defined as the number of correct responses, with scores ranging from 0 to the total number of survey questions; higher scores indicate greater sexual health knowledge.
Time frame: Baseline (pre-test), immediately post-intervention, and 2 weeks post-intervention
Change in Comfort Discussing Sexual Health With Healthcare Providers
Change in participant-reported comfort discussing sexual health concerns with healthcare providers, as measured using a 5-point Likert scale ranging from 1 ("Not at all comfortable") to 5 ("Extremely comfortable"). Higher scores indicate greater comfort discussing sexual health with healthcare providers.
Time frame: Baseline (pre-test), immediately post-intervention, and 2 weeks post-intervention
Change in Sexual Function During Pregnancy
Change in sexual function as measured by the Female Sexual Function Index (FSFI), a validated 19-item questionnaire assessing female sexual function. Total FSFI scores range from 2 to 36, with higher scores indicating better sexual function. Change in FSFI total score will be assessed following exposure to the educational intervention or control article.
Time frame: Baseline (pre-test) and 2 weeks post-intervention
Plan to share: No — Individual participant data will not be shared. The study team does not have plans or infrastructure in place to support external data sharing, and the informed consent does not include provisions for sharing de-identified participant-level data outside the research team.
Started Feb 2026 (actual). Primary completion is estimated for Feb 2027, 12 months after the start.
Of 390 non-industry interventional studies with no phase under Communication, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 12 months is below that.
Counting every sponsor, half of 394 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
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