Informative Video Before LMWH Postpartum - Randomized Controlled Trial

NCT ID: NCT07168005

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2027-10-15

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.

Detailed Description

Venous thromboembolism (VTE) is a leading cause of maternal morbidity and mortality, with the postpartum period carrying a particularly elevated risk. As part of standard care, low molecular weight heparin (LMWH), typically Clexane, is frequently prescribed postpartum for thromboprophylaxis. However, the initiation of LMWH injections during the early postpartum period may provoke anxiety and discomfort due to heightened pain sensitivity, unfamiliarity with the treatment, and emotional vulnerability.

While informative videos have been shown to reduce patient anxiety and increase procedural satisfaction in various medical contexts, no studies have explored their use in the postpartum setting specifically for LMWH initiation. This study aims to determine whether a brief educational video shown to women prior to their first LMWH injection postpartum can reduce anxiety and pain, improve satisfaction, and potentially enhance adherence to treatment.

This is a prospective, single-center randomized controlled trial conducted at Edith Wolfson Medical Center. Women aged 18-45 who delivered at the hospital and are indicated for LMWH will be recruited and randomized in a 1:1 ratio into two groups. The control group will receive the standard verbal explanation from nursing staff regarding LMWH administration. The intervention group will receive the same standard explanation, followed by a short (up to 5 minutes) educational video explaining the rationale, process, and safety of LMWH therapy in the postpartum period.

The primary outcome is the anxiety level measured using the State-Trait Anxiety Inventory (STAI) after receiving the explanation or video and before the first LMWH injection. Secondary outcomes include the change in anxiety (ΔSTAI) before and after the intervention, pain and discomfort measured by an 11-point Visual Analog Scale (VAS), satisfaction with the explanation process, and adherence to LMWH treatment post-discharge as assessed via telephone follow-up.

The study will enroll 160 participants to account for an estimated 30% dropout rate, based on a calculated sample size of 126 participants needed to detect a clinically significant 5-point difference in STAI scores (power 80%, α = 0.05). Randomization will be performed using sealed envelopes. Blinding is not applicable. Data will be collected via structured questionnaires administered before and after the intervention, with follow-up data obtained via phone contact for those discharged with ongoing LMWH therapy.

Ethical approval will be obtained from the institutional review board prior to recruitment. Participation is voluntary, and informed consent will be obtained from all participants. All data will be anonymized and stored securely on password-protected hospital servers. No biological samples will be collected.

This study seeks to provide evidence on the role of simple digital educational tools in improving the postpartum care experience and reducing patient distress during routine pharmacologic interventions.

Conditions

Venous Thromboembolism (VTE); Postpartum Care; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Video

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.

Group Type: EXPERIMENTAL

Informative Video on LMWH

Intervention Type: 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

Control Group

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

Group Type: ACTIVE_COMPARATOR

Standard Verbal Explanation

Intervention Type: BEHAVIORAL

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

Interventions

Informative Video on LMWH

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

Intervention Type: BEHAVIORAL

Standard Verbal Explanation

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wolfson Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matan Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson Medical Center

Amihai Rottenstreich, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson Medical Center

Locations

Wolfson Medical Center

Holon, , Israel

Countries

Israel

Central Contacts

Matan Friedman, MD

Role: CONTACT

matan.friedman@gmail.com

+972 54-421-0360

Amihai Rottenstreich, MD

Role: CONTACT

amichaimd@gmail.com

+972 50-688-4171

Facility Contacts

Matan Friedman, MD

Role: primary

matan.friedman@gmail.com

+972 54-421-0360

Hagit Eisenberg, MD

Role: backup

hagiteisen@yahoo.com

+972523397843

References

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Reference Type: BACKGROUND

PMID: 22315262 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 39323021 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 32797192 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17916457 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30482767 (View on PubMed)

Other Identifiers

0121-25-WOMC

Identifier Type: -

Identifier Source: org_study_id