Clinical trial NCT02533167: Impact of Skin to Skin Contact on Maternal Satisfaction, Pain Scores, and Narcotic Usage After Cesarean Delivery
Official title: Impact of Skin to Skin Contact on Maternal Satisfaction, Pain Scores, and Narcotic Usage After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin to Skin Contact in Cesarean Deliveries
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Maternal Evoked Pain Scores
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
measure: Morphine Usage
timeFrame: up to 24 hours
measure: Maternal Satisfaction With Anesthesia Care
timeFrame: up to 24 hours
measure: Maternal Satisfaction With Pain Control in the Operating Room
timeFrame: 24 hours
measure: Maternal Satisfaction With Postoperative Pain Control
timeFrame: 24 hours
measure: Maternal Satisfaction-operating Room
timeFrame: 24 hours
Locations:
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ashley Tonidandel, MD
role: PRINCIPAL_INVESTIGATOR
References: