Depression, PostpartumNCT02495350
The Correlation Between Prelabor Analgesic Plan and Actual Labor Analgesia With Satisfaction, Postpartum Depression, and Breast Feeding Success
An observational study of Depression, Postpartum, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- Questionarie
- How many people
- 1,954 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2015to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women above 18 undergoing vaginal delivery in Beilinson Hospital
Who may be able to join
- 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
Who cannot join
- Women undergoing cesareans sections.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This is a prospective, single center study, which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital.
All women undergoing vaginal delivery on the first day postpartum will be enrolled after filling out an informed consent.
They will be given 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 labor. (see appendix 1).
The investigators will evaluate breastfeeding success according to the latch scoring system in the first day postpartum which is routinely administered by nurses/ lactation consultants in the maternity ward.
According to their initial desire verses final analgesic choice they will be divided into four groups:
- Women who initially didn't want and didn't receive one.
- Initially didn't want and did receive one.
- Initially wanted an epidural and didn't received one
- Initially wanted an epidural and did receive one.
On 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 the investigators will assess whether or not they are breastfeeding.
At 6 weeks the investigators will follow-up to assess breastfeeding duration ,and postpartum depression using the Edinborough Postnatal Depression scale.
The investigators' comparison will include average pain scores, breast feeding success, and postpartum depression assessment.
- Conditions
- Depression, Postpartum
- Being tested
- Questionarie
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Initially didn't want an epidural and didn't receive one. | Not described | |
| Initially didn't want an epidural and did receive one. | Not described | |
| Initially wanted an epidural and didn't received one | Not described Receives: Other: Questionarie | |
| Initially wanted an epidural and did receive one. | Not described Receives: Other: Questionarie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of postpartum depression using Edinborough Postnatal Depression scale
Measured: One year
Secondary outcomes (2)
Assessment of breast feeding duration in women undergoing vaginal deliveries
Measured: one year
Increases in labor satisfaction defined as a vas (visual analog scale) satisfaction over 7 in women undergoing vaginal deliveries
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,954 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sharonorbach, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495350
- Sponsor's protocol ID
- 0666-14-RMC
- Status last verified
- Nov 2017
- First submitted
- 17 Jun 2015
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14995921Ding 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.
PubMed 24797120Eisenach 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.
PubMed 18818022Mauri 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.
PubMed 24894732Henderson 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.
PubMed 14717315Sheiner 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.
PubMed 10763834Dickinson 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.
PubMed 14712952Kannan 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.
PubMed 11561269Shapiro 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.
PubMed 15321184Glasser S, Barell V. [Depression scale for research in and identification of postpartum depression]. Harefuah. 1999 May 16;136(10):764-8, 844, 843. Hebrew.
PubMed 10955108Glasser 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.
PubMed 9844846Orbach-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.
PubMed 31425221
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Prelabor Analgesic Plan and Actual Labor Analgesia With Satisfaction, Postpartum Depression, and Breast Feeding Success
- ClinicalTrials.gov ID
- NCT02495350
- Acronym / sponsor ID
- 0666-14-RMC
- Conditions
- Depression, Postpartum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,954 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single center study, which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital.
All women undergoing vaginal delivery on the first day postpartum will be enrolled after filling out an informed consent.
They will be given 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 labor. (see appendix 1).
The investigators will evaluate breastfeeding success according to the latch scoring system in the first day postpartum which is routinely administered by nurses/ lactation consultants in the maternity ward.
According to their initial desire verses final analgesic choice they will be divided into four groups:
- Women who initially didn't want and didn't receive one.
- Initially didn't want and did receive one.
- Initially wanted an epidural and didn't received one
- Initially wanted an epidural and did receive one.
On 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 the investigators will assess whether or not they are breastfeeding.
At 6 weeks the investigators will follow-up to assess breastfeeding duration ,and postpartum depression using the Edinborough Postnatal Depression scale.
The investigators' comparison will include average pain scores, breast feeding success, and postpartum depression assessment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women above 18 undergoing vaginal delivery in Beilinson Hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Women undergoing cesareans sections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionarieParturients 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. | Other | Initially wanted an epidural and did receive one., Initially wanted an epidural and didn't received one |
Primary outcome
Assessment of postpartum depression using Edinborough Postnatal Depression scale
Time frame: One year
2 secondary outcomes
Assessment of breast feeding duration in women undergoing vaginal deliveries
Time frame: one year
Increases in labor satisfaction defined as a vas (visual analog scale) satisfaction over 7 in women undergoing vaginal deliveries
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Background: PubMed 14995921Hiltunen 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.
- Background: PubMed 24797120Ding 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.
- Background: PubMed 18818022Eisenach 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.
- Background: PubMed 24894732Mauri 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.
- Background: PubMed 14717315Henderson 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.
- Background: PubMed 10763834Sheiner 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.
- Background: PubMed 14712952Dickinson 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.
- Background: PubMed 11561269Kannan 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.
- Background: PubMed 15321184Shapiro 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.
- Background: PubMed 10955108Glasser S, Barell V. [Depression scale for research in and identification of postpartum depression]. Harefuah. 1999 May 16;136(10):764-8, 844, 843. Hebrew.
- Background: PubMed 9844846Glasser 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.
- Derived from this study: PubMed 31425221Orbach-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Postpartum, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of postpartum depression using Edinborough Postnatal Depression scale (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02495350, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.