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| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR-OCH-14004888 | Registry Identifier | Chinese Clinical Trial Registry (www.chictr.org.cn) |
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| Name | Class |
|---|---|
| Beijing Obstetrics and Gynecology Hospital | OTHER |
| Beijing Haidian Maternal and Child Health Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No neuraxial labor analgesia | For patients who do not accept neuraxial labor analgesia, analgesics will be prescribed by obstetricians according to routine practice. |
| |
| Neuraxial labor analgesia | For patients who accept neuraxial labor analgesia, epidural analgesia or combined spinal-epidural analgesia will be provided when the cervix is dilated to 1 cm or more and continued until the cervix is fully dilated to 10 cm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No neuraxial labor analgesia | Procedure | Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The mode of delivery | The mode of delivery includes spontaneous delivery, instrumental delivery, and Caesarean delivery. | At the time of delivery |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Degree of social support |
Inclusion Criteria:
Exclusion Criteria:
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Primiparae between 18 and 34 years of age with term single cephalic pregnancy who are preparing to deliver vaginally during the daytime hours.
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| Name | Affiliation | Role |
|---|---|---|
| Dong-Xin Wang, MD,PHD | Peking University First Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24797120 | Background | 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. | |
| 14995921 | Background | 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. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 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. |
|
| At 1 and 5 minutes after delivery |
| 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 |
| 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 |
| Persistent pain | Persistence pain is defined as a NRS pain score ≥1 that persisted since childbirth. | At 42 days after delivery |
| 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 |
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. |
| Maternal body weight | Maternal body weight | Assessed between 23 to 24 months after childbirth. |
| Maternal height | Maternal height | Assessed between 23 to 24 months after childbirth. |
| Duration of breast-feeding | Duration of breast-feeding | Up to 24 months after childbirth. |
| Start of complementary feeding | Start of complementary feeding | Up to 24 months after childbirth. |
| 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. |
| 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. |
| 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 |
| Another childbirth | Another childbirth | Up to 24 months after the first childbirth. |
| 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. |
| 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. |
| Child body weight | Child body weight | Assessed between 23 to 24 months of age. |
| Child height | Child height | Assessed between 23 to 24 months of age. |
| Pediatric disease | Indicates any congenital or acquired disease that requires medical therapy or surgical procedures. | Up to 24 months of age. |
| 18818022 | Background | 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. |
| 20121831 | Background | 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. |
| 21072284 | Background | Wong CA. Advances in labor analgesia. Int J Womens Health. 2010 Aug 9;1:139-54. doi: 10.2147/ijwh.s4553. |
| 35968440 | Derived | 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. |
| 31356375 | Derived | 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |