Trial Outcomes & Findings for The Effect of Video Education on Skin-to-Skin at the Time of Delivery (NCT NCT03200925)
NCT ID: NCT03200925
Last Updated: 2019-08-02
Results Overview
Both groups will be asked a short survey at the time of admission: * their intention to practice skin to skin at the time of delivery * if they participated in skin to skin in a previous pregnancy * if they had any formal education about skin to skin * if they did have formal education was it either * a.) Provided at a prenatal appointment * b.) A formal class led by either a nurse or a lactation consultant Group B will watch a short video about skin-to-skin contact and will be then reasked a question regarding their intention to practice skin-to-skin contact after birth. This information will allow us to determine if video education impacts the intention to practice skin-to-skin contact after birth.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
1 day
Results posted on
2019-08-02
Participant Flow
Participant milestones
| Measure |
Group A - no Video Group
Group A will be asked a short survey:
* their intention to practice skin to skin at the time of delivery
* if they participated in skin to skin in a previous pregnancy
* if they had any formal education about skin to skin
* if they did have formal education was it either
* a.) Provided at a prenatal appointment,
* b.) A formal class led by either a nurse or a lactation consultant.
We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).
|
Group B - Video Group
Group B will be asked the same short survey as group A. The patient would then immediately watch "Jumping into Kangaroo Care", and then immediately take the post survey which would ask if they intended to practice skin to skin at the time of delivery.We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
|
Overall Study
COMPLETED
|
120
|
120
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Video Education on Skin-to-Skin at the Time of Delivery
Baseline characteristics by cohort
| Measure |
Group A - no Video Group
n=120 Participants
Group A will be asked a short survey:
* their intention to practice skin to skin at the time of delivery
* if they participated in skin to skin in a previous pregnancy
* if they had any formal education about skin to skin
* if they did have formal education was it either
* a.) Provided at a prenatal appointment,
* b.) A formal class led by either a nurse or a lactation consultant.
We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).
|
Group B - Video Group
n=120 Participants
Group B will be asked the same short survey as group A. The patient would then immediately watch "Jumping into Kangaroo Care", and then immediately take the post survey which would ask if they intended to practice skin to skin at the time of delivery.We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 5.5 • n=99 Participants
|
27 years
STANDARD_DEVIATION 5.1 • n=107 Participants
|
27 years
STANDARD_DEVIATION 5.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
240 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
90 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
188 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
22 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Primiparous
|
53 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Private Insurance
|
55 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Medicaid
|
61 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Comorbidities
Chronic Hypertension
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Comorbidities
Gestational Hypertension
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Comorbidities
Preeclampsia
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Comorbidities
Gestational Diabetes Mellitus
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Comorbidities
Asthma
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Comorbidities
Neurologic Disease
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Comorbidities
Hematologic Disease
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Comorbidities
Other Medical Comorbitities
|
40 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Obstetric Measures
Spontaneous Vaginal Delivery
|
84 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
173 Participants
n=206 Participants
|
|
Obstetric Measures
Vacuum Delivery
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Obstetric Measures
Low Transverse Cesarean Delivery
|
25 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Gestational Age (weeks)
|
39 weeks
n=99 Participants
|
39 weeks
n=107 Participants
|
39 weeks
n=206 Participants
|
|
5 Minute APGAR Score
|
9 units on a scale
n=99 Participants
|
9 units on a scale
n=107 Participants
|
9 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 dayBoth groups will be asked a short survey at the time of admission: * their intention to practice skin to skin at the time of delivery * if they participated in skin to skin in a previous pregnancy * if they had any formal education about skin to skin * if they did have formal education was it either * a.) Provided at a prenatal appointment * b.) A formal class led by either a nurse or a lactation consultant Group B will watch a short video about skin-to-skin contact and will be then reasked a question regarding their intention to practice skin-to-skin contact after birth. This information will allow us to determine if video education impacts the intention to practice skin-to-skin contact after birth.
Outcome measures
| Measure |
Group A - no Video Group
n=120 Participants
Group A will be asked a short survey:
* their intention to practice skin to skin at the time of delivery
* if they participated in skin to skin in a previous pregnancy
* if they had any formal education about skin to skin
* if they did have formal education was it either
* a.) Provided at a prenatal appointment,
* b.) A formal class led by either a nurse or a lactation consultant.
We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).
|
Group B - Video Group
n=120 Participants
Group B will be asked the same short survey as group A. The patient would then immediately watch "Jumping into Kangaroo Care", and then immediately take the post survey which would ask if they intended to practice skin to skin at the time of delivery.We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).
|
|---|---|---|
|
Intention to Practice Skin-to-skin Contact After Birth
Pre-Intervention (video)
|
100 Participants
|
107 Participants
|
|
Intention to Practice Skin-to-skin Contact After Birth
Post-Intervention
|
NA Participants
Did not have intervention.
|
118 Participants
|
PRIMARY outcome
Timeframe: 1 weekFor both video and non-video groups, skin to skin duration (minutes) after delivery will be calculated. The time in minutes from delivery to initiation of skin to skin contact is also collected. This information will allow us to determine if video education impacts the actual practice of skin-to-skin contact after birth.
Outcome measures
| Measure |
Group A - no Video Group
n=120 Participants
Group A will be asked a short survey:
* their intention to practice skin to skin at the time of delivery
* if they participated in skin to skin in a previous pregnancy
* if they had any formal education about skin to skin
* if they did have formal education was it either
* a.) Provided at a prenatal appointment,
* b.) A formal class led by either a nurse or a lactation consultant.
We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).
|
Group B - Video Group
n=120 Participants
Group B will be asked the same short survey as group A. The patient would then immediately watch "Jumping into Kangaroo Care", and then immediately take the post survey which would ask if they intended to practice skin to skin at the time of delivery.We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).
|
|---|---|---|
|
Actual Practice of Skin-to-skin Contact After Birth
Delivery to Skin to Skin Contact
|
6 minutes
Interval 0.0 to 39.0
|
3 minutes
Interval 0.0 to 26.0
|
|
Actual Practice of Skin-to-skin Contact After Birth
Skin to Skin Duration
|
88 minutes
Interval 17.0 to 161.0
|
91 minutes
Interval 13.0 to 210.0
|
POST_HOC outcome
Timeframe: Prior to admission for deliveryMeasuring formal education training about skin to skin contact prior to admission, provided at either a prenatal appointment or a formal class led by either a nurse or a lactation consultant.
Outcome measures
| Measure |
Group A - no Video Group
n=120 Participants
Group A will be asked a short survey:
* their intention to practice skin to skin at the time of delivery
* if they participated in skin to skin in a previous pregnancy
* if they had any formal education about skin to skin
* if they did have formal education was it either
* a.) Provided at a prenatal appointment,
* b.) A formal class led by either a nurse or a lactation consultant.
We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).
|
Group B - Video Group
n=120 Participants
Group B will be asked the same short survey as group A. The patient would then immediately watch "Jumping into Kangaroo Care", and then immediately take the post survey which would ask if they intended to practice skin to skin at the time of delivery.We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).
|
|---|---|---|
|
Number of Participants With Formal Education About Skin to Skin Contact
|
40 Participants
|
38 Participants
|
Adverse Events
Group A - no Video Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B - Video Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place