Effects of Breast Feeding on Post-Cesarean and Post-Vaginal Delivery Pain
2 other identifiers
observational
130
1 country
1
Brief Summary
Oxytocin is a hormone that is released in response to distension of the cervix and uterus during labor, and after breast feeding as a result of nipple stimulation. In addition to oxytocin facilitating birth and breastfeeding, oxytocin has a number of effects on maternal behavior including bonding, social recognition, anxiolysis, sexual arousal. The role of oxytocin in pain modulation has recently been highlighted. Intranasal or intrathecal (spinal) administration has been found to impact pain modulation. The administration of intravenous oxytocin has not provided effective analgesia because oxytocin is unable to pass to your brain. The role of breastfeeding on analgesia is poorly investigated, which is why we are carrying out this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 11, 2011
CompletedFirst Posted
Study publicly available on registry
August 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 14, 2015
April 1, 2015
3.3 years
August 11, 2011
April 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Pain in relation to breastfeeding
The primary outcome measure will be change in pain scores (0=no pain, 10=worse pain imaginable) during and after breastfeeding compared to pain before. We will examine both vaginal, cramping and surgical pain as appropriate. The patients will be given a breastfeeding diary to complete, which will record the average pain scores (0-10) before, during and after each breastfeed.
6 weeks post-delivery
Secondary Outcomes (2)
To determine the effects of suggestion and mood on pain
6wks
To understand patients' preference for duration versus intensity of pain
48 h
Study Arms (3)
Nocebo
Told breastfeeding may worsen pain
No treatment
Told nothing
Placebo
Told will improve pain
Eligibility Criteria
30 patients posy cesarean delivery. 100 patients post vaginal delivery.
You may qualify if:
- Age 18 - 40 yrs
- ASA 1 or 2
- Singleton gestation
- Greater or equal to 37 weeks gestation
- Vaginal delivery
- Scheduled cesarean delivery with a Pfannenstiel incision
You may not qualify if:
- Chronic pain
- Patients prescribed regular analgesia medication ante-natally
- Substance abuse
- Classical cesarean incision
- Emergency cesarean delivery
- Patients not planning to breastfeed
- Psychiatric or cognitive disorder, including anxiety or depression
- Physicians, labor and delivery nurses, midwives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brendan Carvalho
Stanford University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 11, 2011
First Posted
August 16, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
April 14, 2015
Record last verified: 2015-04