Condition category
Mental and Behavioural Disorders
Date applied
28/11/2018
Date assigned
17/12/2018
Last edited
18/12/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Depression after birth is a disorder of pregnant women, manifesting itself with a depressed
mood, insomnia or somnolence, marked weight loss, psychomotor retardation, a lowered
self-esteem and self-worth, and suicidal thoughts. To decrease the possible depression rates
several approaches were studied. Epidural analgesia is one of them. Epidural analgesia is a
commonly used method in the world to reduce the pain of the pregnant women during labor and is well tolerated by both the mother and the infant. In this study, our primary aim was that the women who had epidural labor analgesia would have lower depression severity scores in the sixth postpartum week. Our secondary aim was that those patients would have lower pain scores during the labor and in at 24th hour if they received epidural analgesia. Our study covered 6 months’ time. The patients were assigned to two groups. One group consisted of the women who gave birth without receiving an epidural analgesia and the other group consisted of women who gave birth with epidural analgesia. Prior to birth and in the 6th week after birth, depression scales were administered to all patients. The patients' severity of the pain was assessed by scales the labor and in the 24th hour postoperatively. In conclusion, our study identified favorable pain scores and lower depression severity in the 6th weeks after birth for patients who received epidural analgesia. In addition, we reported that the increased scores of pains at labor were correlated with postpartum depression. In the light of these results, we suggest that pregnant women should prefer epidural analgesia if they are going to give birth via the normal vaginal route.

Who can participate?
The women at 18-45 years of age, who would give birth electively via normal vaginal route with or without epidural analgesia, who had ASA scores of I-III, and who consented to participate were included in the study

What does the study involve?
Patients were divided into two groups. One group consisted of the women who gave birth without receiving an epidural analgesia and the other group consisted of women who gave birth with epidural analgesia. Prior to birth and in the 6th week after birth, depression scales were administered to all patients. The patients' severity of the pain was assessed by scales the labor and in the 24th hour postoperatively

What are the possible benefits and risks of participating?
There was no risk for the participants because it wats an observational study.

Where is the study run from?
İstanbul Education and Research Hospital, Istanbul (Turkey)

When is the study starting and how long is it expected to run for?
From 25/03/2018 to 25/10/2018

Who is funding the study?
İstanbul Education and Research Hospital, Istanbul

Who is the main contact?
Dr. İpek S. Edipoglu
dripeks@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ipek Saadet Edipoglu

ORCID ID

http://orcid.org/0000-0002-3510-5991

Contact details

Telsiz Mahallesi
Balıklı Kazlıçeşme Yolu Cd. No:1
Zeytinburnu/İstanbul
İstanbul
34020
Turkey

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A comparison of the severity of postpartum depression in women who gave normal vaginal birth with or without epidural analgesia: a prospective observational study

Acronym

Study hypothesis

Women who have epidural labour analgesia will have lower depression severity scores in the sixth postpartum week. Patients will have lower Visual Analogue Scale (VAS) scores in the 24th hour if they receive epidural analgesia during labour.

Ethics approval

Istanbul Training and Research Hospital Anesthesiology department institutional ethics committee approved the study, 08/02/2018.

Study design

Single centered, prospective, observational

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet’

Condition

Postpartum depression

Intervention

From the patients who agreed to participate, one group consisted of the women who gave birth without receiving an epidural analgesia and the other group consisted of women who gave birth with epidural analgesia. The total duration of observation and duration of the follow up was 6 weeks for all patient groups. Prior to birth and in the postpartum 6th week, Edinburgh postnatal depression scale was administered to all patients. The patients' severity of the pain was assessed by Visual analogue scale (VAS) during the labour and in the 24th hour postoperatively.

Intervention type

Drug

Phase

Not Applicable

Drug names

Primary outcome measure

Edinburgh postnatal depression scale scores prior to birth and in the postpartum 6th week,

Secondary outcome measures

Visual Analogue Scale (VAS) scores during labour and at 24th hour

Overall trial start date

25/02/2018

Overall trial end date

25/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women aged 18 to 45 years old.
2. Would give birth electively via normal vaginal route with or without epidural analgesia
3. ASA scores of I-III

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

88

Participant exclusion criteria

1. History of schizophrenia, bipolar disorder or obsessive-compulsive disorder in the pre-partum period.
2. Haematological disorders contraindicated for regional anaesthesia.
3. Skin infections in the lumbar area.
4. If the route of delivery was required to be switched to a cesarean section.

Recruitment start date

25/03/2018

Recruitment end date

25/10/2018

Locations

Countries of recruitment

Turkey

Trial participating centre

İstanbul eğitim ve araştırma hastanesi
Balıklı Kazlıçeşme Yolu Cd. No:1 Zeytinburnu
istanbul
34020
Turkey

Sponsor information

Organisation

istanbul eğitim ve araştırma hastanesi

Sponsor details

Telsiz Mahallesi
Balıklı Kazlıçeşme Yolu Cd. No:1
34020 Zeytinburnu/İstanbul
istanbul
34020
Turkey

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement: The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

25/11/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/12/2018: Internal review.