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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02823418

Enrollment

599

Registered

2016-07-06

Start date

2014-08-01

Completion date

2017-04-25

Last updated

2021-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Obstetrical, Depression, Postpartum, Parturition

Keywords

primipara, childbirth, neuraxial labor analgesia, postpartum depression

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.

Interventions

PROCEDURENo neuraxial labor analgesia

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

PROCEDURENeuraxial 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 34 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The incidence of postpartum depression	At 42 days after delivery	Postpartum depression will be defined by a score of 10 or more on the Edinburgh Postnatal Depression Scale.

Secondary

Measure	Time frame	Description
Neonatal Apgar score	At 1 and 5 minutes after delivery	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.
Status of baby feeding	At 24 hours and 42 days after delivery	The mode of baby feeding include breast feeding, mixed feeding, and formula feeding.
The mode of delivery	At the time of delivery	The mode of delivery includes spontaneous delivery, instrumental delivery, and Caesarean delivery.
Persistent pain	At 42 days after delivery	Persistence pain is defined as a NRS pain score ≥1 that persisted since childbirth.
Persistent pain affecting daily life	At 42 days after delivery	One of the following activities (including walking, mood, sleep or concentration) is affected by persistent pain, as judged by parturients themselves.
Severity of pain	At 24 hours and 42 days after delivery	Severity of pain is evaluated with Numeric Rating Scale (NRS), where 0 indicates no pain and 10 the most severe pain.

Other

Measure	Time frame	Description
Chronic pain affecting daily life	Up to 24 months after childbirth.	Defined as chronic pain that interfered daily life activities including walking, mood, sleep or concentration, as judged by parturients themselves.
Maternal disease after childbirth	Up to 24 months after childbirth	Refer to any new-onset disease that occurs after childbirth and requires medical therapy or surgical procedures.
Another childbirth	Up to 24 months after the first childbirth.	Another childbirth
Mental Development Index	Assessed between 23 to 24 months of age.	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.
2-year depression	Assessed between 23 to 24 months after childbirth.	2-year depression is assessed with the Edinburgh Postnatal Depression Scale, a score of 10 or higher is defined as the presence of depression.
Child body weight	Assessed between 23 to 24 months of age.	Child body weight
Child height	Assessed between 23 to 24 months of age.	Child height
Pediatric disease	Up to 24 months of age.	Indicates any congenital or acquired disease that requires medical therapy or surgical procedures.
Psychomotor Development Index	Assessed between 23 to 24 months of age.	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.
Degree of social support	Assessed between 23 to 24 months after childbirth.	Degree of social support is assessed with the Social Support Rating Scale, score range 11 to 62, with higher score indicating better social support.
Maternal body weight	Assessed between 23 to 24 months after childbirth.	Maternal body weight
Maternal height	Assessed between 23 to 24 months after childbirth.	Maternal height
Duration of breast-feeding	Up to 24 months after childbirth.	Duration of breast-feeding
Start of complementary feeding	Up to 24 months after childbirth.	Start of complementary feeding
Chronic pain after childbirth	Up to 24 months after childbirth.	Defined as persistent or recurrent pain that lasted for more than 3 months after childbirth.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026