Conditions

Anxiety Disorder Recurrent Pregnancy Loss Without Current Pregnancy

Keywords

recurrent pregnancy lossanxietyemotion-autonomic dysregulationdorsolateral prefrontal cortexfunctional near-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

Group-dependent hemispheric asymmetry of DLPFC activation during aversive emotional stimulation (group × hemisphere interaction)
The primary endpoint will be the group-by-hemisphere interaction in task-evoked DLPFC HbO activation during aversive emotional stimulation, comparing women with recurrent pregnancy loss (RPL) with anxiety versus without anxiety. Hemisphere will be defined as right versus left DLPFC, measured within the same participant. The participant-level activation metric will be the DLPFC HbO response estimate (β) derived from the prespecified fNIRS analysis pipeline. The primary hypothesis will be tested using a linear mixed-effects model (LME) fitted by restricted maximum likelihood, with prespecified covariates including age, education, body mass index, miscarriage etiology category, and resting heart rate. The primary confirmatory test will evaluate whether the right-minus-left difference in DLPFC activation differs by group.
Single-session fNIRS-ECG protocol (Day 1)

Secondary Outcomes (2)

Group difference in interhemispheric synchronization of DLPFC activity
Single-session fNIRS-ECG protocol (Day 1)
Group difference in mean heart-rate increase during aversive emotional stimulation
Single-session fNIRS-ECG protocol (Day 1)

Other Outcomes (3)

Support vector machine discrimination of individual joint WTC-HR response profiles in recurrent pregnancy loss with versus without anxiety
Single-session fNIRS-ECG protocol (Day 1)
Comparison of adverse events (AEs) and serious adverse events (SAEs) between groups
Single-session fNIRS-ECG protocol (Day 1)
Interhemispheric DLPFC coordination as a mediator of the association between anxiety status and task-evoked heart-rate response in recurrent pregnancy loss
Single-session fNIRS-ECG protocol (Day 1)

Study Arms (2)

Women with recurrent pregnancy loss and comorbid anxiety

Women with recurrent pregnancy loss who will meet DSM-5 criteria for a comorbid anxiety disorder. Participants in this cohort will undergo the same protocol-assigned multisensory aversive stimulation paradigm during simultaneous fNIRS and ECG recording. This cohort will be compared with women with recurrent pregnancy loss without comorbid anxiety to evaluate DLPFC activation, interhemispheric coherence, heart-rate responses, and brain-heart coupling features.

Behavioral: Multisensory aversive emotional challenge task

Women with recurrent pregnancy loss without comorbid anxiety

Women with recurrent pregnancy loss who will not meet DSM-5 criteria for a comorbid anxiety disorder. Participants in this cohort will undergo the same protocol-assigned multisensory aversive stimulation paradigm during simultaneous fNIRS and ECG recording. This cohort will serve as the comparison group for evaluating DLPFC activation, interhemispheric coherence, heart-rate responses, and brain-heart coupling features.

Behavioral: Multisensory aversive emotional challenge task

Interventions

Multisensory aversive emotional challenge taskBehavioral

Participants will undergo a standardized multisensory aversive stimulation paradigm during simultaneous fNIRS and ECG recording. The protocol will use a block design with 12 stimulation blocks, each comprising a 20 s resting phase followed by a 30 s multisensory stimulation phase. During stimulation, participants will view six negative high-arousal images per block selected from the Geneva Affective Picture Database, while concurrently being exposed to time-locked band-limited white noise calibrated to approximately 90 dB(A) and placing both hands on a 0.5 liter bottle filled with ice water maintained at approximately 0 °C. The auditory stimulus will have spectral energy restricted to 2-6 kHz. This standardized multisensory protocol will be used to elicit negative affect and sympathetic arousal.

Women with recurrent pregnancy loss and comorbid anxietyWomen with recurrent pregnancy loss without comorbid anxiety

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

Recruitment is expected to occur through obstetrics and gynecology outpatient clinics, as well as community outreach via flyers and media campaigns.

You may qualify if:

Female, age 18 to 45 years, right-handed;

Sponsors & Collaborators

Shenyang Medical College
Otherlead

Study Sites (4)

The Second Affiliated Hospital of Shenyang Medical College

Shenyang, Liaoning, 110001, China

Central Hospital Affiliated to Shenyang Medical College

Shenyang, Liaoning, 110024, China

157 Hospital of Liaoning Health Industry Group

Shenyang, Liaoning, 110045, China

242 Hospital Affiliated to Shenyang Medical College

Shenyang, Liaoning, 110086, China

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

Yun-En Liu, MD
Shenyang Medical College
STUDY CHAIR
Lin Tao, MM
Shenyang Medical College
PRINCIPAL INVESTIGATOR
Fei Meng, MD
Central Hospital Affiliated to Shenyang Medical Collage
STUDY DIRECTOR
Xiu-Ling Zhang, MD
The Second Hospital of Shenyang Medical College
STUDY DIRECTOR

Altered Interhemispheric DLPFC Coordination and Cardiac Hyperreactivity During Multisensory Aversive Challenge in Recurrent Pregnancy Loss With Comorbid Anxiety

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (3)

Study Arms (2)

Women with recurrent pregnancy loss and comorbid anxiety

Women with recurrent pregnancy loss without comorbid anxiety

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (3)

Study Arms (2)

Women with recurrent pregnancy loss and comorbid anxiety

Women with recurrent pregnancy loss without comorbid anxiety

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations