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

NCT03336541 | Completed Phase 4 DMC

• 1 other identifier: 2017[36]
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perinatal Depression; Ketamine; Cesarean Delivery; Postpartum Depression

Keywords

Prenatal depression; Ketamine; Cesarean delivery; Postpartum depression

Outcome Measures

Primary Outcomes (1)

• The score of postpartum depression at 48 hous after childbirth.

  Postpartum depression is assessed with Edinburgh postnatal depression scale (EPDS) at 48 hours after childbirth. The EPDS is a 10-item self-rating post-natal depression scale. Each item is scored from 0 to 3, resulting an overall score ranging from 0-30; a high score indicates severe depression.

  At 48 hours after delivery.

Secondary Outcomes (8)

• Time of first breast feeding.

  From delivery to 24 hours after delivery.

• The proportion of neonates with breast feeding.

  At 24 hours after delivery.

• Duration of neonatal sleep within 24 hours after delivery.

  During the first 24 hours after delivery.

• Length of stay in hospital after delivery.

  From childbirth up to 30 days after delivery.

• The score of postpartum depression at 42 days after delivery.

  At 42 days after delivery.

Study Arms (2)

Ketamine group

EXPERIMENTAL

Low-dose ketamine (0.5 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery.

Drug: Ketamine

Placebo group

PLACEBO COMPARATOR

Placebo (100 ml normal saline) is intravenously infused in 40 minutes after childbirth during cesarean delivery.

Drug: Placebo

Interventions

Ketamine DRUG

Ketamine (0.5 mg/kg in 100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.

Also known as: Ketamine hydrochloride

Ketamine group

Placebo DRUG

Placebo (100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.

Also known as: Normal saline

Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (25)

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• Wang S, Deng CM, Zeng Y, Ma JH, Qu Y, Wang DX. Single low-dose ketamine infusion for women with prenatal depressive symptoms undergoing cesarean delivery: A pilot randomized trial. Front Surg. 2022 Dec 8;9:1050232. doi: 10.3389/fsurg.2022.1050232. eCollection 2022.

  PMID: 36570810 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 8, 2017
• Study Start: November 23, 2017
• Primary Completion: May 14, 2018
• Study Completion: June 25, 2018
• Last Updated: December 13, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)