Post-marketing Safety and Efficacy Surveillance of Motherwort Injection

NCT06636422 | Not Yet Recruiting DMC

• 1 other identifier: Motherwort-V2.0
• Study Type: observational
• Target: 20,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to provide evidence concerning the safety and efficacy of motherwort injection in real-world settings.

Conditions

Bleeding; Real-world Study; Adverse Events

Keywords

Adverse events; Motherwort injection; bleeding; real-world study; Post-abortion hemorrhage; Uterine retraction

Outcome Measures

Primary Outcomes (5)

• The type and incidence of adverse events.

  From the initiation of medication to 7 days after cessation.

• Bleeding control.

  Including:1. Hysteroscopic surgery: the intraoperative blood loss, the postoperative blood loss, the cumulative bleeding time. 2.Uterine fibroid resection: the intraoperative blood loss, the postoperative blood loss, the cumulative bleeding time.

  From the commencement of the surgery to the end of bleeding event, assessed up to 1 year.

• The incidence of postpartum hemorrhage.

  Postpartum hemorrhage is defined as a blood loss of ≥500 ml following vaginal delivery or ≥1000 ml following cesarean delivery, or the presence of symptoms or signs of hypovolemia associated with blood loss within 24 hours .

  From the completion of the surgery to 24 hours following the delivery of the fetus.

• The post-abortion recovery.

  The interval time to the resumption of menstruation post-surgery.

  From the completion of the abortion to the subsequent onset of menstruation, assessed up to 1 year.

• The incidence of post-abortion bleeding.

  The cumulative days of postoperative bleeding.

  From the completion of the abortion to the end of bleeding event.

Secondary Outcomes (4)

• The types and incidence of adverse reactions.

  From the initiation of medication to 7 days after cessation.

• Analysis of factors associated with adverse reactions.

  From the initiation of medication to 7 days after cessation.

• The menstrual adjustment.

  From the initiation of medication to menstruation returns to normal or the treatment is completed, whichever came first, assessed up to 1 year.

• The uterine retraction status.

  From the the postpartum to the end of bleeding event, assessed up to 1 year.

Other Outcomes (1)

• The assessment of treatment satisfaction.

  From the initiation of medication to 7 days after cessation.

Study Arms (1)

Patients indicated for Motherwort injection

During the registration and enrollment period of the study, all patients who meet the clinical indications for the use of motherwort injection, as determined by the physician, and voluntarily agree to participate while fulfilling ethical requirements, will be recruited from designated medical institutions and departments. The observation period for each observer was established based on the clinical application of motherwort injection.

Drug: Motherwort injection

Interventions

Motherwort injection DRUG

Patients will be given motherwort injection according to their disease condition in the real world. The investigator only can record the information on the usage of the drug and the relevant medications without any interventions.

Also known as: Yimucao Injection

Patients indicated for Motherwort injection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from designated medical institutions (departments) who meet the clinical indications for the use of motherwort injection as determined by a physician, voluntarily participate in this study, and fulfill ethical requirements.

You may qualify if:

• Meet the clinical indications for the use of motherwort injection
• Voluntarily participate in this study
• Fulfill ethical requirements.

You may not qualify if:

• None

Sponsors & Collaborators

• Zhong Wang: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhong Wang

CONTACT

13601315446; zhonw@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 10, 2024
• Study Start: October 15, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-03