Neuraxial Labor Analgesia and the Incidence of Postpartum Depression

Completed

• Conditions: Parturition; Depression, Postpartum; Analgesia, Obstetrical

• Registration Number: NCT02823418
• Lead Sponsor: Peking University First Hospital

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.

Study Timeline

• Study Start: 2014-08-01
• Primary Completion: 2015-05-29
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-06
• Study Completion: 2017-04-25
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 599

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Persistent pain	At 42 days after delivery	Persistence pain is defined as a NRS pain score ≥1 that persisted since childbirth.
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.
The mode of delivery	At the time of delivery	The mode of delivery includes spontaneous delivery, instrumental delivery, and Caesarean delivery.
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.
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.