NCT02495350

Brief Summary

In this study the investigators would like to evaluate how prelabor analgesic plan and actual labor analgesia effects the labor satisfaction, breastfeeding success, and whether or not it reduces postpartum depression. Although postpartum depression has been researched and reviewed, there is little information on how satisfaction during labor affects postpartum outcomes. The relationship between epidural analgesia is also complex, and there has yet to be found a valid correlation between the two parameters. In addition although an attempt has been made to evaluate relationship between breastfeeding and epidural analgesia, results are unclear and further research is needed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,954

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

June 17, 2015

Last Update Submit

November 16, 2017

Conditions

Depression, Postpartum

Outcome Measures

Primary Outcomes (1)

  • Assessment of postpartum depression using Edinborough Postnatal Depression scale

    One year

Secondary Outcomes (2)

  • Assessment of breast feeding duration in women undergoing vaginal deliveries

    one year

  • Increases in labor satisfaction defined as a vas (visual analog scale) satisfaction over 7 in women undergoing vaginal deliveries

    one year

Study Arms (4)

Initially didn't want an epidural and didn't receive one.

Initially didn't want an epidural and did receive one.

Initially wanted an epidural and didn't received one

Other: Questionarie

Initially wanted an epidural and did receive one.

Other: Questionarie

Interventions

QuestionarieOTHER

Parturients will be asked to fill out a labor satisfaction questionnaire detailing initial desire for epidural analgesia, final desire for epidural analgesia, adequacy of pain relief during labor and satisfaction with laborOn the third day postoperatively the parturients will be called and assessed for mood and signs of postpartum depression using Edinborough Postnatal Depression scale validated into Hebrew (10) , and we will assess whether or not they are breastfeeding. At 6 weeks we will follow-up to assess breastfeeding duration ,and postpartum depression using the Edinborough Postnatal Depression scale. Our comparison will include average pain scores, breast feeding success, and postpartum depression assessment.

Initially wanted an epidural and did receive one.Initially wanted an epidural and didn't received one

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women above 18 undergoing vaginal delivery in Beilinson Hospital

You may qualify if:

  • Women above 18 undergoing vaginal delivery in Beilinson Hospital
  • following obtaining written informed consents
  • ability to comply with the study requirements will be included in the investigators' study

You may not qualify if:

  • Women undergoing cesareans sections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beilinson hospital

Petach Tikvah, Israel

Location

Related Publications (12)

  • 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.

    PMID: 14995921BACKGROUND

  • 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.

    PMID: 24797120BACKGROUND

  • 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.

    PMID: 18818022BACKGROUND

  • Mauri PA, Contini NN, Giliberti S, Barretta F, Consonni D, Negri M, Di Benedetto I. Intrapartum epidural analgesia and onset of lactation: a prospective study in an Italian birth centre. Matern Child Health J. 2015 Mar;19(3):511-8. doi: 10.1007/s10995-014-1532-x.

    PMID: 24894732BACKGROUND

  • Henderson JJ, Dickinson JE, Evans SF, McDonald SJ, Paech MJ. Impact of intrapartum epidural analgesia on breast-feeding duration. Aust N Z J Obstet Gynaecol. 2003 Oct;43(5):372-7. doi: 10.1046/j.0004-8666.2003.t01-1-00117.x.

    PMID: 14717315BACKGROUND

  • Sheiner E, Shoham-Vardi I, Sheiner EK, Press F, Hackmon-Ram R, Mazor M, Katz M. A comparison between the effectiveness of epidural analgesia and parenteral pethidine during labor. Arch Gynecol Obstet. 2000 Feb;263(3):95-8. doi: 10.1007/s004040050003.

    PMID: 10763834BACKGROUND

  • Dickinson JE, Paech MJ, McDonald SJ, Evans SF. Maternal satisfaction with childbirth and intrapartum analgesia in nulliparous labour. Aust N Z J Obstet Gynaecol. 2003 Dec;43(6):463-8. doi: 10.1046/j.0004-8666.2003.00152.x.

    PMID: 14712952BACKGROUND

  • Kannan S, Jamison RN, Datta S. Maternal satisfaction and pain control in women electing natural childbirth. Reg Anesth Pain Med. 2001 Sep-Oct;26(5):468-72. doi: 10.1053/rapm.2001.24260.

    PMID: 11561269BACKGROUND

  • Shapiro A, Fredman B, Zohar E, Olsfanger D, Jedeikin R. Delivery room analgesia: an analysis of maternal satisfaction. Int J Obstet Anesth. 1998 Oct;7(4):226-30. doi: 10.1016/s0959-289x(98)80043-5.

    PMID: 15321184BACKGROUND

  • Glasser S, Barell V. [Depression scale for research in and identification of postpartum depression]. Harefuah. 1999 May 16;136(10):764-8, 844, 843. Hebrew.

    PMID: 10955108BACKGROUND

  • Glasser S, Barell V, Shoham A, Ziv A, Boyko V, Lusky A, Hart S. Prospective study of postpartum depression in an Israeli cohort: prevalence, incidence and demographic risk factors. J Psychosom Obstet Gynaecol. 1998 Sep;19(3):155-64. doi: 10.3109/01674829809025693.

    PMID: 9844846BACKGROUND

  • Orbach-Zinger S, Landau R, Davis A, Oved O, Caspi L, Fireman S, Fein S, Ioscovich A, Bracco D, Hoshen M, Eidelman LA. The Effect of Labor Epidural Analgesia on Breastfeeding Outcomes: A Prospective Observational Cohort Study in a Mixed-Parity Cohort. Anesth Analg. 2019 Sep;129(3):784-791. doi: 10.1213/ANE.0000000000003442.

    PMID: 31425221DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sharon Orbach

Study Record Dates

First Submitted

June 17, 2015

First Posted

July 13, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

IL(1)