ParturitionNCT02823418

Neuraxial Labor Analgesia and the Incidence of Postpartum Depression

An observational study of Parturition and Analgesia, Obstetrical, run by Peking University First Hospital.

Completed

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

Trial summary

Postpartum depression (PPD) affects approximately 15% of women during the first year after giving birth, and is common across cultures. The etiology of postpartum depression is not totally clear. The severe pain experienced during childbirth was reported to be associated with the development of postpartum depression. Read more about this study

Who is it for?: Ages 18 to 34 years, women only
Conditions the study is for: Parturition, Analgesia, Obstetrical, Depression, Postpartum
What is being tested?: No neuraxial labor analgesia and Neuraxial labor analgesia
Type of treatment: Surgery or procedure
How many people: 599 participants
Where: No sites listed yet
Study dates: 1 Aug 2014to 25 Apr 2017
How long will I take part?: 2 Years
Phase: Observational
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 18 to 34 years
Women only
No healthy volunteers
Adult

Study population: Primiparae between 18 and 34 years of age with term single cephalic pregnancy who are preparing to deliver vaginally during the daytime hours.

Who may be able to join

Primiparae between 18 and 34 years of age with term single cephalic pregnancy;
Admitted to the delivery room during daytime working hours (from 8 am to 5 pm).
Preparing to deliver vaginally.

Who cannot join

History of psychiatric disease (indicate those that are diagnosed before or during pregnancy by psychiatrists);
Presence of contraindications to epidural analgesia, which includes: (1) History of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) History of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) Systemic infection (sepsis); (4) Skin or soft tissue infection at the site of epidural puncture; (5) Coagulopathy.
Other reasons that are considered unsuitable for study participation.

About this study

Official title: Impact of Neuraxial Labor Analgesia on the Incidence of Postpartum Depression: a Prospective, Observational, Multicenter Cohort Study

Read the detailed description

Postpartum depression (PPD) affects approximately 15% of women during the first year after giving birth, and is common across cultures. In postpartum Chinese women, the reported incidence ranged from 6.5% to 29.5%.

The etiology of postpartum depression is not totally clear. Identified risk factors include previous maternal blues, unplanned pregnancy, lack of marital or social support, and previous psychiatric illnesses. Furthermore, the severe pain experienced during childbirth was reported to be associated with the occurrence of postpartum depression.

A recent study of the investigators found that use of epidural analgesia during labor was associated with decreased risk of postpartum depression. However, several limitations existed in that study and further evidence is needed to reconfirm the finding. The purpose of the present study is to reevaluate whether use of neuraxial labor analgesia can reduce the incidence of postpartum depression.

Conditions: Parturition, Analgesia, Obstetrical, Depression, Postpartum
Being tested: No neuraxial labor analgesia, Neuraxial labor analgesia
Keywords: primipara, childbirth, neuraxial labor analgesia, postpartum depression
Medical subject headings: Agnosia, Depression, Postpartum

What participants receive

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

No neuraxial labor analgesiaProcedure or surgery
Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.
Neuraxial labor analgesiaProcedure or surgery
Epidural or combined spinal-epidural labor analgesia will be performed when the cervix is dilated to 1 cm or more and continued until the cervix is fully dilated to 10 cm.

Study groups in NCT02823418
Study group	Role	What they receive
No neuraxial labor analgesia		For patients who do not accept neuraxial labor analgesia, analgesics will be prescribed by obstetricians according to routine practice. Receives: Procedure: No neuraxial labor analgesia
Neuraxial labor analgesia		For patients who accept neuraxial labor analgesia, epidural analgesia or combined spinal-epidural analgesia will be provided when the cervix is dilated to 1 cm or more and continued until the cervix is fully dilated to 10 cm. Receives: Procedure: Neuraxial labor analgesia

What is being measured

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

The incidence of postpartum depression
Postpartum depression will be defined by a score of 10 or more on the Edinburgh Postnatal Depression Scale.
Measured: At 42 days after delivery

Secondary outcomes (6)

The mode of delivery
The mode of delivery includes spontaneous delivery, instrumental delivery, and Caesarean delivery.
Measured: At the time of delivery
Neonatal Apgar score
The Apgar score ranges from 0 to 10, with higher score indicating a better outcome. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.
Measured: At 1 and 5 minutes after delivery
Status of baby feeding
The mode of baby feeding include breast feeding, mixed feeding, and formula feeding.
Measured: At 24 hours and 42 days after delivery
Severity of pain
Severity of pain is evaluated with Numeric Rating Scale (NRS), where 0 indicates no pain and 10 the most severe pain.
Measured: At 24 hours and 42 days after delivery
Persistent pain
Persistence pain is defined as a NRS pain score ≥1 that persisted since childbirth.
Measured: At 42 days after delivery
Persistent pain affecting daily life
One of the following activities (including walking, mood, sleep or concentration) is affected by persistent pain, as judged by parturients themselves.
Measured: At 42 days after delivery

Timeline

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

1 Aug 201425 Apr 2017

First posted6 Jul 2016 (estimated)
Study start1 Aug 2014
Primary completion29 May 2015
Study completion25 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for ParturitionStudies of the same condition, open and under way.
More trials run by Peking University First HospitalThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 599 participants (actual)
Target duration: 2 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02823418
Sponsor's protocol ID: 2014[712]
Other IDs: ChiCTR-OCH-14004888
Status last verified: Jul 2021
First submitted: 28 Jun 2016
Last updated: 26 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ding T, Wang DX, Qu Y, Chen Q, Zhu SN. Epidural labor analgesia is associated with a decreased risk of postpartum depression: a prospective cohort study. Anesth Analg. 2014 Aug;119(2):383-392. doi: 10.1213/ANE.0000000000000107.
PubMed 24797120
Hiltunen P, Raudaskoski T, Ebeling H, Moilanen I. Does pain relief during delivery decrease the risk of postnatal depression? Acta Obstet Gynecol Scand. 2004 Mar;83(3):257-61. doi: 10.1111/j.0001-6349.2004.0302.x.
PubMed 14995921
Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
PubMed 18818022
Vigod SN, Villegas L, Dennis CL, Ross LE. Prevalence and risk factors for postpartum depression among women with preterm and low-birth-weight infants: a systematic review. BJOG. 2010 Apr;117(5):540-50. doi: 10.1111/j.1471-0528.2009.02493.x. Epub 2010 Jan 29.
PubMed 20121831
Wong CA. Advances in labor analgesia. Int J Womens Health. 2010 Aug 9;1:139-54. doi: 10.2147/ijwh.s4553.
PubMed 21072284
Deng CM, Ding T, Liu ZH, He ST, Ma JH, Xu MJ, Wang L, Li M, Liang WL, Li XY, Ma D, Wang DX. Impact of maternal neuraxial labor analgesia exposure on offspring's neurodevelopment: A longitudinal prospective cohort study with propensity score matching. Front Public Health. 2022 Jul 29;10:831538. doi: 10.3389/fpubh.2022.831538. eCollection 2022.
PubMed 35968440
Liu ZH, He ST, Deng CM, Ding T, Xu MJ, Wang L, Li XY, Wang DX. Neuraxial labour analgesia is associated with a reduced risk of maternal depression at 2 years after childbirth: A multicentre, prospective, longitudinal study. Eur J Anaesthesiol. 2019 Oct;36(10):745-754. doi: 10.1097/EJA.0000000000001058.
PubMed 31356375

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?

Official record

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Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
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nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
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RecruitingPhase 1
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Overweight and/or Obesity, Healthy Participants
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Parturition trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Neuraxial Labor Analgesia on the Incidence of Postpartum Depression: a Prospective, Observational, Multicenter Cohort Study
ClinicalTrials.gov ID: NCT02823418
Acronym / sponsor ID: 2014[712]
Conditions: Parturition, Analgesia, Obstetrical, Depression, Postpartum
Keywords: primipara, childbirth, neuraxial labor analgesia, postpartum depression
Study type: Observational
Recruitment status: Completed
Enrolment: 599 participants (actual)
Lead sponsor: Peking University First HospitalUniversity, hospital or other
Collaborators: Beijing Obstetrics and Gynecology Hospital, Beijing Haidian Maternal and Child Health Hospital
Study start: 1 Aug 2014 (actual)
Primary completion: 29 May 2015 (actual)
Study completion: 25 Apr 2017 (actual)
First posted: 6 Jul 2016 (estimated)
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

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 2 Years
Number of arms: 2

Arm	Type	Receives
No neuraxial labor analgesia	–	Procedure: No neuraxial labor analgesiaFor patients who do not accept neuraxial labor analgesia, analgesics will be prescribed by obstetricians according to routine practice.
Neuraxial labor analgesia	–	Procedure: Neuraxial labor analgesiaFor patients who accept neuraxial labor analgesia, epidural analgesia or combined spinal-epidural analgesia will be provided when the cervix is dilated to 1 cm or more and continued until the cervix is fully dilated to 10 cm.

Who may qualify

Ages: 18 to 34 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Primiparae between 18 and 34 years of age with term single cephalic pregnancy who are preparing to deliver vaginally during the daytime hours.

Key inclusion criteria (3 listed)

Primiparae between 18 and 34 years of age with term single cephalic pregnancy;
Admitted to the delivery room during daytime working hours (from 8 am to 5 pm).
Preparing to deliver vaginally.

Key exclusion criteria (3 listed)

History of psychiatric disease (indicate those that are diagnosed before or during pregnancy by psychiatrists);
Presence of contraindications to epidural analgesia, which includes: (1) History of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) History of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) Systemic infection (sepsis); (4) Skin or soft tissue infection at the site of epidural puncture; (5) Coagulopathy.
Other reasons that are considered unsuitable for study participation.

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
No neuraxial labor analgesiaNeuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.	Procedure or surgery	No neuraxial labor analgesia
Neuraxial labor analgesiaEpidural or combined spinal-epidural labor analgesia will be performed when the cervix is dilated to 1 cm or more and continued until the cervix is fully dilated to 10 cm.	Procedure or surgery	Neuraxial labor analgesia

Primary outcome

The incidence of postpartum depression
Time frame: At 42 days after delivery
Postpartum depression will be defined by a score of 10 or more on the Edinburgh Postnatal Depression Scale.

6 secondary outcomes

The mode of delivery
Time frame: At the time of delivery
Neonatal Apgar score
Time frame: At 1 and 5 minutes after delivery
Status of baby feeding
Time frame: At 24 hours and 42 days after delivery
Severity of pain
Time frame: At 24 hours and 42 days after delivery
Persistent pain
Time frame: At 42 days after delivery
Persistent pain affecting daily life
Time frame: At 42 days after delivery

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 26 Jul 2021.
Background: PubMed 24797120Ding T, Wang DX, Qu Y, Chen Q, Zhu SN. Epidural labor analgesia is associated with a decreased risk of postpartum depression: a prospective cohort study. Anesth Analg. 2014 Aug;119(2):383-392. doi: 10.1213/ANE.0000000000000107.
Background: PubMed 14995921Hiltunen P, Raudaskoski T, Ebeling H, Moilanen I. Does pain relief during delivery decrease the risk of postnatal depression? Acta Obstet Gynecol Scand. 2004 Mar;83(3):257-61. doi: 10.1111/j.0001-6349.2004.0302.x.
Background: PubMed 18818022Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
Background: PubMed 20121831Vigod SN, Villegas L, Dennis CL, Ross LE. Prevalence and risk factors for postpartum depression among women with preterm and low-birth-weight infants: a systematic review. BJOG. 2010 Apr;117(5):540-50. doi: 10.1111/j.1471-0528.2009.02493.x. Epub 2010 Jan 29.
Background: PubMed 21072284Wong CA. Advances in labor analgesia. Int J Womens Health. 2010 Aug 9;1:139-54. doi: 10.2147/ijwh.s4553.
Derived from this study: PubMed 35968440Deng CM, Ding T, Liu ZH, He ST, Ma JH, Xu MJ, Wang L, Li M, Liang WL, Li XY, Ma D, Wang DX. Impact of maternal neuraxial labor analgesia exposure on offspring's neurodevelopment: A longitudinal prospective cohort study with propensity score matching. Front Public Health. 2022 Jul 29;10:831538. doi: 10.3389/fpubh.2022.831538. eCollection 2022.
Derived from this study: PubMed 31356375Liu ZH, He ST, Deng CM, Ding T, Xu MJ, Wang L, Li XY, Wang DX. Neuraxial labour analgesia is associated with a reduced risk of maternal depression at 2 years after childbirth: A multicentre, prospective, longitudinal study. Eur J Anaesthesiol. 2019 Oct;36(10):745-754. doi: 10.1097/EJA.0000000000001058.
Individual participant dataSharing planned: No

Related trials for Parturition

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

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.

Dong-Xin Wang, MD,PHD principal investigator

Peking University First Hospital

Questions about this trial

What is this clinical trial studying?

An observational study of Parturition and Analgesia, Obstetrical, run by Peking University First Hospital.

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 3 inclusion and 3 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 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

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 42 days after delivery). 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 NCT02823418, which also lists 7 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 26 Jul 2021.