ClinicalTrials.gg
RecruitingNCT06182878Updated Apr 22, 2026

Tender Loving Care for Recurrent Pregnancy Loss

An interventional study of Tender loving care intervention in Recurrent Pregnancy Loss, sponsored by Walter Reed National Military Medical Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Walter Reed National Military Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 44 Years
Sex
Female
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Recurrent Pregnancy Loss

Keywords

  • Recurrent Pregnancy Loss
03

In context

Lead sponsor

Walter Reed National Military Medical Center is the lead sponsor of 78 studies on the registry; 20 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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, infection
  • History of gonadotoxic therapy or cancerous condition of the female reproductive tract
  • Suspicion for or confirmation of an ectopic pregnancy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Tender loving care intervention

    Weekly prenatal counseling messages sent via an online platform.

    Behavioral: Tender loving care intervention

Interventions

  • BehavioralTender loving care intervention

    Receiving weekly prenatal care counseling messages

06

What researchers measure

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

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Fertility quality of life survey scores

    Quality of life will be defined using the fertility quality of life scores. The survey is entitled, "Fertility quality of life questionnaire." Survey responses are based on a five-point scale, with responses such as "very good" and "very satisfied" corresponding to better outcomes.

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

  2. Depressive symptoms

    Depressive symptoms will be defined using the survey entitled, "Edinburgh Postnatal Depression Scores." This survey uses a four-point scale for each response, with higher cumulative scores corresponding to worse outcomes.

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2024 (actual). Primary completion is estimated for Dec 2026, 35 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2023
First posted
Dec 27, 2023
StartActual
Jan 1, 2024
Primary completionEst.
Dec 1, 2026
CompletionEst.
Dec 1, 2026
Last update
Apr 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06182878
Lead sponsor
Walter Reed National Military Medical Center
Responsible party
Sponsor
First posted
Dec 27, 2023
Start date
Jan 1, 2024
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Apr 22, 2026

Study contacts

David Boedeker, DO
Contact
david.h.boedeker.mil@health.mil
301-400-2140
Kiley Hunkler, MD
Contact
kiley.f.hunkler.mil@health.mil
301-400-2140
David Boedeker, DO
principal investigator · Walter Reed National Military Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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