Clinical trial NCT02690077: Family-Centered Cesarean Delivery
Official title: Family-Centered Cesarean: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Earlier Family Bond Initiation
Maternal and Neonatal Outcomes
Keywords: Patient Satisfaction
Earlier Family Bond Initiation
Maternal and Neonatal Outcomes
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women ≥18 years of age
* Women with planned cesarean section
* ≥38 weeks of gestation
* Singleton fetus
* Reassuring fetal status (status of scheduled, green and some yellow

Exclusion Criteria:

* Women with an urgent or emergency clinical situation in which the medical staff caring for the patient determines that obtaining consent would interfere with the patient's clinical care
* Patients that decline to consent to participate (an opt out log including the consenters initials, time of day, and reason is kept)
* Patients with anticipated heavy intraoperative bleeding (bleeding disorders, placenta previa, suspected placenta abruption, etc.)
* Known maternal co-morbidities that could impact neonatal well-being (e.g., uncontrolled diabetes, etc.)
* Chorioamnionitis or prolonged rupture of membranes (≥18 hours in duration)
* Known fetal anomalies
* BMI ≥45 kg/m2
* Estimated fetal weight \<2000 grams

Primary outcomes:
measure: 11-item Patient Satisfaction Questionnaire
timeFrame: Assessed at time of discharge from the hospital (typically 3-5 days post-delivery)
Secondary outcomes:
measure: Timing of Initiation of Family Bond Following Delivery
timeFrame: Assessed in Operating Room
measure: Number (Percent) of Patients Planning to Breastfeeding After Discharge
timeFrame: Assessed at time of discharge from the hospital (typically 3-5 days post-delivery)
Other outcomes:
Locations:
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Sinai Medical Center
state: Wisconsin
Study officials:
affiliation: Aurora Health Care, Inc.
name: Marie M Forgie, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.