Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Completed
NCT Number: NCT02533167
Impact of Skin to Skin Contact on Maternal Satisfaction, Pain Scores, and Narcotic Usage After Cesarean Delivery
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.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- non emergent cesarean deliveries term gestation age ASA I or II spinal anesthetic
Exclusion criteria
- contraindication to spinal anesthetic or to medications utilized emergence cesarean delivery under age 18 less than 37 weeks gestational age
Treatment and study plan
Skin to Skin
Otherinitiating 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.
Primary outcomes
-
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
Other outcomes
-
Morphine Usage
Time frame: up to 24 hours
24 hour morphine equivalents required in the operating room up to the initial 24 hours after delivery for pain management
-
Maternal Satisfaction With Anesthesia Care
Time frame: up to 24 hours
maternal satisfaction with anesthesia care will be evaluated on post delivery day 1 utilizing a 100mm sliding scale where VAS 0= not satisfied at all up to 100= extremely satisfied
-
Maternal Satisfaction With Pain Control in the Operating Room
Time frame: 24 hours
with pain control in the operating room will be evaluated on post delivery day 1 utilizing a 100mm sliding scale VAS 0= not satisfied at all up to 100= extremely satisfied
-
Maternal Satisfaction With Postoperative Pain Control
Time frame: 24 hours
with pain control at 24 hours postoperative will be evaluated on post delivery day 1 utilizing a 100mm sliding scale VAS 0= not satisfied at all up to 100= extremely satisfied
-
Maternal Satisfaction-operating Room
Time frame: 24 hours
maternal satisfaction with operating room atmosphere will be evaluated on post delivery day 1 utilizing a 100mm sliding scale VAS 0= not satisfied at all up to 100= extremely satisfied
Sponsors and collaborators
Lead sponsor
Wake Forest University Health Sciences
Other
Registry information
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Aug 26, 2015
- Registry last updated
- Sep 5, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Completed
The Effect of Paternal Skin-to-Skin Contact on Breastfeeding Process After Cesarean Section
NCT06646393
Behavior, Breast Feeding
Ağrı, Merkez, Turkey (Türkiye)
View Trial Details