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ERAS Protocol on Maternal and Fetal Outcomes Following Elective Cesarean Section

NCT06753058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2024-12-31

No results posted yet for this study

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

Interventions

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.

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.

BEHAVIORAL

Mother baby bonding

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.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06753058 on ClinicalTrials.gov