Skin to Skin Contact in Cesarean Deliveries
Conditions
Brief 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. 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.
Interventions
OTHERskin to skin
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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Evoked Pain Scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Morphine Usage | 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 | 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 | 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 | 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 | 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 |
Countries
United States
Participant flow
Recruitment details
Subjects were approached in the preoperative holding room area regarding participation in this study. Subjects were electively scheduled to have a cesarean delivery with proposed healthy outcomes with term deliveries.
Participants by arm
| Arm | Count |
|---|---|
| Skin to Skin skin to skin initiated on all consented CS while in the operating room
skin to skin: 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. | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | Skin to Skin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
Primary
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
Time frame: up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skin to Skin | Maternal Evoked Pain Scores | 43.55 units on a scale | Standard Deviation 25.34 |
Other Pre-specified
Maternal Satisfaction-operating Room
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
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skin to Skin | Maternal Satisfaction-operating Room | 95.98 units on a scale | Standard Deviation 8.94 |
Other Pre-specified
Maternal Satisfaction With Anesthesia Care
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
Time frame: up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skin to Skin | Maternal Satisfaction With Anesthesia Care | 95.91 units on a scale | Standard Deviation 8.19 |
Other Pre-specified
Maternal Satisfaction With Pain Control in the Operating Room
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
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skin to Skin | Maternal Satisfaction With Pain Control in the Operating Room | 94.93 units on a scale | Standard Deviation 15.52 |
Other Pre-specified
Maternal Satisfaction With Postoperative Pain Control
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
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skin to Skin | Maternal Satisfaction With Postoperative Pain Control | 81.52 units on a scale | Standard Deviation 23.68 |
Other Pre-specified
Morphine Usage
24 hour morphine equivalents required in the operating room up to the initial 24 hours after delivery for pain management
Time frame: up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skin to Skin | Morphine Usage | 21.83 mg of morphine | Standard Deviation 19.78 |