NCT07497971

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Progress33%
May 2026Feb 2027

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

March 23, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

PregnancySexual healthPrenatal educationPatient educationDigital health educationFemale Sexual Function IndexCommunication with healthcare providersIntimacy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (pre-test), immediately post-intervention, and 2 weeks post-intervention

Secondary Outcomes (2)

  • Change in Comfort Discussing Sexual Health With Healthcare Providers

    Baseline (pre-test), immediately post-intervention, and 2 weeks post-intervention

  • Change in Sexual Function During Pregnancy

    Baseline (pre-test) and 2 weeks post-intervention

Study Arms (2)

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.

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.

Behavioral: Standard ACOG Educational Article

Interventions

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

Arm 2: Standard Educational Article

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.

Arm 1: Interactive Educational Module

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy complications requiring management by Maternal-Fetal Medicine (MFM)
  • Placed on pelvic rest
  • Advised by their provider to abstain from sexual intercourse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (6)

  • 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.

    PMID: 32155306BACKGROUND
  • Corbacioglu 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.

    PMID: 23718891BACKGROUND
  • Mohammadi 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.

    PMID: 34761021BACKGROUND
  • Bartellas 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.

    PMID: 10955426BACKGROUND
  • Cassis 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.

    PMID: 33485263BACKGROUND
  • Bahrami 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.

    PMID: 32928215BACKGROUND

Study Officials

  • Mary Lynn, DO

    Loyola University Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Lynn, DO

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Obstetrics and Gynecology

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations