Trial Outcomes & Findings for Family-Centered Cesarean Delivery (NCT NCT02690077)
NCT ID: NCT02690077
Last Updated: 2024-10-03
Results Overview
The primary objective of this study was to compare satisfaction with birthing experiences between women who underwent either a family-centered or traditional cesarean delivery, using a modified Likert scale, ranging from 1 (lowest) to 5 (highest).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
149 participants
Primary outcome timeframe
Assessed at time of discharge from the hospital (typically 3-5 days post-delivery)
Results posted on
2024-10-03
Participant Flow
Participant milestones
| Measure |
Method 1 (Family-Centered Cesarean)
Delivery through the Family-Centered Cesarean.
Family-Centered Cesarean: Procedure involves lowering part of the surgical drape exposing a transparent window through which the mother can watch the birth of her baby; the baby will be placed on her chest immediately after the delivery. Cleaning and evaluation of the baby will be done by a nurse who is standing at the head of the bed.
|
Method 2 (Traditional Cesarean)
Delivery through the Traditional Cesarean.
Traditional Cesarean: Procedure involves keeping the surgical drape up throughout the entire surgery so that the birthing process will not be visible to the mother, and the baby will be taken to the warmer to be evaluated and cleaned after birth but is available to be laid on the mother's chest at any point upon request.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
76
|
|
Overall Study
COMPLETED
|
68
|
61
|
|
Overall Study
NOT COMPLETED
|
5
|
15
|
Reasons for withdrawal
| Measure |
Method 1 (Family-Centered Cesarean)
Delivery through the Family-Centered Cesarean.
Family-Centered Cesarean: Procedure involves lowering part of the surgical drape exposing a transparent window through which the mother can watch the birth of her baby; the baby will be placed on her chest immediately after the delivery. Cleaning and evaluation of the baby will be done by a nurse who is standing at the head of the bed.
|
Method 2 (Traditional Cesarean)
Delivery through the Traditional Cesarean.
Traditional Cesarean: Procedure involves keeping the surgical drape up throughout the entire surgery so that the birthing process will not be visible to the mother, and the baby will be taken to the warmer to be evaluated and cleaned after birth but is available to be laid on the mother's chest at any point upon request.
|
|---|---|---|
|
Overall Study
Excluded from analyses for no OR worksheet or questionnaire completed
|
5
|
8
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
|
Overall Study
Excluded by IRB
|
0
|
2
|
Baseline Characteristics
Family-Centered Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Method 1 (Family Centered Cesarean)
n=68 Participants
Delivery through the Family-Centered Cesarean.
Family-Centered Cesarean: Procedure involves lowering part of the surgical drape exposing a transparent window through which the mother can watch the birth of her baby; the baby will be placed on her chest immediately after the delivery. Cleaning and evaluation of the baby will be done by a nurse who is standing at the head of the bed.
|
Method 2 (Traditional Cesarean)
n=61 Participants
Delivery through the Traditional Cesarean.
Traditional Cesarean: Procedure involves keeping the surgical drape up throughout the entire surgery so that the birthing process will not be visible to the mother, and the baby will be taken to the warmer to be evaluated and cleaned after birth but is available to be laid on the mother's chest at any point upon request.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.9 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
29.5 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
29.2 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black non-Hispanic
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at time of discharge from the hospital (typically 3-5 days post-delivery)The primary objective of this study was to compare satisfaction with birthing experiences between women who underwent either a family-centered or traditional cesarean delivery, using a modified Likert scale, ranging from 1 (lowest) to 5 (highest).
Outcome measures
| Measure |
Method 1 (Family-Centered Cesarean)
n=68 Participants
Delivery through the Family-Centered Cesarean.
Family-Centered Cesarean: Procedure involves lowering part of the surgical drape exposing a transparent window through which the mother can watch the birth of her baby; the baby will be placed on her chest immediately after the delivery. Cleaning and evaluation of the baby will be done by a nurse who is standing at the head of the bed.
|
Method 2 (Traditional Cesarean)
n=61 Participants
Delivery through the Traditional Cesarean.
Traditional Cesarean: Procedure involves keeping the surgical drape up throughout the entire surgery so that the birthing process will not be visible to the mother, and the baby will be taken to the warmer to be evaluated and cleaned after birth but is available to be laid on the mother's chest at any point upon request.
|
|---|---|---|
|
11-item Patient Satisfaction Questionnaire
How satisfied were you with your involvement with the delivery of the baby?
|
4.6 units on a scale
Standard Deviation 0.8
|
4.4 units on a scale
Standard Deviation 0.9
|
|
11-item Patient Satisfaction Questionnaire
Did the method for delivery meet your expectations?
|
4.6 units on a scale
Standard Deviation 0.7
|
4.3 units on a scale
Standard Deviation 1.0
|
|
11-item Patient Satisfaction Questionnaire
Based on previous cesarean delivery how satisfied are you with the method of delivery of your baby?
|
4.9 units on a scale
Standard Deviation 0.7
|
4.7 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Assessed in Operating RoomThe secondary objective of this study is to determine if there is a difference in time-to-initiation of family bond between the family-centered cesarean delivery method and traditional cesarean delivery method.
Outcome measures
| Measure |
Method 1 (Family-Centered Cesarean)
n=68 Participants
Delivery through the Family-Centered Cesarean.
Family-Centered Cesarean: Procedure involves lowering part of the surgical drape exposing a transparent window through which the mother can watch the birth of her baby; the baby will be placed on her chest immediately after the delivery. Cleaning and evaluation of the baby will be done by a nurse who is standing at the head of the bed.
|
Method 2 (Traditional Cesarean)
n=61 Participants
Delivery through the Traditional Cesarean.
Traditional Cesarean: Procedure involves keeping the surgical drape up throughout the entire surgery so that the birthing process will not be visible to the mother, and the baby will be taken to the warmer to be evaluated and cleaned after birth but is available to be laid on the mother's chest at any point upon request.
|
|---|---|---|
|
Timing of Initiation of Family Bond Following Delivery
|
5.1 minutes
Standard Deviation 17.2
|
16.3 minutes
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: Assessed at time of discharge from the hospital (typically 3-5 days post-delivery)The tertiary objective of this study is to determine if breastfeeding was more likely to occur between the family-centered cesarean delivery method and traditional cesarean delivery method.
Outcome measures
| Measure |
Method 1 (Family-Centered Cesarean)
n=68 Participants
Delivery through the Family-Centered Cesarean.
Family-Centered Cesarean: Procedure involves lowering part of the surgical drape exposing a transparent window through which the mother can watch the birth of her baby; the baby will be placed on her chest immediately after the delivery. Cleaning and evaluation of the baby will be done by a nurse who is standing at the head of the bed.
|
Method 2 (Traditional Cesarean)
n=61 Participants
Delivery through the Traditional Cesarean.
Traditional Cesarean: Procedure involves keeping the surgical drape up throughout the entire surgery so that the birthing process will not be visible to the mother, and the baby will be taken to the warmer to be evaluated and cleaned after birth but is available to be laid on the mother's chest at any point upon request.
|
|---|---|---|
|
Number (Percent) of Patients Planning to Breastfeeding After Discharge
|
47 Participants
|
33 Participants
|
Adverse Events
Method 1 (Family Centered Cesarean)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Method 2 (Traditional Cesarean)
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