Adverse Events, Bleeding, Real-world Study
Conditions
Keywords
Adverse events, Motherwort injection, bleeding, real-world study, Post-abortion hemorrhage, Uterine retraction
Brief summary
This study aims to provide evidence concerning the safety and efficacy of motherwort injection in real-world settings.
Interventions
DRUGMotherwort injection
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.
Sponsors
Zhong Wang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Meet the clinical indications for the use of motherwort injection * Voluntarily participate in this study * Fulfill ethical requirements.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of post-abortion bleeding. | From the completion of the abortion to the end of bleeding event. | The cumulative days of postoperative bleeding. |
| 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 type and incidence of adverse events. | From the initiation of medication to 7 days after cessation. | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. | Ovulatory dysfunction-related abnormal uterine bleeding: utilizing a treatment satisfaction assessment (0 = dissatisfied; 1 = neutral; 2 = somewhat satisfied; 3 = very satisfied). |
| The types and incidence of adverse reactions. | From the initiation of medication to 7 days after cessation. | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| The assessment of treatment satisfaction. | From the initiation of medication to 7 days after cessation. | A four-level rating scale was employed, as follows: 0 = dissatisfied; 1 = neutral; 2 = somewhat satisfied; 3 = very satisfied. |
Contacts
Primary ContactZhong Wang
Outcome results
None listed