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NCT06753058: ERAS
ERAS Protocol on Maternal and Fetal Outcomes Following Elective Cesarean Section
NA trial testing 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. in Pregnant Women in 450 participants. Completed in 1 June 2023.
1 June 2023
Quick facts
| Lead sponsor | Gazi University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 450 |
| Start date | 1 June 2021 |
| Primary completion | 1 June 2023 |
| Estimated completion | 1 June 2023 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- 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.
- Mother baby bonding
Conditions studied
- Pregnant Women — all drugs for Pregnant Women →
- Enhanced Recovery After Surgery (ERAS) Protocol — all drugs for Enhanced Recovery After Surgery (ERAS) Protocol →
Sponsor
Gazi University
Who can join
18 and older, female only, with Pregnant Women or Enhanced Recovery After Surgery (ERAS) Protocol. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effect of enhanced recovery after surgery (ERAS) protocol on maternal and fetal outcomes following elective cesarean section: an observational trial.
Özdemir MG, Gunaydin B, Bayram M, Hirfanoglu İM. · · 2025 · cited 1× · PMID 40301800 · DOI 10.1186/s12884-025-07583-3
Verify or expand the search:
- PubMed search for NCT06753058
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06753058 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gazi University
- Last refreshed: 31 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06753058.
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