Caesarean SectionPhase 4ETPPDNCT03309163

Effect of Tramadol in Prevention of Postpartum Depression

A Phase 4 study testing Tramadol, Hydromorphone and Ropivacaine (Epidural analgesia) in people with Caesarean Section, run by Xinqiao Hospital of Chongqing at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 40 years, women only
Conditions the study is for: Caesarean Section
What is being tested?: Tramadol, Hydromorphone and Ropivacaine (Epidural analgesia)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,230 participants
Where: 1 siteChina
Study dates: 9 Oct 2017to 13 Aug 2019
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Xinqiao Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400037

Other trials in China

About this study

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.

Read the 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.

Conditions: Caesarean Section
Being tested: Tramadol, Hydromorphone, Ropivacaine (Epidural analgesia)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TramadolDrug
Patient-controlled intravenous analgesia with Tramadol
HydromorphoneDrug
Patient-controlled intravenous analgesia with Hydromorphone
Ropivacaine (Epidural analgesia)Drug
Patient-controlled epidural analgesia with Ropivacaine.

Study groups in NCT03309163
Study group	Role	What they receive
Group T	Active comparator	All patients receive the patient-controlled intravenous analgesia with Tramadol. Receives: Drug: Tramadol
Group H	Placebo comparator	All patients receive the patient-controlled intravenous analgesia with Hydromorphone. Receives: Drug: Hydromorphone
Group E	Placebo comparator	All patients receive the patient-controlled epidural analgesia with Ropivacaine. Receives: Drug: Ropivacaine (Epidural analgesia)

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence of postpartum depression
Diagnosed according to DSM-5 diagnostic criteria for postnatal depression
Measured: At 4 weeks after the surgery

Secondary outcomes (6)

The incidence of postpartum depression
Diagnosed according to DSM-5 diagnostic criteria for postnatal depression
Measured: At 3 months after the surgery
EPDS scores
Measured using Edinburgh Postnatal Depression Scale
Measured: At 4 weeks and 3 months after the surgery
GAD-7 scores
Measured using Generalized Anxiety Disorder Scale
Measured: At 4 weeks and 3 months after the surgery
QoR-15 scores
Measured using Quality of recovery 15
Measured: 48 hours after the surgery
Pain intensity
Pain VAS at 6, 12, 24 and 48 hours after the surgery
Measured: 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
Measured: At 48 hours after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Oct 201713 Aug 2019

First posted13 Oct 2017
Study start9 Oct 2017
Primary completion13 Jun 2019
Study completion13 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Caesarean SectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03309163
Sponsor's protocol ID: ETPPD Trail
Acronym: ETPPD
Status last verified: Aug 2019
First submitted: 28 Sep 2017
Last updated: 14 Aug 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 34124111
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.
PubMed 30344172

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Efficacy and Safety of Intrathecal Morphine for Postoperative Pain Management Following Planned Caesarean Section
Caesarean Section, Postoperative Pain
Not yet recruitingObservational study
SurgWeek-2: Identifying the Global Burden of Post Operative Complications: an International Prospective Cohort Study Protocol
Surgery Complications, Surgery
Active, not recruiting
A Multimedia Presentation to Augment the Informed Consent Process for Anesthesia for Patients Undergoing Scheduled Caesarian Delivery
Pregnancy, Caesarean Section
Enrolling by invitationObservational study
Maternal Hypothermia After Caesarean Section - Implications for Postoperative Recovery
Caesarean Section
Not yet recruitingPhase 4
Fixed-Mass Different Volumes Bupivacaine TAP Block After Cesarean
TAP Block, Caesarean Section

All Caesarean Section trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Tramadol in Prevention of Postpartum Depression
ClinicalTrials.gov ID: NCT03309163
Acronym / sponsor ID: ETPPD / ETPPD Trail
Conditions: Caesarean Section
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,230 participants (actual)
Lead sponsor: Xinqiao Hospital of ChongqingUniversity, hospital or other
Study start: 9 Oct 2017 (actual)
Primary completion: 13 Jun 2019 (actual)
Study completion: 13 Aug 2019 (actual)
First posted: 13 Oct 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group T	Active comparator	Drug: TramadolAll patients receive the patient-controlled intravenous analgesia with Tramadol.
Group H	Placebo comparator	Drug: HydromorphoneAll patients receive the patient-controlled intravenous analgesia with Hydromorphone.
Group E	Placebo comparator	Drug: Ropivacaine (Epidural analgesia)All patients receive the patient-controlled epidural analgesia with Ropivacaine.

Who may qualify

Ages: 20 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TramadolPatient-controlled intravenous analgesia with Tramadol	Drug	Group T
HydromorphonePatient-controlled intravenous analgesia with Hydromorphone	Drug	Group H
Ropivacaine (Epidural analgesia)Patient-controlled epidural analgesia with Ropivacaine.	Drug	Group E

Primary outcome

The incidence of postpartum depression
Time frame: At 4 weeks after the surgery
Diagnosed according to DSM-5 diagnostic criteria for postnatal depression

6 secondary outcomes

The incidence of postpartum depression
Time frame: At 3 months after the surgery
EPDS scores
Time frame: At 4 weeks and 3 months after the surgery
GAD-7 scores
Time frame: At 4 weeks and 3 months after the surgery
QoR-15 scores
Time frame: 48 hours after the surgery
Pain intensity
Time frame: At 6, 12, 24 and 48 hours after the surgery
Norepinephrine and serotonin levels in the blood
Time frame: At 48 hours after the surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
Derived from this study: PubMed 34124111Wu 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.
Derived from this study: PubMed 30344172Duan 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.
Individual participant dataSharing planned: Undecided

Related trials for Caesarean Section

RecruitingPhase 4
Efficacy and Safety of Intrathecal Morphine for Postoperative Pain Management Following Planned Caesarean Section
Caesarean Section, Postoperative Pain
Not yet recruitingObservational study
SurgWeek-2: Identifying the Global Burden of Post Operative Complications: an International Prospective Cohort Study Protocol
Surgery Complications, Surgery
Active, not recruiting
A Multimedia Presentation to Augment the Informed Consent Process for Anesthesia for Patients Undergoing Scheduled Caesarian Delivery
Pregnancy, Caesarean Section
Enrolling by invitationObservational study
Maternal Hypothermia After Caesarean Section - Implications for Postoperative Recovery
Caesarean Section
Not yet recruitingPhase 4
Fixed-Mass Different Volumes Bupivacaine TAP Block After Cesarean
TAP Block, Caesarean Section

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hong Li, M.D. principal investigator

Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tramadol, Hydromorphone and Ropivacaine (Epidural analgesia) in people with Caesarean Section, run by Xinqiao Hospital of Chongqing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of postpartum depression (time frame: At 4 weeks after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03309163, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.