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Effect of Tramadol in Prevention of Postpartum Depression (ETPPD)

Primary Purpose

Caesarean Section

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tramadol
Hydromorphone
Ropivacaine (Epidural analgesia)
Sponsored by
Xinqiao Hospital of Chongqing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caesarean Section

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Xinqiao Hospital, Third Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Group T

Group H

Group E

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

The incidence of postpartum depression
Diagnosed according to DSM-5 diagnostic criteria for postnatal depression

Secondary Outcome Measures

The incidence of postpartum depression
Diagnosed according to DSM-5 diagnostic criteria for postnatal depression
EPDS scores
Measured using Edinburgh Postnatal Depression Scale
GAD-7 scores
Measured using Generalized Anxiety Disorder Scale
QoR-15 scores
Measured using Quality of recovery 15
Pain intensity
Pain VAS at 6, 12, 24 and 48 hours after the surgery
Norepinephrine and serotonin levels in the blood
Norepinephrine and serotonin concentration in the blood at 48 hours after the surgery

Full Information

First Posted
September 28, 2017
Last Updated
August 13, 2019
Sponsor
Xinqiao Hospital of Chongqing
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1. Study Identification

Unique Protocol Identification Number
NCT03309163
Brief Title
Effect of Tramadol in Prevention of Postpartum Depression
Acronym
ETPPD
Official Title
Effect of Tramadol in Prevention of Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
June 13, 2019 (Actual)
Study Completion Date
August 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinqiao Hospital of Chongqing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caesarean Section

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group T
Arm Type
Active Comparator
Arm Description
All patients receive the patient-controlled intravenous analgesia with Tramadol.
Arm Title
Group H
Arm Type
Placebo Comparator
Arm Description
All patients receive the patient-controlled intravenous analgesia with Hydromorphone.
Arm Title
Group E
Arm Type
Placebo Comparator
Arm Description
All patients receive the patient-controlled epidural analgesia with Ropivacaine.
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
Patient-controlled intravenous analgesia with Tramadol
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Intervention Description
Patient-controlled intravenous analgesia with Hydromorphone
Intervention Type
Drug
Intervention Name(s)
Ropivacaine (Epidural analgesia)
Intervention Description
Patient-controlled epidural analgesia with Ropivacaine.
Primary Outcome Measure Information:
Title
The incidence of postpartum depression
Description
Diagnosed according to DSM-5 diagnostic criteria for postnatal depression
Time Frame
At 4 weeks after the surgery
Secondary Outcome Measure Information:
Title
The incidence of postpartum depression
Description
Diagnosed according to DSM-5 diagnostic criteria for postnatal depression
Time Frame
At 3 months after the surgery
Title
EPDS scores
Description
Measured using Edinburgh Postnatal Depression Scale
Time Frame
At 4 weeks and 3 months after the surgery
Title
GAD-7 scores
Description
Measured using Generalized Anxiety Disorder Scale
Time Frame
At 4 weeks and 3 months after the surgery
Title
QoR-15 scores
Description
Measured using Quality of recovery 15
Time Frame
48 hours after the surgery
Title
Pain intensity
Description
Pain VAS at 6, 12, 24 and 48 hours after the surgery
Time Frame
At 6, 12, 24 and 48 hours after the surgery
Title
Norepinephrine and serotonin levels in the blood
Description
Norepinephrine and serotonin concentration in the blood at 48 hours after the surgery
Time Frame
At 48 hours after the surgery
Other Pre-specified Outcome Measures:
Title
Early walking time
Description
The time for patient to independently activity
Time Frame
During hospitalization, an average of 36 hours
Title
Hospital stays
Description
The time for patient to stay in hospital after the surgery
Time Frame
During hospitalization, an average of 72 hours
Title
Pain intensity
Description
Postoperative pain intensity that evaluated by questionnaire at 3 months after the surgery
Time Frame
At 3 months after the surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Li, M.D.
Organizational Affiliation
Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinqiao Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34124111
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.
Results Reference
derived
PubMed Identifier
30344172
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.
Results Reference
derived

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Effect of Tramadol in Prevention of Postpartum Depression

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