Trial Outcomes & Findings for Impact of Skin to Skin Contact on Maternal Satisfaction, Pain Scores, and Narcotic Usage After Cesarean Delivery (NCT NCT02533167)

Results Overview

maternal evoked pain is evaluated utilizing a 100 mm Sliding VAS scale with 0=no pain through 100=most severe pain ever

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

up to 24 hours

Results posted on

2018-09-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	70
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Skin to Skin Contact on Maternal Satisfaction, Pain Scores, and Narcotic Usage After Cesarean Delivery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Skin to Skin n=55 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Skin to Skin n=55 Participants 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.
Maternal Evoked Pain Scores	43.55 units on a scale Standard Deviation 25.34

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 24 hours

24 hour morphine equivalents required in the operating room up to the initial 24 hours after delivery for pain management

Outcome measures

Outcome measures
Measure	Skin to Skin n=55 Participants 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.
Morphine Usage	21.83 mg of morphine Standard Deviation 19.78

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Skin to Skin n=55 Participants 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.
Maternal Satisfaction With Anesthesia Care	95.91 units on a scale Standard Deviation 8.19

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Skin to Skin n=55 Participants 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.
Maternal Satisfaction With Pain Control in the Operating Room	94.93 units on a scale Standard Deviation 15.52

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Skin to Skin n=55 Participants 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.
Maternal Satisfaction With Postoperative Pain Control	81.52 units on a scale Standard Deviation 23.68

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Skin to Skin n=55 Participants 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.
Maternal Satisfaction-operating Room	95.98 units on a scale Standard Deviation 8.94

Adverse Events

Skin to Skin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ashley Tonidandel, MD

Wake Forest Health Sciences

Phone: 336-718-8278

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place