Tender Loving Care for Recurrent Pregnancy Loss | NCT06182878

Studies
Tender Loving Care for Recurrent Pregnancy Loss

NCT06182878

Sponsor

Walter Reed National Military Medical Center

Status

Recruiting

Last Update Posted

Apr 22, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Recurrent Pregnancy Loss

Interventions

Tender loving care intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Nov 28, 2023

First Submission Date that Met QC Criteria

Dec 13, 2023

First Posted Date

Dec 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2026

Last Update Posted Date

Apr 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tender loving care intervention	Experimental	Weekly prenatal counseling messages sent via an online platform.	Behavioral: Tender loving care intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tender loving care intervention	Behavioral	Receiving weekly prenatal care counseling messages	Tender loving care intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	Baseline at enrollment of study, repeat assessments at 13 weeks, 28 weeks, and 6 weeks after delivery or after miscarriage

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
David Boedeker, DO	Walter Reed National Military Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Walter Reed National Military Medical Center	Recruiting	Bethesda	Maryland	20814	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided