Sexual Health Education During PregnancyNCT07497971
Utilizing Electronic Modules to Educate on Sexual Health Practices During Pregnancy
A study testing Standard ACOG Educational Article and Interactive Sexual Health Educational Module in people with Sexual Health Education During Pregnancy and Communication About Sexual Health in Prenatal Care, run by Loyola University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexual Health Education During Pregnancy, Communication About Sexual Health in Prenatal Care, Sexual Function and Intimacy in Pregnancy
- What is being tested?
- Standard ACOG Educational Article and Interactive Sexual Health Educational Module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2026to Feb 2027
- 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
- Pregnant individuals at or beyond 12 weeks gestation
- Age 18 years or older
- English speaking with English reading proficiency
- Experiencing a low risk pregnancy with no major complications
- Not currently followed by Maternal-Fetal Medicine (MFM) for high risk pregnancy management
Who cannot join
- Pregnancy complications requiring management by Maternal-Fetal Medicine (MFM)
- Placed on pelvic rest
- Advised by their provider to abstain from sexual intercourse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Mary Lynn, DO, 708-327-1450, MLYNN@lumc.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Sexual Health Education During Pregnancy, Communication About Sexual Health in Prenatal Care, Sexual Function and Intimacy in Pregnancy
- Being tested
- Standard ACOG Educational Article, Interactive Sexual Health Educational Module
- Keywords
- Pregnancy, Sexual health, Prenatal education, Patient education, Digital health education, Female Sexual Function Index, Communication with healthcare providers, Intimacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ACOG Educational ArticleBehavioural
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
Interactive Sexual Health Educational ModuleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Interactive Educational Module | Experimental | 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. Receives: Behavioral: Interactive Sexual Health Educational Module |
| Arm 2: Standard Educational Article | Active comparator | 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. Receives: Behavioral: Standard ACOG Educational Article |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-test), immediately post-intervention, and 2 weeks post-intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (pre-test) and 2 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start28 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sexual Health Education During 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 are randomly assigned to either an interactive educational module or a standard educational article, with outcomes assessed through pre-test, post-test, and two-week follow-up surveys.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Collaborators
- The international society for the study of women's sexual health
- Responsible party
- Principal investigator, Mary Lynn, Loyola University
- Investigators
- Mary Lynn, DO, Principal investigator, Loyola University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497971
- Sponsor's protocol ID
- 219476
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Aksoy Derya Y, Gok Ugur H, Ozsahin Z. Effects of demographic and obstetric variables with body image on sexual dysfunction in pregnancy: A cross-sectional and comparative study. Int J Nurs Pract. 2020 Jun;26(3):e12829. doi: 10.1111/ijn.12829. Epub 2020 Mar 10.
PubMed 32155306Corbacioglu Esmer A, Akca A, Akbayir O, Goksedef BP, Bakir VL. Female sexual function and associated factors during pregnancy. J Obstet Gynaecol Res. 2013 Jun;39(6):1165-72. doi: 10.1111/jog.12048. Epub 2013 May 30.
PubMed 23718891Mohammadi M, Khani M. Comparing the effect of face-to-face education and using educational films on couples' sexual dysfunction during pregnancy. J Educ Health Promot. 2021 Sep 30;10:335. doi: 10.4103/jehp.jehp_1535_20. eCollection 2021.
PubMed 34761021Bartellas E, Crane JM, Daley M, Bennett KA, Hutchens D. Sexuality and sexual activity in pregnancy. BJOG. 2000 Aug;107(8):964-8. doi: 10.1111/j.1471-0528.2000.tb10397.x.
PubMed 10955426Cassis C, Mukhopadhyay S, Morris E, Giarenis I. What happens to female sexual function during pregnancy? Eur J Obstet Gynecol Reprod Biol. 2021 Mar;258:265-268. doi: 10.1016/j.ejogrb.2021.01.003. Epub 2021 Jan 15.
PubMed 33485263Bahrami Vazir E, Mohammad-Alizadeh-Charandabi S, Kamalifard M, Ghelichkhani F, Mohammadi A, Mirghafourvand M. The correlation between sexual dysfunction and intimate partner violence in young women during pregnancy. BMC Int Health Hum Rights. 2020 Sep 14;20(1):24. doi: 10.1186/s12914-020-00245-9.
