Neuraxial Labor Analgesia and the Incidence of Postpartum Depression

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

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.

Study Overview

• Status: Completed
• Conditions: Depression, Postpartum; Parturition; Analgesia, Obstetrical
• Intervention / Treatment: Procedure: No neuraxial labor analgesia; Procedure: Neuraxial labor analgesia

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.

• Study Type: Observational
• Enrollment (Actual): 599

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mode of delivery	The mode of delivery includes spontaneous delivery, instrumental delivery, and Caesarean delivery.	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.	At 1 and 5 minutes after delivery
Status of baby feeding	The mode of baby feeding include breast feeding, mixed feeding, and formula feeding.	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.	At 24 hours and 42 days after delivery
Persistent pain	Persistence pain is defined as a NRS pain score ≥1 that persisted since childbirth.	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.	At 42 days after delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year depression	2-year depression is assessed with the Edinburgh Postnatal Depression Scale, a score of 10 or higher is defined as the presence of depression.	Assessed between 23 to 24 months after childbirth.
Degree of social support	Degree of social support is assessed with the Social Support Rating Scale, score range 11 to 62, with higher score indicating better social support.	Assessed between 23 to 24 months after childbirth.
Maternal body weight	Maternal body weight	Assessed between 23 to 24 months after childbirth.
Maternal height	Maternal height	Assessed between 23 to 24 months after childbirth.
Duration of breast-feeding	Duration of breast-feeding	Up to 24 months after childbirth.
Start of complementary feeding	Start of complementary feeding	Up to 24 months after childbirth.
Chronic pain after childbirth	Defined as persistent or recurrent pain that lasted for more than 3 months after childbirth.	Up to 24 months after childbirth.
Chronic pain affecting daily life	Defined as chronic pain that interfered daily life activities including walking, mood, sleep or concentration, as judged by parturients themselves.	Up to 24 months after childbirth.
Maternal disease after childbirth	Refer to any new-onset disease that occurs after childbirth and requires medical therapy or surgical procedures.	Up to 24 months after childbirth
Another childbirth	Another childbirth	Up to 24 months after the first childbirth.
Mental Development Index	Assessed with the Mental Scale subtest of the Bayley Scales of Infant Development-Chinese Revision. The subtest includes 163 items and assesses adaptive behavior, language and cognitive ability. The raw score of successfully completed items is converted to the standardized Mental Development Index. The average score of Mental Development Index in normal urban children is 100 with a SD of 15, with higher score indicating better development.	Assessed between 23 to 24 months of age.
Psychomotor Development Index	Assessed with the Motor Scale subtest of the Bayley Scales of Infant Development-Chinese Revision. The subtest includes 81 items and assesses gross and fine motor skills. The raw score of successfully completed items is converted to the standardized Psychomotor Development Index. The average score of Psychomotor Development Index in normal urban children is 100 with a SD of 15, with higher score indicating better development.	Assessed between 23 to 24 months of age.
Child body weight	Child body weight	Assessed between 23 to 24 months of age.
Child height	Child height	Assessed between 23 to 24 months of age.
Pediatric disease	Indicates any congenital or acquired disease that requires medical therapy or surgical procedures.	Up to 24 months of age.

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Beijing Haidian Maternal and Child Health Hospital; Beijing Obstetrics and Gynecology Hospital

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2014
• Primary Completion (ACTUAL): May 29, 2015
• Study Completion (ACTUAL): April 25, 2017

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (ESTIMATE): July 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: postpartum depression; childbirth; primipara; neuraxial labor analgesia
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 2014[712]; ChiCTR-OCH-14004888 (REGISTRY: Chinese Clinical Trial Registry (www.chictr.org.cn))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No