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Low-dose Ketamine and Postpartum Depression in Parturients With Prenatal Depression

P

Peking University

Status and phase

Completed
Phase 4

Conditions

Perinatal Depression
Ketamine
Cesarean Delivery
Postpartum Depression

Treatments

Drug: Placebo
Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT03336541
2017[36]

Details and patient eligibility

About

Postpartum depression is common in mothers early after childbirth and produces harmful effects not only on mothers, but also on infants and young children. Parturients with prenatal depression are at increased of postpartum depression. Low-dose ketamine can be used for antidepressant therapy. We hypothesize that low-dose ketamine has a therapeutic effect on parturients with prenatal depression. This study is designed to investigate whether low-dose ketamine administered during cesarean delivery can decrease the incidence of postpartum depression in parturients with prenatal depression.

Full description

Postpartum depression refers to maternal depression developed early after childbirth, with reported incidences varied from 15% to 20%. The development of postpartum depression produces harmful effects not only on mothers, but also on infants and young children. Prenatal depression or high depression score is an independent risk factor for the development of postpartum depression.

Ketamine is commonly used as an general anesthetic. In addition, low-dose ketamine is recommended for antidepressant therapy. We hypothesize that low-dose ketamine has a therapeutic effect on parturients with prenatal depression. However, evidences in this aspect are insufficient. The purpose of this study is to investigate whether low-dose ketamine administered during cesarean delivery can decrease the incidence of postpartum depression in parturients with prenatal depression.

Enrollment

64 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Parturients with age from 18 to 45 years and scheduled for elective cesarean delivery;
  • Prenatal depression score (EPDS) of 10 or higher;
  • Provide written informed consents.

Exclusion criteria

  • Refused to participate in the study;
  • History of schizophrenia or other disease that prevent normal communication before delivery;
  • Presence of contraindications to neuraxial anesthesia, including central nervous system diseases (such as poliomyelitis), spinal diseases (such as spinal canal tumor, lumbar disc prolapse, history of spinal trauma), systemic infection (such as sepsis, bacteremia), local infection in the site of puncture, or coagulopathy;
  • Severe complications during pregnancy (such as severe preeclampsia, placenta accreta, HELLP syndrome);
  • Severe comorbidity before pregnancy (such as severe cardiac dysfunction);
  • Scheduled to undergo cesarean delivery under general anesthesia;
  • Other reasons that are considered unsuitable for study participation.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

64 participants in 2 patient groups, including a placebo group

Ketamine group
Experimental group
Description:
Low-dose ketamine (0.5 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery.
Treatment:
Drug: Ketamine
Placebo group
Placebo Comparator group
Description:
Placebo (100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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