PubMed 32928215
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Electronic Modules to Educate on Sexual Health Practices During Pregnancy
- ClinicalTrials.gov ID
- NCT07497971
- Acronym / sponsor ID
- 219476
- Conditions
- Sexual Health Education During Pregnancy, Communication About Sexual Health in Prenatal Care, Sexual Function and Intimacy in Pregnancy
- Keywords
- Pregnancy, Sexual health, Prenatal education, Patient education, Digital health education, Female Sexual Function Index, Communication with healthcare providers, Intimacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Collaborators
- The international society for the study of women's sexual health
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Mar 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either an interactive educational module or a standard educational article, with outcomes assessed through pre-test, post-test, and two-week follow-up surveys.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Interactive Educational Module | Experimental | Behavioral: Interactive Sexual Health Educational ModuleParticipants 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. |
| Arm 2: Standard Educational Article | Active comparator | Behavioral: Standard ACOG Educational ArticleParticipants 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. |
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)
- Pregnant individuals at or beyond 12 weeks gestation
- Age 18 years or older
- English speaking with English reading proficiency
- Experiencing a low risk pregnancy with no major complications
- Not currently followed by Maternal-Fetal Medicine (MFM) for high risk pregnancy management
Key exclusion criteria (3 listed)
- Pregnancy complications requiring management by Maternal-Fetal Medicine (MFM)
- Placed on pelvic rest
- Advised by their provider to abstain from sexual intercourse
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 |
|---|---|---|
| Standard ACOG Educational ArticleA 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 | Behavioural | Arm 2: Standard Educational Article |
| Interactive Sexual Health Educational ModuleAn 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. | Behavioural | Arm 1: Interactive Educational Module |
Primary outcome
Change in Sexual Health Knowledge During Pregnancy
Time frame: Baseline (pre-test), immediately post-intervention, and 2 weeks post-intervention
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.
2 secondary outcomes
Change in 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
Time frame: Baseline (pre-test) and 2 weeks post-intervention
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 26 Aug 2026.
- Background: PubMed 32155306Aksoy Derya Y, Gok Ugur H, Ozsahin Z. Effects of demographic and obstetric variables with body image on sexual dysfunction in pregnancy: A cross-sectional and comparative study. Int J Nurs Pract. 2020 Jun;26(3):e12829. doi: 10.1111/ijn.12829. Epub 2020 Mar 10.
- Background: PubMed 23718891Corbacioglu Esmer A, Akca A, Akbayir O, Goksedef BP, Bakir VL. Female sexual function and associated factors during pregnancy. J Obstet Gynaecol Res. 2013 Jun;39(6):1165-72. doi: 10.1111/jog.12048. Epub 2013 May 30.
- Background: PubMed 34761021Mohammadi M, Khani M. Comparing the effect of face-to-face education and using educational films on couples' sexual dysfunction during pregnancy. J Educ Health Promot. 2021 Sep 30;10:335. doi: 10.4103/jehp.jehp_1535_20. eCollection 2021.
- Background: PubMed 10955426Bartellas E, Crane JM, Daley M, Bennett KA, Hutchens D. Sexuality and sexual activity in pregnancy. BJOG. 2000 Aug;107(8):964-8. doi: 10.1111/j.1471-0528.2000.tb10397.x.
- Background: PubMed 33485263Cassis C, Mukhopadhyay S, Morris E, Giarenis I. What happens to female sexual function during pregnancy? Eur J Obstet Gynecol Reprod Biol. 2021 Mar;258:265-268. doi: 10.1016/j.ejogrb.2021.01.003. Epub 2021 Jan 15.
- Background: PubMed 32928215Bahrami Vazir E, Mohammad-Alizadeh-Charandabi S, Kamalifard M, Ghelichkhani F, Mohammadi A, Mirghafourvand M. The correlation between sexual dysfunction and intimate partner violence in young women during pregnancy. BMC Int Health Hum Rights. 2020 Sep 14;20(1):24. doi: 10.1186/s12914-020-00245-9.
- Individual participant dataSharing planned: 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.
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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.
Mary Lynn, DO principal investigator
Loyola University Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard ACOG Educational Article and Interactive Sexual Health Educational Module in people with Sexual Health Education During Pregnancy and Communication About Sexual Health in Prenatal Care, run by Loyola University at 1 site in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mary Lynn, DO (708-327-1450, MLYNN@lumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sexual Health Knowledge During Pregnancy (time frame: Baseline (pre-test), immediately post-intervention, and 2 weeks post-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 NCT07497971, which also lists 6 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 26 Aug 2026.