Tender Loving Care for Recurrent Pregnancy Loss

NCT ID: NCT06182878

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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

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Recurrent Pregnancy Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tender loving care intervention

Weekly prenatal counseling messages sent via an online platform.

Group Type EXPERIMENTAL

Tender loving care intervention

Intervention Type BEHAVIORAL

Receiving weekly prenatal care counseling messages

Interventions

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Tender loving care intervention

Receiving weekly prenatal care counseling messages

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Walter Reed National Military Medical Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Boedeker, DO

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Locations

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Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David Boedeker, DO

Role: CONTACT

301-400-2140

Kiley Hunkler, MD

Role: CONTACT

301-400-2140

Facility Contacts

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David Boedeker

Role: primary

Other Identifiers

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23-17302

Identifier Type: -

Identifier Source: org_study_id

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