Tender Loving Care for Recurrent Pregnancy Loss
ConditionRecurrent Pregnancy Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorWalter Reed National Military Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Tender loving care intervention
BehavioralReceiving weekly prenatal care counseling messages
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Tender loving care interventionExperimental treatment 1 intervention
Trial outcomes
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 yearSecondary 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 miscarriage2
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov