Affiliations:

1.  Rabin Medical Center

2. Tel Aviv University

Objective

This randomized controlled study evaluates whether pre-labor visual biofeedback, using Pulsenmore’s self-operated home ultrasound device, can improve maternal labor outcomes.

Here we demonstrate insights from three years of research and real-world application

Method

Nulliparous women at 37–41 weeks’ gestation planning vaginal delivery were randomized into three groups: Group 1 received routine obstetric ultrasound + biofeedback guided by an obstetrician. Group 2 received the same, plus a home ultrasound device for practice. The control group underwent routine ultrasound without biofeedback. The self-operated ultrasound device, connected to a smartphone, provided real-time visual biofeedback of fetal head descent via angle of progression (AoP). Participants in the biofeedback groups were taught to recognize landmarks and visualize AoP during coached pushing. Pushing efforts were recorded, and participants completed psychological assessments pre- and post-intervention.  

The Primary outcome was second stage duration, with secondary outcomes including psychological characteristics, mode of delivery, perineal tears, and neonatal complications. 

Results

Ninety participants were recruited and randomized. After exclusions of participants who didn’t reach full dilation or didn’t complete training, 71 were analyzed. The mean number of home training sessions was 3.5 times per participant, all successfully demonstrating the symphysis pubis and fetal head, allowing to evaluate AoP and the delta of the angles during home training. The mean ∆AoP across training sessions was 14.7°. 

When comparing maternal outcomes between the groups, the shortest second-stage labor duration was observed in the hospital + home biofeedback group (58 minutes). The hospital-only biofeedback group and the control group had a second-stage duration of 124 and 103 minutes respectively. 

The proportion of vacuum-assisted deliveries was lowest in the home biofeedback group (2/19, 10%) compared to the hospital-only biofeedback group (6/25, 24%) and the control group (5/27, 19%). 

In addition to that, participants in the home ultrasound group particularly reported feeling more in control, less anxious, and better prepared for labor.

Conclusion

These preliminary findings suggest that self-operated home ultrasound for pushing training is feasible, acceptable, and may improve labor outcomes by shortening the second stage and reducing operative delivery.

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Affiliations:

1. Division of MFM, McGovern Medical School at UTHealth, Houston, TX
2. Division of Reproductive Endocrinology & Infertility, Koc Uni. Hospital, Istanbul
3. Dept. of OBGYN, East Virginia Medical School, Norfolk, VA
4. MFM, Beth Israel Deaconess Medical Center, Boston, MA
5. Center for Fetal & Maternal Ultrasound, UCLA School of Medicine, LA, CA
6. Dept. of MFM, Brigham & Women’s Hospital, Boston, MA.
7. MFM, Icahn School of Medicine at Mount Sinai, NY
8. Pulsenmore LTD. Omer, Israel

Objective

Telehealth has become a transformative force in prenatal care, enhancing maternal satisfaction, reducing costs, and increasing efficiency without compromising safety or outcomes. The Pulsenmore home ultrasound is a handheld device connected to smartphones and guided by a mobile app, enables women to perform high-quality ultrasound scans at home. These scans are securely transmitted to clinicians, enabling a hybrid care model that combines remote monitoring with in-clinic expertise.

Here we demonstrate insights from three years of research and real-world application

Method

Clinical studies and real-world data analysis from hospitals and HMO home ultrasound services have been summarized and presented here.

Results

Several studies have validated the Pulsenmore device’s feasibility, safety, and user acceptance. A study with 100 pregnant women demonstrated its effectiveness in detecting fetal heartbeat, movement, and amniotic fluid volume (AFV), with high satisfaction. A pivotal multicenter study in the USA confirmed these results. Real-world data in Israel showed over 98% precision in detecting prenatal parameters across 170,000+ scans. In Germany, studies confirmed the device’s acceptance and image quality for assessing AFV and fetal heartbeat, showing high patient satisfaction and potential to reduce outpatient visits.

Validation studies confirmed the device’s reliability and accuracy in measuring fetal heart rate and maximal vertical pocket, as well as its capability to conduct remote Biophysical Profile tests for high-risk pregnancies.

The device’s potential was demonstrated in monitoring high-risk pregnancies, reducing anxiety and ER visits for women with previous pregnancy loss, and managing gestational diabetes. Real-world utilization data indicate successful home admission of women with high-risk pregnancies.

Conclusion

The Pulsenmore platform offers a safe, effective, and patient-centered solution for prenatal monitoring. Clinical evidence from three years of research and successful commercialization supports its integration into prenatal care.

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Presented at FIGO 2025 
https://b-com.mci-group.com/CommunityPortal/ProgressivePortal/FIGO2025/App/Views/InformationPage/View.aspx?InformationPageID=18179

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1. Helen Schneider Hospital for Women, Rabin Medical Center, Petach Tikva, Israel

2. Faculty of Health and Medicine, Tel Aviv University, Israel

Objective

This randomized controlled study evaluates the efficacy of prelabor visual biofeedback using a self-operated home ultrasound device to enhance maternal pushing and improve obstetrical outcomes.

