Neuraxial Labor Analgesia and the Incidence of Postpartum Depression

NCT02823418 | Completed

• 2 other identifiers: 2014[712]ChiCTR-OCH-14004888
• Study Type: observational
• Target: 599
• Locations: 0 countries
• Sites: N/A

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

Conditions

Parturition; Analgesia, Obstetrical; Depression, Postpartum

Keywords

primipara; childbirth; neuraxial labor analgesia; postpartum depression

Outcome Measures

Primary Outcomes (1)

• The incidence of postpartum depression

  Postpartum depression will be defined by a score of 10 or more on the Edinburgh Postnatal Depression Scale.

  At 42 days after delivery

Secondary Outcomes (6)

• The mode of delivery

  At the time of delivery

• Neonatal Apgar score

  At 1 and 5 minutes after delivery

• Status of baby feeding

  At 24 hours and 42 days after delivery

• Severity of pain

  At 24 hours and 42 days after delivery

• Persistent pain

  At 42 days after delivery

Other Outcomes (15)

• 2-year depression

  Assessed between 23 to 24 months after childbirth.

• Degree of social support

  Assessed between 23 to 24 months after childbirth.

• Maternal body weight

  Assessed between 23 to 24 months after childbirth.

Study Arms (2)

No neuraxial labor analgesia

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

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.

Procedure: Neuraxial labor analgesia

Interventions

No neuraxial labor analgesia PROCEDURE

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

No neuraxial labor analgesia

Neuraxial labor analgesia 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.

Neuraxial labor analgesia

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Beijing Obstetrics and Gynecology Hospital: collaborator
• Beijing Haidian Maternal and Child Health Hospital: collaborator

Related Publications (7)

• 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.

  PMID: 24797120 BACKGROUND

• 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.

  PMID: 14995921 BACKGROUND

• 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.

  PMID: 18818022 BACKGROUND

• 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.

  PMID: 20121831 BACKGROUND

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

  PMID: 21072284 BACKGROUND

• 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.

  PMID: 35968440 DERIVED

• 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.

  PMID: 31356375 DERIVED

MeSH Terms

Conditions

Agnosia; Depression, Postpartum

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Dong-Xin Wang, MD,PHD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 6, 2016
• Study Start: August 1, 2014
• Primary Completion: May 29, 2015
• Study Completion: April 25, 2017
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share