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.

Study Overview

• Status: Completed
• Conditions: Skin to Skin Contact in Cesarean Deliveries
• Intervention / Treatment: Other: skin to skin

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: skin to skin; skin to skin initiated on all consented CS while in the operating room	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Usage	24 hour morphine equivalents required in the operating room up to the initial 24 hours after delivery for pain management	up to 24 hours
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	up to 24 hours
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	24 hours
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	24 hours
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	24 hours

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Ashley Tonidandel, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: August 19, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (ESTIMATE): August 26, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IRB00033101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No