Method

Nulliparous women at 37–41 weeks of gestation were randomized into three groups: (1) Intervention: in-hospital prelabor pushing training using trans-perineal ultrasound biofeedback, followed by self-operated home biofeedback; (2) Control: in-hospital ultrasound biofeedback training only; and (3) Routine obstetrical ultrasound.

Custom software documented pushing attempts, and sonographic analysis assessed fetal head position and offline angles of progression (AoP). Participants completed psychological assessments before and after the intervention.

The primary outcome was second stage labor duration. Secondary outcomes included pushing efficacy, mode of delivery, perineal tears, neonatal complications, and psychological factors.

Results

Seventy-two patients were randomized (24 per group). Those who did not reach full dilation or complete training were excluded. On average, participants completed 3.5 home training sessions. Mean ∆AoP was 12.3°.

The intervention group had the shortest second-stage labor duration and the lowest vacuum-assisted delivery rate compared to the control and routine care groups (63 vs. 117 vs. 101 minutes, and 1/14 [7%] vs. 4/20 [20%] vs. 5/24 [21%], respectively)

Home ultrasound participants reported greater control, reduced anxiety, and better labor preparedness.

Conclusion

Home-based ultrasound-guided prelabor pushing training is a feasible and promising approach for improving maternal birth experiences and labor outcomes.

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1. Helen Schneider Hospital for Women, Rabin Medical Center, Petah-Tikva, Israel
2. Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel
3. Dina Recanati School of Medicine, Reichman University, Herzliya, Israel
4. Translational Innovation and eHealth wing, Clalit Health Services, Tel-Aviv, Israel

OBJECTIVE

To evaluate the feasibility of performing a remote, clinician guided, biophysical profile (BPP) with execution by lay users, using a handheld portable ultrasound transducer.

DESIGN

Prospective, non-randomized, quasi-blinded clinical study. Clinician guided BPP scans made with the Pulsenmore ES device, as executed by lay-users, were compared with a conventional BPP scan adjacently performed by a healthcare professional using a standard in-clinic ultrasound device.

RESULTS

Thirty pregnant women were recruited, at mean gestational age of 33.0 ± 2.6 weeks. Mean maternal age was 31.4±4.51 years, and mean body mass index was 27.4±5.24 kg/m², with 30% classified as obese. Agreement between the BPP score obtained by the Pulsenmore ES and the in-clinic scans was 90%. Agreement for cardiac activity detection, fetal movements, fetal presentation, placental location, and subjective amniotic fluid volume was 100%. Agreement for fetal tone and breathing movement was 96.7% and 93.3%, respectively. Sensitivity and specificity of Pulsenmore ES BPP score were 92.6% and 66.7% respectively, with a mean BPP score difference of 0.07±0.64 points. Fetal heart rate and maximal vertical pocket values measured in both modalities were similar with an average difference of 6.9±4.99 Beats-Per-Minute (4.8±3.56%) and 0.85±0.72 cm (18.1±15.37%), respectively. The average duration for remote BPP was 8.0±3.94 minutes, longer than in-clinic scans (4.6±3.33 minutes) but well within the 20-minute test limit.

CONCLUSIONS

BPP, obtained by the Pulsenmore ES ultrasound device, operated by lay users, during synchronized telehealth guidance, demonstrates high accuracy and reliability for clinical use compared to standard BPP.

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1. Rabin Medical Center, Petah Tikva, Israel.
2 Pulsenmore Ltd., Israel.
3 Pulsenmore, United Kingdom

Telehealth has become a transformative force in prenatal care, enhancing maternal satisfaction, reducing costs, and increasing efficiency without compromising safety or outcomes. The Pulsenmore home ultrasound is a handheld device connected to smartphones and guided by a mobile app, enables women to perform high-quality ultrasound scans at home. These scans are securely transmitted to clinicians, enabling a hybrid care model that combines remote monitoring with in-clinic expertise. Several studies have validated the Pulsenmore device’s feasibility, safety, and user acceptance:

Clinical evidence

A study with 100 pregnant women demonstrated its effectiveness in detecting fetal heartbeat, movement, and amniotic fluid volume (AFV), with high satisfaction . A pivotal multicenter study in the USA confirmed these results. Real-world data in Israel showed over 98% precision in detecting prenatal parameters across 150,000+ scans.

In Germany, studies confirmed the device’s acceptance and image quality for assessing AFV and fetal heartbeat, showing high patient satisfaction and potential to reduce outpatient visits .

Validation studies confirmed the device’s reliability and accuracy in measuring fetal heart rate and maximal vertical pocket , as well as its capability to conduct remote Biophysical Profile tests for high-risk pregnancies.

