Status:
COMPLETED
Effect of Tramadol in Prevention of Postpartum Depression
Lead Sponsor:
Xinqiao Hospital of Chongqing
Conditions:
Caesarean Section
Eligibility:
FEMALE
20-40 years
Phase:
PHASE4
Brief 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 perina...
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...
Eligibility Criteria
Inclusion
- 20 years old ≤ age ≤ 40 years old;
- ASA score I-Ⅱ;
- uncomplicated and singleton full-term pregnancy;
- voluntarily to receive cesarean section and postoperative controlled analgesia;
- consent to participate the study.
Exclusion
- with history of mental disorders or psychotropic substances use;
- with history of neurological diseases such as epilepsy
- with history of previously known diagnosed depression;
- with suicidal ideation or history of suicide;
- with history of drug,alcohol or opioid abuse;
- with monoamine oxidase (MAO) inhibitor treatment at present or in the past 14 days;
- participating in other clinical studies
- with severe heart disease, brain disease, liver disease and kidney disease;
- be allergic to tramadol or opioids;
- with any contraindication for combined spinal epidural anesthesia;
- incapable of communication or cooperation.
Key Trial Info
Start Date :
October 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2019
Estimated Enrollment :
1230 Patients enrolled
Trial Details
Trial ID
NCT03309163
Start Date
October 9 2017
End Date
August 13 2019
Last Update
August 14 2019
Active Locations (1)
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1
Xinqiao Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China, 400037