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The Aim of Our Study Was to Evaluate the Outcomes in Women Who Implemented the Enhanced Recovery After Surgery Protocol at Delivery by Cesarean DeliveryERASNCT05841888

Implementation of Enhanced Recovery in Women Undergoing Cesarean Delivery

An observational study of The Aim of Our Study Was to Evaluate the Outcomes in Women Who Implemented the Enhanced Recovery After Surgery Protocol at Delivery by Cesarean Delivery, run by Ali Yavuzcan at 1 site in Turkey (Türkiye).

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

Aim: The aim of our study was to evaluate the outcomes in women who implemented the ERAS (Enhanced Recovery after Surgery) protocol at delivery by cesarean delivery(CD). Methods: The women who underwent CD with ERAS or standard perioperative care (SC) were randomized. Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
How many people
180 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 Nov 2020to 1 Mar 2021
How long will I take part?
30 Days
Phase
Observational
Are there results?
None posted in the registry

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 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Pregnant women aged ≥18 years and ≥37 weeks of gestational age who were admitted to our hospital.

Who may be able to join

  • Pregnant women
  • aged ≥18 years
  • ≥37 weeks of gestational age
  • admitted to our hospital.

Who cannot join

  • Pregnant women who underwent CD with an indication for emergency cesarean (pregnancy complications such
  • preeclampsia,
  • placenta previa,
  • detached placenta,
  • fetal distress, infection,
  • disease causing systemic morbidity,
Show all 10Show fewer
  • intestinal adhesions secondary to previous operations) .
  • pregnant women with any substance addiction
  • those who did not give informed consent were excluded from the study.
  • Women who did not comply with the study protocols during were not included.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ali Yavuzcan

    Düzce, 81620

Other trials in Turkey (Türkiye)

About this study

Official title: Implementation of Enhanced Recovery in Women Undergoing Cesarean Delivery Improve Breastfeeding and Maternal Perioperative Outcomes

Aim: The aim of our study was to evaluate the outcomes in women who implemented the ERAS (Enhanced Recovery after Surgery) protocol at delivery by cesarean delivery(CD).

Methods: The women who underwent CD with ERAS or standard perioperative care (SC) were randomized. In terms of the time to first flatus (TFF), visual pain score (VAS), successful breastfeeding, time of initiation of breastfeeding, time to returning to daily activities, hemoglobin values, postoperative nausea and vomiting, readmission to the hospital, postoperative wound infection, postpartum blues (PB) and the need for blood transfusion were compared between two groups.

Read the detailed description

Our study was conducted as a prospective study in the Obstetric and Gynecology Department of the Düzce University Faculty of Medicine. The study was initiated after the Düzce University Ethics Committee approval(no: KAEK/2020/239). The study followed the principles set out in the Declaration of Helsinki. Pregnant women aged ≥18 years and ≥37 weeks of gestational age who were admitted to our hospital between November 2020 and February 2021 were included in the study. Pregnant women who underwent CD with an indication for emergency cesarean (pregnancy complications such as preeclampsia, placenta previa, detached placenta, fetal distress, infection, disease causing systemic morbidity, or intestinal adhesions secondary to previous operations) were excluded. In addition, pregnant women with any substance addiction and those who did not give informed consent were excluded from the study. Women who did not comply with the study protocols during were not included. Informed consent was obtained from all pregnant women before starting the study. Women who accepted to participate in the study and met the criteria were given the ERAS and control group protocol cards without being shown, upside down, and patients who would or would not receive the ERAS protocol were randomized accordingly. Age, body mass index (BMI), gravidy, parity, gestational age, indication, hemogram value, anesthesia method, presence of comorbidities, and contact information were recorded.

