NCT02690077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2021

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 31, 2023

Completed
Last Updated

October 3, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

February 12, 2016

Results QC Date

February 2, 2022

Last Update Submit

October 1, 2024

Conditions

Patient SatisfactionEarlier Family Bond InitiationMaternal and Neonatal Outcomes

Keywords

Patient SatisfactionEarlier Family Bond InitiationMaternal and Neonatal Outcomes

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • Timing of Initiation of Family Bond Following Delivery

    Assessed in Operating Room

  • Number (Percent) of Patients Planning to Breastfeeding After Discharge

    Assessed at time of discharge from the hospital (typically 3-5 days post-delivery)

Study Arms (4)

Method 1 by Preference 1

ACTIVE COMPARATOR

Delivery through the Family-Centered Cesarean for patients with known Family-Centered preference.

Procedure: Family-Centered Cesarean

Method 1 by Preference 2

ACTIVE COMPARATOR

Delivery through the Family-Centered Cesarean for patients with known Traditional Cesarean preference.

Procedure: Family-Centered Cesarean

Method 2 by Preference 1

ACTIVE COMPARATOR

Delivery through the Traditional Cesarean for patients with known Family-Centered preference.

Procedure: Traditional Cesarean

Method 2 by Preference 2

ACTIVE COMPARATOR

Delivery through the Traditional Cesarean for patients with known Traditional Cesarean preference.

Procedure: Traditional Cesarean

Interventions

Family-Centered CesareanPROCEDURE

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.

Also known as: Gentle Cesarean
Method 1 by Preference 1Method 1 by Preference 2
Traditional CesareanPROCEDURE

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.

Also known as: Cesarean Section
Method 2 by Preference 1Method 2 by Preference 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (6)

  • 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.

    PMID: 25572878BACKGROUND

  • 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.

    PMID: 18651885BACKGROUND

  • 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.

    PMID: 25201938BACKGROUND

  • 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.

    PMID: 24847031BACKGROUND

  • 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.

    PMID: 25145718BACKGROUND

  • 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.

    PMID: 34454161RESULT

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Jessica J F Kram, MPH
Organization
Advocate Aurora Health
jessica.kram@aah.org
414-219-5594

Study Officials

  • Marie M Forgie, DO

    Aurora Health Care, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2016

First Posted

February 24, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2018

Study Completion

October 29, 2021

Last Updated

October 3, 2024

Results First Posted

March 31, 2023

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)