Neuraxial Labor Analgesia and the Incidence of Postpartum Depression

Depression, Postpartum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823418
• Other study ID #: 2014[712]
• Secondary ID: ChiCTR-OCH-14004
• Status: Completed
• Start date: August 1, 2014
• Est. completion date: April 25, 2017

Study information

• Verified date: July 2021
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 599
• Est. completion date: April 25, 2017
• Est. primary completion date: May 29, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia, Obstetrical
• Depression
• Depression, Postpartum
• Depressive Disorder
• Parturition

Intervention

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
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Peking University First Hospital	Beijing Haidian Maternal and Child Health Hospital, Beijing Obstetrics and Gynecology Hospital

References & Publications (5)

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):383-92. doi: 10.1213/ANE.0000000000000107. — View 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. — View 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. — View 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. Review. — View Citation

Wong CA. Advances in labor analgesia. Int J Womens Health. 2010 Aug 9;1:139-54. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	Maternal body weight	Maternal body weight	Assessed between 23 to 24 months after childbirth.
Other	Maternal height	Maternal height	Assessed between 23 to 24 months after childbirth.
Other	Duration of breast-feeding	Duration of breast-feeding	Up to 24 months after childbirth.
Other	Start of complementary feeding	Start of complementary feeding	Up to 24 months after childbirth.
Other	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.
Other	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.
Other	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
Other	Another childbirth	Another childbirth	Up to 24 months after the first childbirth.
Other	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.
Other	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.
Other	Child body weight	Child body weight	Assessed between 23 to 24 months of age.
Other	Child height	Child height	Assessed between 23 to 24 months of age.
Other	Pediatric disease	Indicates any congenital or acquired disease that requires medical therapy or surgical procedures.	Up to 24 months of age.
Primary	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	The mode of delivery	The mode of delivery includes spontaneous delivery, instrumental delivery, and Caesarean delivery.	At the time of delivery
Secondary	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
Secondary	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
Secondary	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
Secondary	Persistent pain	Persistence pain is defined as a NRS pain score =1 that persisted since childbirth.	At 42 days after delivery
Secondary	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