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

NCT02533167 | Completed Results DMC

• 1 other identifier: IRB00033101
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin to Skin Contact in Cesarean Deliveries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Morphine Usage

  up to 24 hours

• Maternal Satisfaction With Anesthesia Care

  up to 24 hours

• Maternal Satisfaction With Pain Control in the Operating Room

  24 hours

Study Arms (1)

skin to skin

EXPERIMENTAL

skin to skin initiated on all consented CS while in the operating room

Other: skin to skin

Interventions

skin to skin OTHER

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.

skin to skin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• non emergent cesarean deliveries term gestation age ASA I or II spinal anesthetic

You may not qualify if:

• contraindication to spinal anesthetic or to medications utilized emergence cesarean delivery under age 18 less than 37 weeks gestational age

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Results Point of Contact

• Title: Ashley Tonidandel, MD
• Organization: Wake Forest Health Sciences

atonidan@wakehealth.edu

336-718-8278

Study Officials

• Ashley Tonidandel, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 26, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 5, 2018
• Results First Posted: August 6, 2018

Record last verified: 2018-08

Locations

US (1)