Informative Video Before LMWH Postpartum - Randomized Controlled Trial

NCT07168005 | Not Yet Recruiting

• 1 other identifier: 0121-25-WOMC
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center randomized controlled trial evaluates whether a short informative video can reduce anxiety and pain before the first postpartum administration of low molecular weight heparin (LMWH, Clexane). Eligible women will be randomized to receive either standard explanation alone or standard explanation plus a short educational video. The primary outcome is anxiety level assessed via the State-Trait Anxiety Inventory (STAI). Secondary outcomes include pain, satisfaction, and treatment adherence.

Conditions

Venous Thromboembolism (VTE); Postpartum Care; Anxiety

Keywords

Postpartum; Venous Thromboembolism; VTE; LMWH; Low Molecular Weight Heparin; Clexane; Anxiety; Pain; Patient Education; Informative Video; State-Trait Anxiety Inventory; STAI; Postpartum Care; Women's Health; Obstetrics; Adherence

Outcome Measures

Primary Outcomes (1)

• Post-intervention Anxiety Level (STAI Score)

  Anxiety will be measured using the State-Trait Anxiety Inventory (STAI) after participants receive either the standard explanation alone or view informative video, and before their first LMWH (Clexane) injection.

  Immediately after intervention and before first LMWH injection

Secondary Outcomes (4)

• Change in Anxiety Level (Δ STAI Score)

  From baseline (before intervention) to immediately after intervention (within 1 hour postpartum)

• Pain and Discomfort During Injection (VAS Score)

  Immediately after the first LMWH injection

• Satisfaction With Explanation Process (VAS Score)

  Immediately after the intervention and first injection

• Adherence to LMWH at Home

  Up to 6 weeks post-discharge

Study Arms (2)

Video

EXPERIMENTAL

Participants in this group will view a short (up to 5 minutes) informative video. The video explains the rationale, procedure, and safety of LMWH to reduce anxiety and increase patient understanding prior to the first injection.

Behavioral: Informative Video on LMWH

Control Group

ACTIVE COMPARATOR

Participants in this group will receive only a verbal explanation regarding postpartum LMWH (Clexane) administration, without any additional video intervention. This represents the current standard of care

Behavioral: Standard Verbal Explanation

Interventions

Informative Video on LMWH BEHAVIORAL

A short (up to 5 minutes) informative video presented to postpartum women prior to their first LMWH (Clexane) injection. The video explains the rationale, process, and safety of LMWH use for thrombopr

Video

Standard Verbal Explanation BEHAVIORAL

Participants receive the routine verbal explanation regarding postpartum LMWH (Clexane) administration, covering its purpose and method of injection

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women 18-45 years, postpartum, indicated for LMWH, Hebrew-literate, gave consent

You may not qualify if:

• Use of LMWH pre-delivery, IUFD, pregnancy termination, language/cognitive barrier

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson Medical Center

Holon, Israel

Location

Related Publications (5)

• MacLean S, Mulla S, Akl EA, Jankowski M, Vandvik PO, Ebrahim S, McLeod S, Bhatnagar N, Guyatt GH. Patient values and preferences in decision making for antithrombotic therapy: a systematic review: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e1S-e23S. doi: 10.1378/chest.11-2290.

  PMID: 22315262 BACKGROUND

• Wong AKC, Chu RYK, Nan Y, Cheng H, Tong D, Leung M, Lam H, Chiu SH, Cheung HW, Chan MC, Chau MY, Lee T, Leung YW, Mow HC, Wan S, Wong LY, Montarye J. Injection Techniques to Reduce Adverse Effects of Subcutaneous Low-Molecular-Weight Heparin Among Patients With Cardiovascular Diseases: A Scoping Review. J Adv Nurs. 2025 Nov;81(11):7361-7373. doi: 10.1111/jan.16475. Epub 2024 Sep 25.

  PMID: 39323021 BACKGROUND

• Middeldorp S, Ganzevoort W. How I treat venous thromboembolism in pregnancy. Blood. 2020 Nov 5;136(19):2133-2142. doi: 10.1182/blood.2019000963.

  PMID: 32797192 BACKGROUND

• James AH. Prevention and management of venous thromboembolism in pregnancy. Am J Med. 2007 Oct;120(10 Suppl 2):S26-34. doi: 10.1016/j.amjmed.2007.08.011.

  PMID: 17916457 BACKGROUND

• Bates SM, Rajasekhar A, Middeldorp S, McLintock C, Rodger MA, James AH, Vazquez SR, Greer IA, Riva JJ, Bhatt M, Schwab N, Barrett D, LaHaye A, Rochwerg B. American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy. Blood Adv. 2018 Nov 27;2(22):3317-3359. doi: 10.1182/bloodadvances.2018024802.

  PMID: 30482767 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matan Friedman, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

• Amihai Rottenstreich, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matan Friedman, MD

CONTACT

+972 54-421-0360; matan.friedman@gmail.com

Amihai Rottenstreich, MD

CONTACT

+972 50-688-4171; amichaimd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Neither participants nor healthcare providers are blinded to group allocation, as the nature of the intervention (informative video) makes blinding infeasible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the intervention group (standard explanation plus a short informative video) or the control group (standard explanation only). Both groups will receive their assigned explanation prior to the first postpartum LMWH (Clexane) injection. Outcomes will be assessed immediately following the intervention.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 11, 2025
• Study Start: October 15, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): October 15, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start Date: 6 months after publication of the primary results. End Date: 5 years after publication.
• Access Criteria: De-identified individual participant data (IPD) and supporting documents (study protocol, statistical analysis plan, informed consent form) will be made available to qualified researchers affiliated with academic or healthcare institutions. Access will be granted upon reasonable request, subject to approval by the principal investigator and the Edith Wolfson Medical Center institutional review board. Approved data will be shared through a secure institutional file transfer system.

Locations

IL (1)