NCT03309163

Effect of Tramadol in Prevention of Postpartum Depression

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,230 (actual)
• Sponsor: Xinqiao Hospital of Chongqing · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Caesarean Section

Interventions

Type	Name	Description
DRUG	Tramadol	Patient-controlled intravenous analgesia with Tramadol
DRUG	Hydromorphone	Patient-controlled intravenous analgesia with Hydromorphone
DRUG	Ropivacaine (Epidural analgesia)	Patient-controlled epidural analgesia with Ropivacaine.

Timeline

• Start date: 2017-10-09
• Primary completion: 2019-06-13
• Completion: 2019-08-13
• First posted: 2017-10-13
• Last updated: 2019-08-14

Locations

1 site across 1 country: China