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

NCT ID: NCT02533167

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

Skin to Skin Contact in Cesarean Deliveries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

skin to skin

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

Group Type: EXPERIMENTAL

skin to skin

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashley Tonidandel, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00033101

Identifier Type: -

Identifier Source: org_study_id