Patient SatisfactionFCCNCT02690077

Family-Centered Cesarean Delivery

A study testing Family-Centered Cesarean and Traditional Cesarean in people with Patient Satisfaction and Earlier Family Bond Initiation, run by Wake Forest University Health Sciences at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Patient Satisfaction, Earlier Family Bond Initiation, Maternal and Neonatal Outcomes
What is being tested?: Family-Centered Cesarean and Traditional Cesarean
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 149 participants
Where: 2 sitesUnited States
Study dates: 1 Jun 2016to 29 Oct 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233

Other trials in United States

About this study

Official title: Family-Centered Cesarean: A Randomized Controlled Trial

Read the 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.

Conditions: Patient Satisfaction, Earlier Family Bond Initiation, Maternal and Neonatal Outcomes
Being tested: Family-Centered Cesarean, Traditional Cesarean
Keywords: Patient Satisfaction, Earlier Family Bond Initiation, Maternal and Neonatal Outcomes
Medical subject headings: Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Family-Centered CesareanProcedure or surgery
Also called Gentle 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.
Traditional CesareanProcedure or surgery
Also called Cesarean Section
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.

Study groups in NCT02690077
Study group	Role	What they receive
Method 1 by Preference 1	Active comparator	Delivery through the Family-Centered Cesarean for patients with known Family-Centered preference. Receives: Procedure: Family-Centered Cesarean
Method 1 by Preference 2	Active comparator	Delivery through the Family-Centered Cesarean for patients with known Traditional Cesarean preference. Receives: Procedure: Family-Centered Cesarean
Method 2 by Preference 1	Active comparator	Delivery through the Traditional Cesarean for patients with known Family-Centered preference. Receives: Procedure: Traditional Cesarean
Method 2 by Preference 2	Active comparator	Delivery through the Traditional Cesarean for patients with known Traditional Cesarean preference. Receives: Procedure: Traditional Cesarean

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
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.
Measured: Assessed in Operating Room
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.
Measured: Assessed at time of discharge from the hospital (typically 3-5 days post-delivery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201629 Oct 2021

First posted24 Feb 2016 (estimated)
Study start1 Jun 2016
Primary completion1 Aug 2018
Study completion29 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Patient SatisfactionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02690077
Sponsor's protocol ID: 02-16
Acronym: FCC
Status last verified: Apr 2024
First submitted: 12 Feb 2016
Last updated: 3 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 25572878
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.
PubMed 18651885
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.
PubMed 25201938
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.
PubMed 24847031
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.
PubMed 25145718
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.
PubMed 34454161

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Family-Centered Cesarean: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02690077
Acronym / sponsor ID: FCC / 02-16
Conditions: Patient Satisfaction, Earlier Family Bond Initiation, Maternal and Neonatal Outcomes
Keywords: Patient Satisfaction, Earlier Family Bond Initiation, Maternal and Neonatal Outcomes
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: 1 Jun 2016 (actual)
Primary completion: 1 Aug 2018 (actual)
Study completion: 29 Oct 2021 (actual)
First posted: 24 Feb 2016 (estimated)
Results: Posted 31 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Method 1 by Preference 1	Active comparator	Procedure: Family-Centered CesareanDelivery through the Family-Centered Cesarean for patients with known Family-Centered preference.
Method 1 by Preference 2	Active comparator	Procedure: Family-Centered CesareanDelivery through the Family-Centered Cesarean for patients with known Traditional Cesarean preference.
Method 2 by Preference 1	Active comparator	Procedure: Traditional CesareanDelivery through the Traditional Cesarean for patients with known Family-Centered preference.
Method 2 by Preference 2	Active comparator	Procedure: Traditional CesareanDelivery through the Traditional Cesarean for patients with known Traditional Cesarean preference.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Family-Centered CesareanAlso: Gentle CesareanProcedure 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.	Procedure or surgery	Method 1 by Preference 1, Method 1 by Preference 2
Traditional CesareanAlso: Cesarean SectionProcedure 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.	Procedure or surgery	Method 2 by Preference 1, Method 2 by Preference 2

Primary outcome

11-item Patient Satisfaction Questionnaire
Time frame: 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).

2 secondary outcomes

Timing of Initiation of Family Bond Following Delivery
Time frame: Assessed in Operating Room
Number (Percent) of Patients Planning to Breastfeeding After Discharge
Time frame: Assessed at time of discharge from the hospital (typically 3-5 days post-delivery)

Results and safety

Results posted to the registry on 31 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Method 1 (Family-Centered Cesarean)	73	68
Method 2 (Traditional Cesarean)	76	61

Primary outcome: 11-item Patient Satisfaction Questionnaire

Time frame: Assessed at time of discharge from the hospital (typically 3-5 days post-delivery). Mean (Standard Deviation). Unit: units on a scale

Measure	Method 1 (Family-Centered Cesarean) n = 68	Method 2 (Traditional Cesarean) n = 61
How satisfied were you with your involvement with the delivery of the baby?	4.6 (0.8)	4.4 (0.9)
Did the method for delivery meet your expectations?	4.6 (0.7)	4.3 (1.0)
Based on previous cesarean delivery how satisfied are you with the method of delivery of your baby?	4.9 (0.7)	4.7 (1.0)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years, 1 month (participants were followed through discharge).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Method 1 (Family Centered Cesarean)	0 of 73 (0%)	0 of 73 (0%)	0 of 73
Method 2 (Traditional Cesarean)	0 of 76 (0%)	0 of 76 (0%)	0 of 76

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25572878Armbrust 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.
Background: PubMed 18651885Smith 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.
Background: PubMed 25201938Magee 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.
Background: PubMed 24847031de 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.
Background: PubMed 25145718Moran-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.
Results publication: PubMed 34454161Kram 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marie M Forgie, DO principal investigator

Aurora Health Care, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

11-item Patient Satisfaction Questionnaire (time frame: Assessed at time of discharge from the hospital (typically 3-5 days post-delivery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02690077, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.