Clinical trial NCT03309163: Effect of Tramadol in Prevention of Postpartum Depression
Official title: Effect of Tramadol in Prevention of Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caesarean Section
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 1230
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: The incidence of postpartum depression
timeFrame: At 4 weeks after the surgery
Secondary outcomes:
measure: The incidence of postpartum depression
timeFrame: At 3 months after the surgery
measure: EPDS scores
timeFrame: At 4 weeks and 3 months after the surgery
measure: GAD-7 scores
timeFrame: At 4 weeks and 3 months after the surgery
measure: QoR-15 scores
timeFrame: 48 hours after the surgery
measure: Pain intensity
timeFrame: At 6, 12, 24 and 48 hours after the surgery
measure: Norepinephrine and serotonin levels in the blood
timeFrame: At 48 hours after the surgery
Other outcomes:
measure: Early walking time
timeFrame: During hospitalization, an average of 36 hours
measure: Hospital stays
timeFrame: During hospitalization, an average of 72 hours
measure: Pain intensity
timeFrame: At 3 months after the surgery
Locations:
city: Chongqing
country: China
facility: Xinqiao Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University
name: Hong Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.