Effect of Tramadol in Prevention of Postpartum Depression

NCT03309163 | Completed Phase 4 DMC

• 1 other identifier: ETPPD Trail
• Study Type: interventional
• Target: 1,230
• Locations: 1 country
• Sites: 1

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.

Conditions

Caesarean Section

Outcome Measures

Primary Outcomes (1)

• The incidence of postpartum depression

  Diagnosed according to DSM-5 diagnostic criteria for postnatal depression

  At 4 weeks after the surgery

Secondary Outcomes (6)

• The incidence of postpartum depression

  At 3 months after the surgery

• EPDS scores

  At 4 weeks and 3 months after the surgery

• GAD-7 scores

  At 4 weeks and 3 months after the surgery

• QoR-15 scores

  48 hours after the surgery

• Pain intensity

  At 6, 12, 24 and 48 hours after the surgery

Other Outcomes (3)

• Early walking time

  During hospitalization, an average of 36 hours

• Hospital stays

  During hospitalization, an average of 72 hours

• Pain intensity

  At 3 months after the surgery

Study Arms (3)

Group T

ACTIVE COMPARATOR

All patients receive the patient-controlled intravenous analgesia with Tramadol.

Drug: Tramadol

Group H

PLACEBO COMPARATOR

All patients receive the patient-controlled intravenous analgesia with Hydromorphone.

Drug: Hydromorphone

Group E

PLACEBO COMPARATOR

All patients receive the patient-controlled epidural analgesia with Ropivacaine.

Drug: Ropivacaine (Epidural analgesia)

Interventions

Tramadol DRUG

Patient-controlled intravenous analgesia with Tramadol

Group T

Hydromorphone DRUG

Patient-controlled intravenous analgesia with Hydromorphone

Group H

Ropivacaine (Epidural analgesia) DRUG

Patient-controlled epidural analgesia with Ropivacaine.

Group E

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

Study Sites (1)

Xinqiao Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400037, China

Location

Related Publications (2)

• 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.

  PMID: 34124111 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.

  PMID: 30344172 DERIVED

MeSH Terms

Interventions

Tramadol; Hydromorphone; Ropivacaine; Analgesia, Epidural

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Analgesia; Anesthesia and Analgesia

Study Officials

• Hong Li, M.D.

  Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Anesthesiology

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 13, 2017
• Study Start: October 9, 2017
• Primary Completion: June 13, 2019
• Study Completion: August 13, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

CN (1)