A clinical trial to study the effect of analgesia during labour on post partum depression

Not yet recruiting

• Conditions: ASA Grade 1 and 2 parturients more than 18 years of age who give consent for labour analgesia

• Registration Number: CTRI/2016/04/006888
• Lead Sponsor: Government Medical College and Hospital

Brief Summary

This study is a randomised, prospective,open labled trial to evaluate the effect of combined spinal epidural analgesia during labour on post partum depression.The index group receiving the neuraxial block would be compared with the control normal vaginal delivery group for post partum depression, using the Edinburgh postnatal depression scale(EPDS) at 3 days and 6 weeks. The primary outcome measure would be prevalence(frequency in percentage) of post partum depression using EPDS questionnaire. The secondary outcome and observational measures would include Maternal satisfaction( based on score of Visual Analog scale), Pain score(VAS Score), Sensory and motor block characteristics, Haemodynamic parameters of mother, Foetal heart rate, Duration of second stage of labour, Mode of delivery, Apgar scores and adverse effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-09
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

ASA Grade 1 and 2 Age more than 18 years Primigravida Single gestation Cephalic presentation at 37 completed weeks of gestation In early spontaneous labour(cervical dilation < 5cm) Baseline pain score>30(on a VAS of 0-100) Able to use PCEA pump Parturients consenting to participate in the study.

Exclusion Criteria

• Refusal by parturient Patient failing to understand the functioning of PCEA pump and VAS scoring History of psychiatric disorder(GHQ12>2) Obesity(Wt>100kg) Parturients who have received oral or parenteral analgesics in the last 4 hours Systemic and local sepsis Deranged coagulation profile Preterm labour(<37 commpleted weeks) Obstetric complications(eg., PROM) Foetus with a non re-assuring NST Foetus with known or suspected congenital anomalies Allergy to study drugs i.e., levobupivacaine, fentanyl Patient with Diabetes(pre-existing or gestational) or history of immunosuppression.
• Patients with hypertension on methyldopa.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence(frequency in percentage) of post partum depression using EPDS questionnaire	Day 3 and 6 weeks

Secondary Outcome Measures

Name	Time	Method
Maternal satisfaction(VAS score)	Pain score(VAS score)

Trial Locations

Locations (1)

Labour room Operation theatre and Labour room; 🇮🇳 Chandigarh, CHANDIGARH, India

Labour room Operation theatre and Labour room

🇮🇳Chandigarh, CHANDIGARH, India

Dr Amrit Kaur

Principal investigator

9501415120

kauramrita.25@gmail.com