PainNCT01417260
Effects of Breast Feeding on Post-Cesarean and Post-Vaginal Delivery Pain
An observational study of Pain, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pain
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2014
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 30 patients posy cesarean delivery. 100 patients post vaginal delivery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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.
Read the 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.
- Conditions
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nocebo | Told breastfeeding may worsen pain | |
| No treatment | Told nothing | |
| Placebo | Told will improve pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks post-delivery
Secondary outcomes (2)
To determine the effects of suggestion and mood on pain
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.
Measured: 6wks
To understand patients' preference for duration versus intensity of pain
We will also determine pain preferences as relating to pain intensity and duration by another questionnaire we have developed.
Measured: 48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brendan Carvalho, Stanford University
- Investigators
- Brendan Carvalho, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417260
- Sponsor's protocol ID
- SU-08092011-8247
- Other IDs
- IRB 22053
- Status last verified
- Apr 2015
- First submitted
- 11 Aug 2011
- Last updated
- 14 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breast Feeding on Post-Cesarean and Post-Vaginal Delivery Pain
- ClinicalTrials.gov ID
- NCT01417260
- Acronym / sponsor ID
- SU-08092011-8247
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Aug 2011 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nocebo | – | –Told breastfeeding may worsen pain |
| No treatment | – | –Told nothing |
| Placebo | – | –Told will improve pain |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 30 patients posy cesarean delivery. 100 patients post vaginal delivery.
Key inclusion criteria (6 listed)
- Age 18 - 40 yrs
- ASA 1 or 2
- Singleton gestation
- Greater or equal to 37 weeks gestation
- Vaginal delivery
Key exclusion criteria (8 listed)
- Chronic pain
- Patients prescribed regular analgesia medication ante-natally
- Substance abuse
- Classical cesarean incision
- Emergency cesarean delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain in relation to breastfeeding
Time frame: 6 weeks 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.
2 secondary outcomes
To determine the effects of suggestion and mood on pain
Time frame: 6wks
To understand patients' preference for duration versus intensity of pain
Time frame: 48 h
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 14 Apr 2015.
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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.
Brendan Carvalho principal investigator
Stanford University
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 Pain, run by Stanford University at 1 site in United States.
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 6 inclusion and 8 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 14 Apr 2015. 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 United States. 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?
Pain in relation to breastfeeding (time frame: 6 weeks post-delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2015.