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The incidence of postpartum depression in Europe and the United States is about 10%, while in China the incidence rate of 15.7-39.8%. Postpartum depression is one of the most common diseases of perinatal distress, but the current research of high-quality prevention and treatment of postpartum depression is still very lack. The study suggests that the risk of postpartum depression in cesarean delivery is significantly higher than that in vaginal delivery. Therefore, postpartum depression in cesarean delivery may require more attention and treatment.Tramadol is a non-opioid central analgesic that relieves common to severe pain, and tramadol has an inhibitory effect on norepinephrine and serotonin systems and has the potential to reduce depression and anxiety. Therefore, for the analgesic demand and antidepressant demand for maternal who undergoing cesarean section, tramadol may be an optimized and effective analgesic for the prevention and treatment of postpartum depression.
This study was designed according to a prospective, randomized, controlled clinical trial. Randomized subjects were randomly assigned to different analgesic drug-treated groups according to the random number induced by SPSS software. All three analgesic treatments were routinely used for clinical analgesia; Anesthesia, surgery, postoperative treatment are in accordance with clinical practice. The investigators conducted a postoperative questionnaire survey and psychological diagnosis for all patients. And blood sample was collected from patients before and 48 hours after the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group T | Active Comparator | All patients receive the patient-controlled intravenous analgesia with Tramadol. |
|
| Group H | Placebo Comparator | All patients receive the patient-controlled intravenous analgesia with Hydromorphone. |
|
| Group E | Placebo Comparator | All patients receive the patient-controlled epidural analgesia with Ropivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol | Drug | Patient-controlled intravenous analgesia with Tramadol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postpartum depression | Diagnosed according to DSM-5 diagnostic criteria for postnatal depression | At 4 weeks after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postpartum depression | Diagnosed according to DSM-5 diagnostic criteria for postnatal depression | At 3 months after the surgery |
| EPDS scores | Measured using Edinburgh Postnatal Depression Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Early walking time | The time for patient to independently activity | During hospitalization, an average of 36 hours |
| Hospital stays | The time for patient to stay in hospital after the surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Li, M.D. | Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinqiao Hospital, Third Military Medical University | Chongqing | Chongqing Municipality | 400037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34124111 | Derived | Wu Z, Zhao P, Peng J, Fang L, Ding J, Yan G, Wang Y, Zhu J, Wang D, Li Y, Chen Z, Zhang Q, Deng Q, Duan G, Zuo Z, Li H. A Patient-Controlled Intravenous Analgesia With Tramadol Ameliorates Postpartum Depression in High-Risk Woman After Cesarean Section: A Randomized Controlled Trial. Front Med (Lausanne). 2021 May 27;8:679159. doi: 10.3389/fmed.2021.679159. eCollection 2021. | |
| 30344172 |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| D004091 | Hydromorphone |
| D000077212 | Ropivacaine |
| D015360 | Analgesia, Epidural |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Hydromorphone |
| Drug |
Patient-controlled intravenous analgesia with Hydromorphone |
|
| Ropivacaine (Epidural analgesia) | Drug | Patient-controlled epidural analgesia with Ropivacaine. |
|
| At 4 weeks and 3 months after the surgery |
| GAD-7 scores | Measured using Generalized Anxiety Disorder Scale | At 4 weeks and 3 months after the surgery |
| QoR-15 scores | Measured using Quality of recovery 15 | 48 hours after the surgery |
| Pain intensity | Pain VAS at 6, 12, 24 and 48 hours after the surgery | At 6, 12, 24 and 48 hours after the surgery |
| Norepinephrine and serotonin levels in the blood | Norepinephrine and serotonin concentration in the blood at 48 hours after the surgery | At 48 hours after the surgery |
| During hospitalization, an average of 72 hours |
| Pain intensity | Postoperative pain intensity that evaluated by questionnaire at 3 months after the surgery | At 3 months after the surgery |
| Derived |
| Duan G, Wu Z, Zhao P, Peng J, Chen Z, Zhang Q, Xu R, Li H. Protocol for a randomised, double-blind, placebo-controlled trial to explore the effect of tramadol in the prevention of postpartum depression (ETPPD). BMJ Open. 2018 Oct 21;8(10):e022538. doi: 10.1136/bmjopen-2018-022538. |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |