Neuraxial Labor Analgesia and the Incidence of Postpartum Depression

NCT ID: NCT02823418

Last Updated: 2021-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

599 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-01

Study Completion Date

2017-04-25

Brief Summary

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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. The purpose of the present study is to evaluate whether use of neuraxial labor analgesia can reduce the incidence of postpartum depression.

Detailed Description

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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

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Parturition Analgesia, Obstetrical Depression, Postpartum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No neuraxial labor analgesia

For patients who do not accept neuraxial labor analgesia, analgesics will be prescribed by obstetricians according to routine practice.

No neuraxial labor analgesia

Intervention Type PROCEDURE

Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.

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.

Neuraxial labor analgesia

Intervention Type PROCEDURE

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.

Interventions

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No neuraxial labor analgesia

Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.

Intervention Type PROCEDURE

Neuraxial labor analgesia

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. History of psychiatric disease (indicate those that are diagnosed before or during pregnancy by psychiatrists);
2. 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.
3. Other reasons that are considered unsuitable for study participation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beijing Obstetrics and Gynecology Hospital

OTHER

Sponsor Role collaborator

Beijing Haidian Maternal and Child Health Hospital

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Xin Wang

Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong-Xin Wang, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

References

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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.

Reference Type BACKGROUND
PMID: 24797120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14995921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18818022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20121831 (View on PubMed)

Wong CA. Advances in labor analgesia. Int J Womens Health. 2010 Aug 9;1:139-54. doi: 10.2147/ijwh.s4553.

Reference Type BACKGROUND
PMID: 21072284 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35968440 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31356375 (View on PubMed)

Other Identifiers

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ChiCTR-OCH-14004888

Identifier Type: REGISTRY

Identifier Source: secondary_id

2014[712]

Identifier Type: -

Identifier Source: org_study_id

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