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This study aims to provide evidence concerning the safety and efficacy of motherwort injection in real-world settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The assessment of treatment satisfaction. | A four-level rating scale was employed, as follows: 0 = dissatisfied; 1 = neutral; 2 = somewhat satisfied; 3 = very satisfied. | From the initiation of medication to 7 days after cessation. |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhong Wang | Contact | 13601315446 | zhonw@vip.sina.com |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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whole blood
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| The menstrual adjustment. | Ovulatory dysfunction-related abnormal uterine bleeding: utilizing a treatment satisfaction assessment (0 = dissatisfied; 1 = neutral; 2 = somewhat satisfied; 3 = very satisfied). | 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. | 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. | From the the postpartum to the end of bleeding event, assessed up to 1 year. |