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The purpose of this study is to determine if patient birthing experiences differ between the family-centered and traditional cesarean methods. We hypothesize that the family-centered cesarean method will lead to more unique and personalized cesarean birthing experiences without increasing the risks of adverse neonatal and maternal outcomes from those documented with the traditional cesarean.
Patients will be consented and randomized to one of two delivery methods by the research coordinator, resident physician, charge nurse or nurse on the day of their planned cesarean section. Several variables of interest will be collected via the electronic medical record and within the OR. Additionally, assessment of patient satisfaction will be conducted following delivery. Questions from an 11-item questionnaire will be asked of the patient by the study coordinator, resident physician, nurse or charge nurses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Method 1 by Preference 1 | Active Comparator | Delivery through the Family-Centered Cesarean for patients with known Family-Centered preference. |
|
| Method 1 by Preference 2 | Active Comparator | Delivery through the Family-Centered Cesarean for patients with known Traditional Cesarean preference. |
|
| Method 2 by Preference 1 | Active Comparator | Delivery through the Traditional Cesarean for patients with known Family-Centered preference. |
|
| Method 2 by Preference 2 | Active Comparator | Delivery through the Traditional Cesarean for patients with known Traditional Cesarean preference. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-Centered Cesarean | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 11-item Patient Satisfaction Questionnaire | 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). | Assessed at time of discharge from the hospital (typically 3-5 days post-delivery) |
| Measure | Description | Time Frame |
|---|---|---|
| Timing of Initiation of Family Bond Following Delivery | The 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. | Assessed in Operating Room |
| Number (Percent) of Patients Planning to Breastfeeding After Discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie M Forgie, DO | Aurora Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311 | United States | ||
| Aurora Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25572878 | Background | Armbrust R, Hinkson L, von Weizsacker K, Henrich W. The Charite cesarean birth: a family orientated approach of cesarean section. J Matern Fetal Neonatal Med. 2016;29(1):163-8. doi: 10.3109/14767058.2014.991917. Epub 2015 Jan 9. | |
| 18651885 | Background | Smith J, Plaat F, Fisk NM. The natural caesarean: a woman-centred technique. BJOG. 2008 Jul;115(8):1037-42; discussion 1042. doi: 10.1111/j.1471-0528.2008.01777.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 11-item Patient Satisfaction Questionnaire | 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). | Posted | Mean | Standard Deviation | units on a scale | Assessed at time of discharge from the hospital (typically 3-5 days post-delivery) |
|
2 years, 1 month (participants were followed through discharge).
No adverse events were noted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica J F Kram, MPH | Advocate Aurora Health | 414-219-5594 | jessica.kram@aah.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2019 | Jan 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D002585 | Cesarean Section |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
|
| Traditional Cesarean | Procedure | 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. |
|
|
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. |
| Assessed at time of discharge from the hospital (typically 3-5 days post-delivery) |
| Milwaukee |
| Wisconsin |
| 53233 |
| United States |
| 25201938 | Background | Magee SR, Battle C, Morton J, Nothnagle M. Promotion of family-centered birth with gentle cesarean delivery. J Am Board Fam Med. 2014 Sep-Oct;27(5):690-3. doi: 10.3122/jabfm.2014.05.140014. |
| 24847031 | Background | de Alba-Romero C, Camano-Gutierrez I, Lopez-Hernandez P, de Castro-Fernandez J, Barbero-Casado P, Salcedo-Vazquez ML, Sanchez-Lopez D, Cantero-Arribas P, Moral-Pumarega MT, Pallas-Alonso CR. Postcesarean Section Skin-to-Skin Contact of Mother and Child. J Hum Lact. 2014 Aug;30(3):283-286. doi: 10.1177/0890334414535506. Epub 2014 May 20. |
| 25145718 | Background | Moran-Peters JA, Zauderer CR, Goldman S, Baierlein J, Smith AE. A quality improvement project focused on women's perceptions of skin-to-skin contact after cesarean birth. Nurs Womens Health. 2014 Aug-Sep;18(4):294-303. doi: 10.1111/1751-486X.12135. |
| 34454161 | Result | Kram JJF, Montgomery MO, Moreno ACP, Romdenne TA, Forgie MM. Family-centered cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol MFM. 2021 Nov;3(6):100472. doi: 10.1016/j.ajogmf.2021.100472. Epub 2021 Aug 26. |
| Excluded by IRB |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 |
| 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. |
|
|
| Secondary | Timing of Initiation of Family Bond Following Delivery | The 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. | Posted | Mean | Standard Deviation | minutes | Assessed in Operating Room |
|
|
|
| Secondary | Number (Percent) of Patients Planning to Breastfeeding After Discharge | 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. | Posted | Count of Participants | Participants | Assessed at time of discharge from the hospital (typically 3-5 days post-delivery) |
|
|
|
| 0 |
| 73 |
| 0 |
| 73 |
| 0 |
| 73 |
| EG001 | 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. | 0 | 76 | 0 | 76 | 0 | 76 |
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