Women who underwent CD and received standard perioperative care (SC) constituted the control group.15 Patients in the SC group who were hospitalized for CD were discontinued from oral water intake and nutrition preoperatively at 00:00 the night before CD. Pethidine hydrochloride was administered as an opioid in addition to postoperative oral paracetamol and parenteral diclofenac sodium after surgery. The bladder catheter was withdrawn at the 6 th postoperative hour, and out-of-bed mobilization was started then. Oral feeding was started after first flatus. Dressings were applied in the morning on the 1st and 2nd postoperative day.

Pregnant women to whom the ERAS protocol would be implemented were given detailed information by explaining the preoperative, intraoperative, and postoperative ERAS elements. They signed the informed consent forms. The study group was formed with patients who received the ERAS protocol. The ERAS Practice Guideline in CD for the pre-operative, intra-operative and post-operative care were implamented.16-18 The women in ERAS group was not be encouraged to drink clear liquids until 2 hour (h) before surgery, to eat a light meal 6 h before surgery or to receive oral carbohydrate supplementation 2 h before CD since the anesthesia department of our hospital did not approve. We could not given antacids and histamine H2 receptor as premedication to women in ERAS group. All of the subjects implemented or not in both ERAS and SC groups were summarized in Table 1. Perioperative information and implementation of ERAS protocol items were checked and recorded in the ERAS protocol checklist. After discharge, patients were called from the contact addresses they provided to check their status and get information and were called to the outpatient clinic within 2 weeks after discharge.

Postoperative pain was calculated with the visual pain score (Visual Analog Scale, VAS) in all patients included in our study. All patients in SC group and in the ERAS protocol group were asked to place a line between 0 and 10 on a horizontal line describing their pain status. The mildest pain represented as 0 and 10 represented the most severe pain.19 The time of first flatulence (TFF)20 and the time of first breastfeeding were recorded as hours. Women were asked when they were able to do things such as eating, walking, and taking care of their baby without assistance and feeling comfortable. The time to return to daily activities is indicated in days. Patients who re-admitted to the hospital within 30 days were considered as readmission.20 The preoperative Hb and the postoperative Hb level (ΔHb) were calculated as gr/dl. It has been accepted that successful breastfeeding is achieved in newborns who are given only breast milk in the appropriate position without formula or additional food.21 The Coronavirus disease (COVID-19) pandemic has been shown to induce a desire for early discharge in all patients after CD.22-23 In our study, an objective evaluation of length of hospital stay could not be made since the discharge times of the patients were affected by COVID-19 pandemic.

The study results were reported in accordance with the CONSORT guideline.

Keywords
Breastfeeding initation time, cesarean delivery, enhanced recovery after surgery, pain, perioperative outcomes
Medical subject headings
Pain

What participants receive

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

Study groups in NCT05841888
Study groupRoleWhat they receive
Group 1standard perioperative care (SC)
Group 2Enhanced Recovery after Surgery (ERAS)

What is being measured

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

  1. postoperative pain

    Visual Analogue Scale

    Measured: 30 day

  2. Time to first flatus

    hour

    Measured: 30 day

  3. time to returning to daily activities

    day

    Measured: 30 day

  4. ΔHb

    gr/dl

    Measured: 30 day

Secondary outcomes (2)
  1. the breastfeeding initiation time

    hour

    Measured: 30 day

  2. Successful breastfeeding

    newborns who are given only breast milk in the appropriate position without formula or additional food

    Measured: 30 day

Timeline

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

  1. First posted3 May 2023
  2. Study start17 Nov 2020
  3. Primary completion17 Feb 2021
  4. Study completion1 Mar 2021

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
180 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT05841888
Sponsor's protocol ID
Ayavuzcan
Acronym
ERAS
Status last verified
Apr 2023
First submitted
4 Apr 2023
Last updated
3 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of The Aim of Our Study Was to Evaluate the Outcomes in Women Who Implemented the Enhanced Recovery After Surgery Protocol at Delivery by Cesarean Delivery, run by Ali Yavuzcan at 1 site in Turkey (Türkiye).

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 4 inclusion and 10 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 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

postoperative pain (time frame: 30 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 May 2023.

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