Skin to Skin Contact in Cesarean DeliveriesNCT02533167
Impact of Skin to Skin Contact on Maternal Satisfaction, Pain Scores, and Narcotic Usage After Cesarean Delivery
A study testing skin to skin in people with Skin to Skin Contact in Cesarean Deliveries, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Early skin to skin contact has beneficial effects and is part of the Healthy Birth Initiative. Positive effects on breast feeding, cardiorespiratory status, blood glucose control, and temperature has been demonstrated. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Skin to Skin Contact in Cesarean Deliveries
- What is being tested?
- skin to skin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- non emergent cesarean deliveries term gestation age ASA I or II spinal anesthetic
Who cannot join
- contraindication to spinal anesthetic or to medications utilized emergence cesarean delivery under age 18 less than 37 weeks gestational age
Trial locations and contacts
1 site in 1 country.
United States1 site
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Early skin to skin contact has beneficial effects and is part of the Healthy Birth Initiative. Positive effects on breast feeding, cardiorespiratory status, blood glucose control, and temperature has been demonstrated. It is the standard of care for vaginal deliveries but surgery is a barrier in its initiation in the operating room. This study is evaluating initiating skin to skin contact as soon as feasible in the operating room. Informed consent will be obtained from scheduled/non emergent cesarean sections who are of EGA.37 weeks who are ASA I-II and receiving the standard spinal anesthetic. Skin to skin contact will be initiated after delivery as soon as apgars and newborn assessment has been completed. Goal is a minimum of 60 minutes of skin to skin contact between the mother and the newborn, with the only interruption being upon movement from the OR table to the stretcher when leaving the OR. Subjects seen post delivery day 1 for assessments of pain and maternal satisfaction utilizing a sliding 100mm VAS assessment tool.
Read the detailed description
Initiation of skin to skin contact between the mother and the baby will be done in the operating room during surgery rather than waiting until the recovery room as is our standard of care. After assurance that both mom and newborn are stable, the newborn will be placed across the mother's chest and covered with a blanket to help maintain body temperature. The skin to skin contact is maintained throughout the remaining surgical time and then continued into the recovery room. The subjects are seen post delivery day 1 for evaluation of their pain and satisfaction with care using a 0-100mm sliding VAS scale, with 0=not satisfied at all or no pain at all through 100 = total satisfaction and most severe pain ever.
- Being tested
- skin to skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin to skinOther
initiating skin to skin is not currently the standard of care at our facility so there is 1 interventional arm for this study. control group of no skin to skin until recovery room already established as is the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| skin to skin | Experimental | skin to skin initiated on all consented CS while in the operating room Receives: Other: skin to skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Evoked Pain Scores
maternal evoked pain is evaluated utilizing a 100 mm Sliding VAS scale with 0=no pain through 100=most severe pain ever
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin to Skin Contact in Cesarean DeliveriesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley Tonidandel, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533167
- Sponsor's protocol ID
- IRB00033101
- Status last verified
- Aug 2018
- First submitted
- 19 Aug 2015
- Last updated
- 5 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Skin to Skin Contact on Maternal Satisfaction, Pain Scores, and Narcotic Usage After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02533167
- Acronym / sponsor ID
- IRB00033101
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Posted 6 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early skin to skin contact has beneficial effects and is part of the Healthy Birth Initiative. Positive effects on breast feeding, cardiorespiratory status, blood glucose control, and temperature has been demonstrated. It is the standard of care for vaginal deliveries but surgery is a barrier in its initiation in the operating room. This study is evaluating initiating skin to skin contact as soon as feasible in the operating room. Informed consent will be obtained from scheduled/non emergent cesarean sections who are of EGA.37 weeks who are ASA I-II and receiving the standard spinal anesthetic. Skin to skin contact will be initiated after delivery as soon as apgars and newborn assessment has been completed. Goal is a minimum of 60 minutes of skin to skin contact between the mother and the newborn, with the only interruption being upon movement from the OR table to the stretcher when leaving the OR. Subjects seen post delivery day 1 for assessments of pain and maternal satisfaction utilizing a sliding 100mm VAS assessment tool.
Detailed description
Initiation of skin to skin contact between the mother and the baby will be done in the operating room during surgery rather than waiting until the recovery room as is our standard of care. After assurance that both mom and newborn are stable, the newborn will be placed across the mother's chest and covered with a blanket to help maintain body temperature. The skin to skin contact is maintained throughout the remaining surgical time and then continued into the recovery room. The subjects are seen post delivery day 1 for evaluation of their pain and satisfaction with care using a 0-100mm sliding VAS scale, with 0=not satisfied at all or no pain at all through 100 = total satisfaction and most severe pain ever.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| skin to skin | Experimental | Other: skin to skinskin to skin initiated on all consented CS while in the operating room |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- non emergent cesarean deliveries term gestation age ASA I or II spinal anesthetic
Key exclusion criteria (1 listed)
- contraindication to spinal anesthetic or to medications utilized emergence cesarean delivery under age 18 less than 37 weeks gestational age
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 |
|---|---|---|
| skin to skininitiating skin to skin is not currently the standard of care at our facility so there is 1 interventional arm for this study. control group of no skin to skin until recovery room already established as is the standard of care. | Other | skin to skin |
Primary outcome
Maternal Evoked Pain Scores
Time frame: up to 24 hours
maternal evoked pain is evaluated utilizing a 100 mm Sliding VAS scale with 0=no pain through 100=most severe pain ever
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Neonatal Adaptation
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Effect of Combined Skin-to-Skin Contact and Kangaroo Care on Breastfeeding and Bonding in Cesarean-Born Newborns
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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.
Ashley Tonidandel, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin to skin in people with Skin to Skin Contact in Cesarean Deliveries, run by Wake Forest University Health Sciences 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 1 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 5 Sep 2018. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maternal Evoked Pain Scores (time frame: up to 24 hours). 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 5 Sep 2018.