Clinical trial NCT02823418: Neuraxial Labor Analgesia and the Incidence of Postpartum Depression
Official title: Impact of Neuraxial Labor Analgesia on the Incidence of Postpartum Depression: a Prospective, Observational, Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parturition
Analgesia, Obstetrical
Depression, Postpartum
Keywords: primipara
childbirth
neuraxial labor analgesia
postpartum depression
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Obstetrics and Gynecology Hospital
name: Beijing Haidian Maternal and Child Health Hospital
First posted: 2016-07-06
Enrollment: 599
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of postpartum depression
timeFrame: At 42 days after delivery
Secondary outcomes:
measure: The mode of delivery
timeFrame: At the time of delivery
measure: Neonatal Apgar score
timeFrame: At 1 and 5 minutes after delivery
measure: Status of baby feeding
timeFrame: At 24 hours and 42 days after delivery
measure: Severity of pain
timeFrame: At 24 hours and 42 days after delivery
measure: Persistent pain
timeFrame: At 42 days after delivery
measure: Persistent pain affecting daily life
timeFrame: At 42 days after delivery
Other outcomes:
measure: 2-year depression
timeFrame: Assessed between 23 to 24 months after childbirth.
measure: Degree of social support
timeFrame: Assessed between 23 to 24 months after childbirth.
measure: Maternal body weight
timeFrame: Assessed between 23 to 24 months after childbirth.
measure: Maternal height
timeFrame: Assessed between 23 to 24 months after childbirth.
measure: Duration of breast-feeding
timeFrame: Up to 24 months after childbirth.
measure: Start of complementary feeding
timeFrame: Up to 24 months after childbirth.
measure: Chronic pain after childbirth
timeFrame: Up to 24 months after childbirth.
measure: Chronic pain affecting daily life
timeFrame: Up to 24 months after childbirth.
measure: Maternal disease after childbirth
timeFrame: Up to 24 months after childbirth
measure: Another childbirth
timeFrame: Up to 24 months after the first childbirth.
measure: Mental Development Index
timeFrame: Assessed between 23 to 24 months of age.
measure: Psychomotor Development Index
timeFrame: Assessed between 23 to 24 months of age.
measure: Child body weight
timeFrame: Assessed between 23 to 24 months of age.
measure: Child height
timeFrame: Assessed between 23 to 24 months of age.
measure: Pediatric disease
timeFrame: Up to 24 months of age.
Locations:
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Wong CA. Advances in labor analgesia. Int J Womens Health. 2010 Aug 9;1:139-54. doi: 10.2147/ijwh.s4553.
citation: 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.
citation: 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.