The device’s potential was demonstrated in monitoring high-risk pregnancies, reducing anxiety and ER visits for women with previous pregnancy loss , and managing gestational diabetes . Real-world utilization data indicate successful home admission of women with high-risk pregnancies.

Conclusion:

The Pulsenmore platform offers a safe, effective, and patient-centered solution for prenatal monitoring. Clinical evidence from three years of research and successful commercialization supports its integration into prenatal care.

The post Transforming obstetric care – The impact of patient-operated home ultrasound and remote diagnosis in hybrid prenatal care: Clinical insights from three years of research and real-world application appeared first on PULSENMORE | Home Ultrasound.

Institute of Applied Health Research, University of Birmingham
Birmingham Women’s and Children’s NHS Foundation Trust

Introduction

• High-risk pregnancies will undergo regular antenatal cardiotocography (CTG) and ultrasound (USS).
• This can become a psychological expense to women, whilst creating a capacity issue within obstetric services.
• Recently there has been an emergence of sophisticated remote telehealth interventions.
• Our aim was to evaluate the feasibility home CTG and home USS monitoring for high-risk pregnancies.
• Participants continued their routine antenatal care alongside remote device usage.
  

Methods

• This was a single center feasibility study.
• Women aged ≥18 years, English speaking, singleton pregnancy, ≥32 weeks gestation and had at least one of four high-risk obstetric conditions were eligible for recruitment.
• Participants were randomised to one of three groups: (1) home USS; (2) home CTG; and (3) both (Figure 1). Images/recordings were uploaded for remote review.
• Primary outcome: completion of 20 minutes of interpretable fetal heart recording and/or completion of an interpretable fetal USS for each
  monitoring episode.
• USS interpretability was assessed for three validated criteria: fetal heartbeat, fetal movements and liquor volume assessment.
• Secondary outcomes: monitoring adherence, anxiety management, acceptability and safety.
  

Results

• 15 participants completed 59 remote CTGs and 24 remote USS.
• 75% of all CTGs contained at least 20 minutes of continuous interpretable computerised fetal heartrate recording (Figure 2).
• Overall, the fetal heartbeat, movements and liquor volume assessment were identified in 92%, 83% and 100% of all USS respectively (Figure 3).
• 79% of all scans had all three criteria unanimously assessed.
• Neither ethnicity, parity, BMI nor fetal presentation were significant factors for achievement of the primary outcome within both devices.
• There was non-significant reduction in anxiety scores before and following device usage (p=0.19) (Figure 4). Participants’ monitoring adherence and acceptability ratings were high in all groups.
• 8 CTG episodes required referral into hospital for assessment.
• No adverse maternal-fetal outcomes occurred.
  

Conclusion

• Home ultrasound and CTG are potentially feasible and acceptable to high-risk pregnant women.
• Larger studies are required to refine how best to implement such devices within clinical practice.
• To our knowledge, this is the first feasibility study to combine the use of both remote technologies.
  

https://www.obstetrics-gynaecology-journal.com/article/S1751-7214(25)00106-X/abstract

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Principal investigator, Rabin Medical Center, affiliated to the Tel-Aviv University

Natav Hendin, MD

Principal investigator Rabin Medical Center, affiliated to the Tel-Aviv University

OBJECTIVE

Remote healthcare technology offers innovative solutions for patient care and education. This randomized controlled study evaluates the efficacy of pre-labor visual biofeedback, facilitated by self-operated home ultrasound devices, in improving maternal and neonatal outcomes. 

METHOD

Nulliparous women at 37-39 weeks’ gestation planning vaginal delivery will be randomized into three groups: (1) a single in-hospital prelabor maternal pushing training session using transperineal ultrasound visual biofeedback, followed by two weeks of biofeedback with a self-operated home ultrasound device; (2) a single in-hospital prelabor training session with ultrasound visual biofeedback; and (3) routine obstetrical ultrasound without biofeedback.
The self-operated ultrasound device, connected to a smartphone, enables self-trans perineal visual biofeedback. Custom software was developed to record and review pushing practices. Sonographic analysis will include fetal biometry, fetal head position, and AoPs and HPDs during training. 
The primary outcome is the second-stage duration. Secondary outcomes include mode of delivery, maternal and neonatal adverse obstetrical outcomes. Psychological questionnaires will assess fear of childbirth, confidence, perceived control, satisfaction, post-traumatic stress symptoms, and maternal-infant bonding.

RESULTS

Sixty participants have been recruited, and enrollment is ongoing. All participants in the intervention group successfully performed effective home training. Preliminary feedback demonstrates positive experiences and increased empowerment.

COMMENTS

This study demonstrates the potential of integrating remote healthcare technologies into prenatal care through self-operated ultrasound devices. 

CONCLUSIONS

Prelabor-pushing training with self-operated ultrasound devices is feasible and promising for improving birth experiences and maternal mental health. Ongoing recruitment will provide further insights into its impact on maternal and neonatal outcomes.

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