Effects of Breast Feeding on Post-Cesarean and Post-Vaginal Delivery Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Brendan Carvalho, Stanford University
ClinicalTrials.gov Identifier:
NCT01417260
First received: August 11, 2011
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

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.


Condition
Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Breast Feeding on Post-Cesarean and Post-Vaginal Delivery Pain

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Pain in relation to breastfeeding [ Time Frame: 6 weeks post-delivery ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • To determine the effects of suggestion and mood on pain [ Time Frame: 6wks ] [ Designated as safety issue: No ]

    Secondary outcome measure will include: Depression, PTDS, and other outcome measures. Patients will also be asked to complete pain intensity and depression (The Edinburgh Depression Scale) and a PTSD questionnaires. We will determine the effects of suggestion (placebo vs. nocebo) on the pain experience.

    At 6 weeks post-delivery, a member of the research team will call the participant to ask questions regarding current pain scores, success of breastfeeding and weight of the baby.

    The study end-point is 6 weeks post-delivery.


  • To understand patients' preference for duration versus intensity of pain [ Time Frame: 48 h ] [ Designated as safety issue: No ]
    We will also determine pain preferences as relating to pain intensity and duration by another questionnaire we have developed.


Estimated Enrollment: 130
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Nocebo
Told breastfeeding may worsen pain
No treatment
Told nothing
Placebo
Told will improve pain

Detailed Description:

Patients will be recruited by a member of the research team when the patient is admitted to labor or delivery and when they are in the post-natal floor.

Patients will be divided into two groups initially depending on mode of delivery, vaginal vs. cesarean. The vaginal delivery group will be randomized into three groups. One group will be told that we are investigating the effect of oxytocin on pain intensity, the second group will be told that it reduces pain intensity, the third group will be told that it increases pain intensity.

The cesarean group are not going to be randomized, they will be told we are investigating the effect of oxytocin on pain intensity.

Demographic and obstetric will be collected by patient questioning as well as from the medical record on Day 1 post delivery. Analgesia data from the medical record will also be collected on days 1 and 2 post-delivery.

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.

Secondary outcome measure will include: Depression, PTDS, and other outcome measures. Patients will also be asked to complete pain intensity and depression (The Edinburgh Depression Scale) and a PTSD questionnaires. We will also determine pain preferences as relating to pain intensity and duration by another questionnaire.

At 6 weeks post-delivery, a member of the research team will call the participant to ask questions regarding current pain scores, success of breastfeeding and weight of the baby.

The study end-point is 6 weeks post-delivery. We will debrief participants who had deception at completion of the whole study.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

30 patients posy cesarean delivery. 100 patients post vaginal delivery.

Criteria

Inclusion Criteria:

  1. Age 18 - 40 yrs
  2. ASA 1 or 2
  3. Singleton gestation
  4. Greater or equal to 37 weeks gestation
  5. Vaginal delivery
  6. Scheduled cesarean delivery with a Pfannenstiel incision

Exclusion Criteria:

  1. Chronic pain
  2. Patients prescribed regular analgesia medication ante-natally
  3. Substance abuse
  4. Classical cesarean incision
  5. Emergency cesarean delivery
  6. Patients not planning to breastfeed
  7. Psychiatric or cognitive disorder, including anxiety or depression
  8. Physicians, labor and delivery nurses, midwives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417260

Contacts
Contact: Brendan Carvalho (650) 861-8607 bcarvalho@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Brendan Carvalho    650-861-8607    bcarvalho@stanford.edu   
Contact: Gillian Hilton       ghilton@stanford.edu   
Principal Investigator: Brendan Carvalho         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Brendan Carvalho Stanford University
  More Information

No publications provided

Responsible Party: Brendan Carvalho, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01417260     History of Changes
Other Study ID Numbers: SU-08092011-8247, IRB 22053
Study First Received: August 11, 2011
Last Updated: June 8, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 29, 2014