Tender Loving Care for Recurrent Pregnancy Loss

NCT06182878 | Recruiting DMC

• 1 other identifier: 23-17302
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this investigational study is to evaluate participation in a weekly, interactive, tender loving care messaging platform impact on pregnancy outcomes in patients with recurrent pregnancy loss. The main questions it aims to answer are: (1) does participation in weekly, interactive tender loving care messages increase live birth rates in patients with recurrent pregnancy loss? (2) Does participation in weekly, interactive tender loving care messages increase patients' quality of life? Does participation in weekly, interactive tender loving care messages decrease patients' depressive symptoms? Participants will be asked to interact with weekly messages providing prenatal counseling and support. Additionally, patients will be asked to complete the fertility quality of life survey several times over the course of the pregnancy.

Conditions

Recurrent Pregnancy Loss

Keywords

Recurrent Pregnancy Loss

Outcome Measures

Primary Outcomes (1)

• Live birth rates

  Live birth is defined as the delivery of at least one live-born infant at or after 22+0 weeks gestational age

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Fertility quality of life survey scores

  Baseline at enrollment of study, repeat assessments at 13 weeks, 28 weeks, and 6 weeks after delivery or after miscarriage

• Depressive symptoms

  through study completion, an average of 1 year

Study Arms (1)

Tender loving care intervention

EXPERIMENTAL

Weekly prenatal counseling messages sent via an online platform.

Behavioral: Tender loving care intervention

Interventions

Tender loving care intervention BEHAVIORAL

Receiving weekly prenatal care counseling messages

Tender loving care intervention

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant individuals receiving their prenatal care at WRNMMC
• Able to speak and understand English
• Less than or equal to 10+0 weeks gestation by last menstrual period (LMP) or dating ultrasound at the time of enrollment
• At least two prior pregnancy losses. Pregnancy losses must be confirmed with laboratory criteria confirming a positive pregnancy test in the military electronic medical record with subsequent resolution (resolution may be reported by patient), or with ultrasound criteria demonstrating an intrauterine gestational sac with subsequent resolution (resolution may be reported by patient).

You may not qualify if:

• Age less than 18 years and older than 44 at time of enrollment
• Unable to speak or understand English
• Current smoker or tobacco use within 30 days
• History of uterine anomaly, coagulopathy, balanced translocation, endometrial polyps, submucosal fibroids, pathology confirmed acute or chronic endometritis, hydrosalpinx, history of Asherman syndrome, poorly controlled endocrinopathies, HIV infection
• History of gonadotoxic therapy or cancerous condition of the female reproductive tract
• Suspicion for or confirmation of an ectopic pregnancy

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

RECRUITING

Study Officials

• David Boedeker, DO

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Boedeker, DO

CONTACT

301-400-2140; david.h.boedeker.mil@health.mil

Kiley Hunkler, MD

CONTACT

301-400-2140; kiley.f.hunkler.mil@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 27, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)