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NCT Number: NCT03309163

Effect of Tramadol in Prevention of Postpartum Depression

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.

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Key information

Conditions

Caesarean Section

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Xinqiao Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tramadol

Drug

Patient-controlled intravenous analgesia with Tramadol

Hydromorphone

Drug

Patient-controlled intravenous analgesia with Hydromorphone

Ropivacaine (Epidural analgesia)

Drug

Patient-controlled epidural analgesia with Ropivacaine.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Registry information

Acronym: ETPPD

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 13, 2017
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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