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

NCT05656846 | Unknown

• 1 other identifier: WOMC-0130-22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Recurrent Pregnancy Loss

Outcome Measures

Primary Outcomes (1)

• Anxiety levels

  The delta between The State-Trait Anxiety Inventory (STAI:Y-1) score filled at recruitment and at 20-22 weeks of gestation (when patient start fill fetal movements).

  10 weeks

Study Arms (2)

Experimental: PulseNmore ES™

EXPERIMENTAL

Experimental: PulseNmore ES™: The study population will be recruited between 12 and 14 weeks of gestation. These patients will be followed using a twice weekly virtual visit by a member of the study team. This visit will include a short survey of obstetrical complaints such as contractions leakage of fluid and decreased fetal movements, as well as a brief sonographic survey using the portable ultrasound device.

Device: PulseNmore ES™

Control Standard Ultrasound

ACTIVE COMPARATOR

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.

Device: Standard Ultrasound

Interventions

PulseNmore ES™ DEVICE

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.

Experimental: PulseNmore ES™

Standard Ultrasound DEVICE

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.

Control Standard Ultrasound

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with recurrent pregnancy losses in first trimester
• Current pregnancy gestational age 12-14 week of gestation
• Singleton pregnancy

You may not qualify if:

• Female subjects who refuse to participate
• Female subjects who don't speak Hebrew

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Departments of Obstetrics & Gynecology, affiliated with Sackler Faculty of Medicine, Tel Aviv University

Holon, 6404519, Israel

RECRUITING

Related Publications (8)

• Macklon NS, Geraedts JP, Fauser BC. Conception to ongoing pregnancy: the 'black box' of early pregnancy loss. Hum Reprod Update. 2002 Jul-Aug;8(4):333-43. doi: 10.1093/humupd/8.4.333.

  PMID: 12206468 BACKGROUND

• Practice Committee of the American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss: a committee opinion. Fertil Steril. 2013 Jan;99(1):63. doi: 10.1016/j.fertnstert.2012.09.023. Epub 2012 Oct 22.

  PMID: 23095139 BACKGROUND

• Lee C, Slade P. Miscarriage as a traumatic event: a review of the literature and new implications for intervention. J Psychosom Res. 1996 Mar;40(3):235-44. doi: 10.1016/0022-3999(95)00579-x.

  PMID: 8861119 BACKGROUND

• Bergner A, Beyer R, Klapp BF, Rauchfuss M. Pregnancy after early pregnancy loss: a prospective study of anxiety, depressive symptomatology and coping. J Psychosom Obstet Gynaecol. 2008 Jun;29(2):105-13. doi: 10.1080/01674820701687521.

  PMID: 17943588 BACKGROUND

• Lee C, Slade P, Lygo V. The influence of psychological debriefing on emotional adaptation in women following early miscarriage: a preliminary study. Br J Med Psychol. 1996 Mar;69(1):47-58. doi: 10.1111/j.2044-8341.1996.tb01849.x.

  PMID: 8829399 BACKGROUND

• Woods-Giscombe CL, Lobel M, Crandell JL. The impact of miscarriage and parity on patterns of maternal distress in pregnancy. Res Nurs Health. 2010 Aug;33(4):316-28. doi: 10.1002/nur.20389.

  PMID: 20544819 BACKGROUND

• Tsartsara E, Johnson MP. The impact of miscarriage on women's pregnancy-specific anxiety and feelings of prenatal maternal-fetal attachment during the course of a subsequent pregnancy: an exploratory follow-up study. J Psychosom Obstet Gynaecol. 2006 Sep;27(3):173-82. doi: 10.1080/01674820600646198.

  PMID: 17214452 BACKGROUND

• Hada K, Kuse E, Nakatsuka M. Women with Recurrent Pregnancy Loss : Their Psychology During Late Pregnancy and the Supportive Behavior of Their Partners. Acta Med Okayama. 2018 Aug;72(4):387-394. doi: 10.18926/AMO/56176.

  PMID: 30140087 BACKGROUND

Study Officials

• Michal Levi, Dr.

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Levi, Dr.

CONTACT

0528591994; levmichal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1. Recruitment of eligible patients. Patients will receive an explanation of the study protocol, purpose and methodology including the difference between the two study groups. Willing participants will sign an informed consent. 2. Initiation visit, the patient will be randomly assigned to one of the 2 study groups. 3. Following the random assignment, all participants will complete 3 validated questionnaires. Addendum 1. Questionnaire: Maternal Antenatal Attachment Scale-MAAS (female) Addendum 2. Revised Prenatal Distress Questionnaire. Addendum 3. After completion of the questionnaires, patients will be instructed on the mode of operation of home ultrasound device (pulsenmore), the frequency and means of communication with the study team. 4. At 20-22 weeks of gestation, completion of the three questionnaires. 5. Collected data 1. Demographic characteristics 2. Antenatal follow-up 3. Results of the various questionnaires

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: December 19, 2022
• Study Start: July 15, 2022
• Primary Completion: December 23, 2024
• Study Completion: April 1, 2025
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

IL (1)