Effect of Tramadol in Prevention of Postpartum Depression

Caesarean Section Clinical Trial

— ETPPD  

Official title:

Effect of Tramadol in Prevention of Postpartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03309163
• Other study ID #: ETPPD Trail
• Status: Completed
• Phase: Phase 4
• Start date: October 9, 2017
• Est. completion date: August 13, 2019

Study information

• Verified date: August 2019
• Source: Xinqiao Hospital of Chongqing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1230
• Est. completion date: August 13, 2019
• Est. primary completion date: June 13, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• 20 years old = age = 40 years old;

• ASA score I-?;

• 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.

Related Conditions & MeSH terms

• Caesarean Section
• Depression
• Depression, Postpartum

Intervention

Drug:
• Tramadol
Patient-controlled intravenous analgesia with Tramadol
• Hydromorphone
Patient-controlled intravenous analgesia with Hydromorphone
• Ropivacaine (Epidural analgesia)
Patient-controlled epidural analgesia with Ropivacaine.

Locations

Country	Name	City	State
China	Xinqiao Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Early walking time	The time for patient to independently activity	During hospitalization, an average of 36 hours
Other	Hospital stays	The time for patient to stay in hospital after the surgery	During hospitalization, an average of 72 hours
Other	Pain intensity	Postoperative pain intensity that evaluated by questionnaire at 3 months after the surgery	At 3 months after the surgery
Primary	The incidence of postpartum depression	Diagnosed according to DSM-5 diagnostic criteria for postnatal depression	At 4 weeks after the surgery
Secondary	The incidence of postpartum depression	Diagnosed according to DSM-5 diagnostic criteria for postnatal depression	At 3 months after the surgery
Secondary	EPDS scores	Measured using Edinburgh Postnatal Depression Scale	At 4 weeks and 3 months after the surgery
Secondary	GAD-7 scores	Measured using Generalized Anxiety Disorder Scale	At 4 weeks and 3 months after the surgery
Secondary	QoR-15 scores	Measured using Quality of recovery 15	48 hours after the surgery
Secondary	Pain intensity	Pain VAS at 6, 12, 24 and 48 hours after the surgery	At 6, 12, 24 and 48 hours after the surgery
Secondary	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