Post-marketing Safety and Efficacy Surveillance of Motherwort Injection

Not yet recruiting

• Conditions: Bleeding; Real-world Study; Adverse Events
• Interventions: Drug: Motherwort injection

• Registration Number: NCT06636422
• Lead Sponsor: Zhong Wang

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-10
• Last Update Submitted: 2024-10-11
• Study Start: 2024-10-15
• Last Update Posted: 2024-10-15
• Primary Completion: 2025-10-15
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients indicated for Motherwort injection	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.

Primary Outcome Measures

Name	Time	Method
The type and incidence of adverse events.	From the initiation of medication to 7 days after cessation.
Bleeding control.	From the commencement of the surgery to the end of bleeding event, assessed up to 1 year.	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.
The incidence of postpartum hemorrhage.	From the completion of the surgery to 24 hours following the delivery of the fetus.	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 .
The post-abortion recovery.	From the completion of the abortion to the subsequent onset of menstruation, assessed up to 1 year.	The interval time to the resumption of menstruation post-surgery.
The incidence of post-abortion bleeding.	From the completion of the abortion to the end of bleeding event.	The cumulative days of postoperative bleeding.

Secondary Outcome Measures

Name	Time	Method
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.	Ovulatory dysfunction-related abnormal uterine bleeding: utilizing a treatment satisfaction assessment (0 = dissatisfied; 1 = neutral; 2 = somewhat satisfied; 3 = very satisfied).
The uterine retraction status.	From the the postpartum to the end of bleeding event, assessed up to 1 year.	Including:1.Rate of poor uterine involution: poor uterine involution is defined as the persistence of lochia beyond 42 days postpartum. 2. Duration of lochia cessation.
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.