In the present trial the effects of HRV biofeedback in patients with preterm labour were studied.

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1 PLEASE NOTE: This trial has been registered retrospectively. Trial Description Title The administration of biofeedback in patients with preterm labour Trial Acronym HRV biofeedback in preterm labour URL of the trial [---]* Brief Summary in Lay Language In the present trial the effects of HRV biofeedback in patients with preterm labour were studied. Brief Summary in Scientific Language Preterm birth is a highly prevalent phenomenon that was shown to be associated with mental stress during pregnancy. We aimed to assess the effects of heart rate variability (HRV)-biofeedback in patients with preterm labour. An experimental group consisting of 24 pregnant patients with preterm labour prior to the 37th gestational week aged between 18 and 45 years received 30 minute biofeedback training three times a week over two weeks. Heart rate variability was measured simultaneously with training, and values were compared to those of a control group obained at identical time points. Another measurement was taken 4 weeks after completion of biodfeedback. Symptoms of depression and anxiety were assessed by means of standardised questionnairs for self rating such as the State Trait Anxiety Inventory, Brief Symptom Inventory, Trier inventory for the Assessment of Chronic Stress. Organizational Data DRKS-ID: DRKS Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: EK , Ethikkommission der Medizinischen Fakultät der Technischen Universität Page 1 of 5

2 Secondary IDs Health condition or Problem studied ICD10: O Preterm labour without delivery Interventions/Observational Groups Arm 1: 6 sessions of 30 minute HRV- biofeedback training over two weeks Arm 2: 6 sessions of a 30 minute control condition (visualization of HRV without training) over two weeks Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: Open (masking not used) Who is blinded: [---]* Control: Active control Purpose: Basic research/physiological study Assignment: Parallel Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Primary Outcome Root mean square of successive differences of RR intervals (RMSSD) prior and post HRV biofeedback as well as 4 weeks later (follow up) by means of pulse wave analysis Secondary Outcome gestational duration, psychometric variables (State Trait Anxiety Inventory, Brief Symptom Inventory, Trier Inventory for the Assessment of Chronic Stress) prior and post and 4 weeks after termination of HRV biofeedback Countries of recruitment Page 2 of 5

3 DE Locations of Recruitment University Medical Center Klinik für Psychotherapie und Psychosomatik, Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2006/10/20 Target Sample Size: 48 Monocenter/Multicenter trial: Monocenter trial National/International: National Inclusion Criteria Gender: Female Minimum Age: 18 Years Maximum Age: 45 Years Additional Inclusion Criteria Pregnant women aged 18 to 45 years between gestational weeks 24 to 32 will be amitted to the study after having given oral and written informed consent. The patients should have an enhanced risk for preterm birth. Exclusion criteria Treatment with tricyclic antidepressants or beta blockers within 14 days prior to start of the study; diabetis mellitus; coronary artery disease; heart failure; preeclampsia;hellp syndrome. Addresses Primary Sponsor Page 3 of 5

4 Primary Sponsor Contact for Scientific Queries Contact for Public Queries Collaborator, Other Address Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum der TU Ms. Dr. Katharina Nitzsche Page 4 of 5

5 Collaborator, Other Address Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum der TU Ms. Dr. Katharina Nitzsche Telephone: Fax: katharina.nitzsche at uniklinikum-dresden Sources of Monetary or Material Support Institutional budget, no external funding (budget of sponsor/pi) Medizinische Fakultät der TU Mr. Prof. Dr. Martin Siepmann Telephone: [---]* Fax: [---]* [---]* Status Recruitment Status: Recruiting complete, follow-up complete Study Closing (LPLV): 2009/10/28 Trial Publications, Results and other documents * This entry means the parameter is not applicable or has not been set. Page 5 of 5