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Biweekly Follow-Up and At-Home Ultrasound Reduce Anxiety in Women With Recurrent Pregnancy Loss

NCT05656846 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-03-22

No results posted yet for this study

Summary

Spontaneous pregnancy loss is a relatively common phenomenon, with 10-15% of clinically recognized pregnancies ending in miscarriage.1 Recurrent pregnancy loss (RPL) is a disorder defined by two or more failed pregnancies2. According to various studies, pregnancy loss has been described as a traumatic event for couples even if the loss occurs at a very early stage of pregnancy.

Few controlled studies dealt with the effects of the miscarriage on the psychological condition of women during a subsequent pregnancy, 4,6-8.

This study aimed to evaluate the effectiveness of "at home ultrasound" in addition to routine prenatal care in reducing maternal anxiety during pregnancy for patients with history of recurrent pregnancy loss.

i. Inclusion criteria:

1. Patients with recurrent pregnancy losses in first trimester
2. Current pregnancy gestational age 12-14 week of gestation
3. Singleton pregnancy ii. Exclusion criteria:

1\. Female subjects who refuse to participate 2. Female subjects who don't speak Hebrew

Device details:

Pulsenmore Specifications:

Compatible with: Android mobile phones with USB type C connector (Samsung S8+, Nokia 8, Nokia 7.1) ApplicatThe aim of this study is to evaluate the effectiveness of "at home ultrasound" in addition to routine prenatal care in reducing maternal anxiety during pregnancy for patients with history of recurrent pregnancy loss.ion: PulseNmore ES™, downloadable from Google Play™ Store.

Conditions

  • Recurrent Pregnancy Loss

Interventions

DEVICE

PulseNmore ES™

The patients will be instructed on the mode of operation of home ultrasound device (pulsenmore), the frequency and means of communication with the study team.

DEVICE

Standard Ultrasound

These patients will not receive the additional intervention and will use the Standard Ultrasound. A population of patients between 12 and 22 weeks of gestation with history of recurrent pregnancy losses who will be subjected to routine antenatal care as per clinic protocol. These patients will not receive the additional intervention.

Sponsors & Collaborators

  • Wolfson Medical Center

    lead OTHER_GOV

Principal Investigators

  • Michal Levi, Dr. · Wolfson Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2024-12-23
Completion
2025-04-01

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05656846 on ClinicalTrials.gov