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NCT Number: NCT02823418

Neuraxial Labor Analgesia and the Incidence of Postpartum Depression

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.

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Key information

Conditions

Parturition Agnosia Analgesia, Obstetrical Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Pregnancy Complications Puerperal Disorders Signs and Symptoms Urogenital Diseases

Age range

18 year–34 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

No neuraxial labor analgesia

Procedure

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

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.

Primary outcomes

  1. The incidence of postpartum depression

    Time frame: At 42 days after delivery

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

Secondary outcomes

  1. The mode of delivery

    Time frame: At the time of delivery

    The mode of delivery includes spontaneous delivery, instrumental delivery, and Caesarean delivery.

  2. Neonatal Apgar score

    Time frame: 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.

  3. Status of baby feeding

    Time frame: At 24 hours and 42 days after delivery

    The mode of baby feeding include breast feeding, mixed feeding, and formula feeding.

  4. Severity of pain

    Time frame: 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.

  5. Persistent pain

    Time frame: At 42 days after delivery

    Persistence pain is defined as a NRS pain score ≥1 that persisted since childbirth.

  6. Persistent pain affecting daily life

    Time frame: 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.

Other outcomes

  1. 2-year depression

    Time frame: 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.

  2. Degree of social support

    Time frame: 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.

  3. Maternal body weight

    Time frame: Assessed between 23 to 24 months after childbirth.

    Maternal body weight

  4. Maternal height

    Time frame: Assessed between 23 to 24 months after childbirth.

    Maternal height

  5. Duration of breast-feeding

    Time frame: Up to 24 months after childbirth.

    Duration of breast-feeding

  6. Start of complementary feeding

    Time frame: Up to 24 months after childbirth.

    Start of complementary feeding

  7. Chronic pain after childbirth

    Time frame: Up to 24 months after childbirth.

    Defined as persistent or recurrent pain that lasted for more than 3 months after childbirth.

  8. Chronic pain affecting daily life

    Time frame: 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.

  9. Maternal disease after childbirth

    Time frame: Up to 24 months after childbirth

    Refer to any new-onset disease that occurs after childbirth and requires medical therapy or surgical procedures.

  10. Another childbirth

    Time frame: Up to 24 months after the first childbirth.

    Another childbirth

  11. Mental Development Index

    Time frame: 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.

  12. Psychomotor Development Index

    Time frame: 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.

  13. Child body weight

    Time frame: Assessed between 23 to 24 months of age.

    Child body weight

  14. Child height

    Time frame: Assessed between 23 to 24 months of age.

    Child height

  15. Pediatric disease

    Time frame: Up to 24 months of age.

    Indicates any congenital or acquired disease that requires medical therapy or surgical procedures.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Beijing Haidian Maternal and Child Health Hospital
  • Beijing Obstetrics and Gynecology Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jul 6, 2016
Registry last updated
Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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