ERAS Protocol on Maternal and Fetal Outcomes Following Elective Cesarean Section

NCT06753058 | Completed

• 1 other identifier: Decision no: 502/31.05.2021
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to investigate the maternal, fetal, and neonatal outcomes in parturients scheduled to undergo elective cesarean section (CS) receiving either standard care or enhanced recovery after surgery (ERAS) protocol. Primary purpose is to learn if implementing ERAS protocol can improve maternal outcomes in pregnant women aged greater than 18 years scheduled to undergo elective CS under spinal anesthesia using patient reported outcome mesaure (PROM). Secondary purpose is to learn if implementation of maternal ERAS protocol can improve neonatal outcome in terms of nutrition and breastfeeding. The main questions that aims to answer are maternal recovery outcome measure determined by obstetric quality recovery score (ObsQoR) which has been known as a patient reported outcome mesaure (PROM) and neonatal outcome assessed by pediatricians. Primary outcome measure is improved maternal recovery in term of ObsQoR in the ERAS pathway. Secondary outcome measure is improved neonatal outcome in terms of nutrition and breastfeeding in the ERAS pathway.

Conditions

Pregnant Women; Enhanced Recovery After Surgery (ERAS) Protocol

Keywords

enhanced reocery after surgery; obstetric quality -of-recovery score; cesarean section; spinal anesthesia; newborn well being

Outcome Measures

Primary Outcomes (1)

• improved maternal recovery in term of ObsQoR in the ERAS pathway

  Primary outcome measure is described as maternal recovery outcome measure determined by obstetric quality recovery score (ObsQoR) which has been known as a patient reported outcome mesaure (PROM) and neonatal outcome assessed by pediatricians. ObsQoR-11 scores with Likert scale corresponds to; zero being very poor and 110 being excellent

  From enrollment to the end of ERAS or control postpartum 24 hours

Secondary Outcomes (1)

• implementation of maternal ERAS protocol improves newborn nutrition and breastfeeding

  From enrollment to the end of ERAS or control postpartum 24 hours

Study Arms (2)

STANDARD CARE (CONTROL)

NO INTERVENTION

Standard care as control includes ROUTINE preoperative, peroperative and postoperative approach of the institution for the management of cesraean delivery under spinal anesthesia.

ERAS PATHWAY

EXPERIMENTAL

ERAS INTERVENTION includes 3 steps: 1. preoperative components (face to face education/information about fasting, Cesarean Section and/or anesthesia, antimicrobial prophylaxis, breastfeeding preparation and support, fasting schedule, anemia screening-hemoglobin optimization if needed), 2. peroperative components (antibiotic and antiemetic prophylaxis, management of neuraxial anesthesia, maintenance of normothermia, uterotonic use), 3. postoperative components (early oral intake/urinary catheter removal/mobilization, early mother-newborn bonding and encouraged breastfeeding).

Dietary Supplement: 25 gram of maltodextrin in 330 mL , Nutricia Fantomalt 4 Gram, Nutri Gıda Ürünleri San. ve Tic. A.Ş., Istanbul, Türkiye, 2 h prior to surgery.; Behavioral: Mother baby bonding

Interventions

25 gram of maltodextrin in 330 mL , Nutricia Fantomalt 4 Gram, Nutri Gıda Ürünleri San. ve Tic. A.Ş., Istanbul, Türkiye, 2 h prior to surgery. DIETARY_SUPPLEMENT

Although 45 g of different carbohydrate solutions either Gatorade 54 g carbohydrate or clear apple juice 56 g carbohydrate in non-diabetic women have been recommended by SOAP, we preferred 25 g of carbohydrate, fantomalt, nutricia, diluted in the 330 mL in both diabetic and non-diabetic pregnant women.

ERAS PATHWAY

Mother baby bonding BEHAVIORAL

In the ERAS implemented group, mother-baby contact to promote early bonding was established, and both mother and baby were encouraged for breastfeeding. In the control group, only mother-baby contact was facilitated without proactive breastfeeding encouragement.

ERAS PATHWAY

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: older than 18 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) II or III term pregnant women aged ≥18 years scheduled to undergo elective CS under spinal anesthesia between June 2021 and June 2023 in Gazi University

You may not qualify if:

• Parturients younger than \<18 years old with fetal compromise, ASA IV or V physical status and emergency cases, medical contraindication to regional anesthesia particularly spinal block

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University School of Medicine Department of Anesthesiology and Reanimation

Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (1)

• Ozdemir MG, Gunaydin B, Bayram M, Hirfanoglu IM. Effect of enhanced recovery after surgery (ERAS) protocol on maternal and fetal outcomes following elective cesarean section: an observational trial. BMC Pregnancy Childbirth. 2025 Apr 29;25(1):517. doi: 10.1186/s12884-025-07583-3.

  PMID: 40301800 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: In this interventional study, Enhanced Recovery After Surgery (ERAS) protocol for cesarean has been planned to apply to the parturients who accepted to participate to the study. Unfortunately randomization cannot be done since the strategy for assigning participants to apply ERAS intervention was based on the obstetric team's preference first. The rest of the parturients were regarded as the control group (standard care) who did not receive ERAS intervention.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 31, 2024
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD and supporting information will be available when our work is published for 10 years .

Locations

TU (1)