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Effect of Tramadol in Prevention of Postpartum Depression (ETPPD)

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ClinicalTrials.gov Identifier: NCT03309163
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Hong Li, Xinqiao Hospital of Chongqing

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.

Condition or disease Intervention/treatment Phase
Caesarean Section Drug: Tramadol Drug: Hydromorphone Drug: Ropivacaine (Epidural analgesia) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Tramadol in Prevention of Postpartum Depression
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group T
All patients receive the patient-controlled intravenous analgesia with Tramadol.
Drug: Tramadol
Patient-controlled intravenous analgesia with Tramadol

Placebo Comparator: Group H
All patients receive the patient-controlled intravenous analgesia with Hydromorphone.
Drug: Hydromorphone
Patient-controlled intravenous analgesia with Hydromorphone

Placebo Comparator: Group E
All patients receive the patient-controlled epidural analgesia with Ropivacaine.
Drug: Ropivacaine (Epidural analgesia)
Patient-controlled epidural analgesia with Ropivacaine.




Primary Outcome Measures :
  1. The incidence of postpartum depression [ Time Frame: At 4 weeks after the surgery ]
    Diagnosed according to DSM-5 diagnostic criteria for postnatal depression


Secondary Outcome Measures :
  1. The incidence of postpartum depression [ Time Frame: At 3 months after the surgery ]
    Diagnosed according to DSM-5 diagnostic criteria for postnatal depression

  2. EPDS scores [ Time Frame: At 4 weeks and 3 months after the surgery ]
    Measured using Edinburgh Postnatal Depression Scale

  3. GAD-7 scores [ Time Frame: At 4 weeks and 3 months after the surgery ]
    Measured using Generalized Anxiety Disorder Scale

  4. QoR-15 scores [ Time Frame: 48 hours after the surgery ]
    Measured using Quality of recovery 15

  5. Pain intensity [ Time Frame: At 6, 12, 24 and 48 hours after the surgery ]
    Pain VAS at 6, 12, 24 and 48 hours after the surgery

  6. Norepinephrine and serotonin levels in the blood [ Time Frame: At 48 hours after the surgery ]
    Norepinephrine and serotonin concentration in the blood at 48 hours after the surgery


Other Outcome Measures:
  1. Early walking time [ Time Frame: During hospitalization, an average of 36 hours ]
    The time for patient to independently activity

  2. Hospital stays [ Time Frame: During hospitalization, an average of 72 hours ]
    The time for patient to stay in hospital after the surgery

  3. Pain intensity [ Time Frame: At 3 months after the surgery ]
    Postoperative pain intensity that evaluated by questionnaire at 3 months after the surgery



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309163


Contacts
Contact: Guangyou Hong, M.D. (+86)18323376014 472217836@qq.com

Locations
China, Chongqing
Xinqiao Hospital, Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400037
Contact: Guangyou Duan, MD         
Sponsors and Collaborators
Xinqiao Hospital of Chongqing
Investigators
Principal Investigator: Hong Li, M.D. Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University

Responsible Party: Hong Li, Director, Department of Anesthesiology, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier: NCT03309163     History of Changes
Other Study ID Numbers: ETPPD Trail
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depression, Postpartum
Puerperal Disorders
Depressive Disorder
Behavioral Symptoms
Pregnancy Complications
Mood Disorders
Mental Disorders
Ropivacaine
Tramadol
Hydromorphone
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics