- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07651241
Maternal and Fetal Outcomes in Elective vs Emergency Cesarean Section
11. juni 2026 opdateret af: Abdelsalam Gomaa, Assiut University
Maternal and Fetal Outcomes in Elective and Emergency Cesarean Section in Women's Health Hospital
Cesarean section (CS) rates have increased substantially worldwide and in Egypt, where they now account for the majority of deliveries.
Maternal and neonatal outcomes may differ between elective and emergency CS.
Emergency cesarean sections are generally associated with higher maternal morbidity, including increased risks of postpartum hemorrhage, infection, blood transfusion, longer operative time, and prolonged hospital stay.
Neonatal outcomes following emergency CS may also be less favorable, with higher rates of low Apgar scores, respiratory distress, and NICU admission.
However, findings remain inconsistent across studies, highlighting the need for further prospective research to comprehensively compare maternal and fetal outcomes between elective and emergency cesarean deliveries.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
210
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Alwany Elsenousy Eldreemy Elkasse, professor
- Telefonnummer: +2001225005036
- E-mail: alwany.elsenousy@med.aun.edu.eg
Undersøgelse Kontakt Backup
- Navn: Mohamed Bahaa Mohamed Ahmed, lecturer
- Telefonnummer: +200 10 22422960
- E-mail: m.bahaa@med.aun.edu.eg
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Pregnant women undergoing cesarean section (elective or emergency) at Women's Health Hospital during the study period.
Eligible participants will include women with singleton pregnancies who meet the inclusion criteria and provide complete clinical data.
Maternal and neonatal outcomes will be assessed and compared between elective and emergency cesarean section groups.
Beskrivelse
Inclusion Criteria:
- 1- Pregnant women undergoing cesarean section 2- Singleton pregnancy 3- Gestational age ≥ 28 weeks 4- Age 18-45 years
Exclusion Criteria:
- 1- Multiple pregnancy 2- Known fetal anomalies 3- Intrauterine fetal demise before cesarean section 4- Severe maternal comorbidities (e.g., cardiac disease, renal failure) 5- Rupture uterus 6- patients with placenta previa or accreta spectrum
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
• Maternal morbidity composite outcome • Neonatal morbidity composite outcome
Tidsramme: From cesarean delivery until hospital discharge (up to 7 days postpartum).
|
From cesarean delivery until hospital discharge (up to 7 days postpartum).
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Length of stay
Tidsramme: From cesarean delivery until maternal hospital discharge (days), up to 7 days postpartum.
|
From cesarean delivery until maternal hospital discharge (days), up to 7 days postpartum.
|
|
Operative time
Tidsramme: Assessed during cesarean section, from skin incision to skin closure (minutes).
|
Assessed during cesarean section, from skin incision to skin closure (minutes).
|
|
Infection rate
Tidsramme: From cesarean delivery through 6 weeks postpartum.
|
From cesarean delivery through 6 weeks postpartum.
|
|
Effect of confounding factors on neonatal outcomes (gestational age at delivery, type of anaesthesia)
Tidsramme: Assessed at birth and during neonatal hospitalization, up to 28 days after birth.
|
Assessed at birth and during neonatal hospitalization, up to 28 days after birth.
|
|
Effect of confounding factors on maternal outcomes (BMI)
Tidsramme: BMI assessed at admission for delivery; association with maternal outcomes evaluated from cesarean delivery through hospital discharge (up to 7 days postpartum).
|
BMI assessed at admission for delivery; association with maternal outcomes evaluated from cesarean delivery through hospital discharge (up to 7 days postpartum).
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Betran AP, Torloni MR, Zhang JJ, Gulmezoglu AM; WHO Working Group on Caesarean Section. WHO Statement on Caesarean Section Rates. BJOG. 2016 Apr;123(5):667-70. doi: 10.1111/1471-0528.13526. Epub 2015 Jul 22. No abstract available.
- Lucas DN, Yentis SM, Kinsella SM, Holdcroft A, May AE, Wee M, Robinson PN. Urgency of caesarean section: a new classification. J R Soc Med. 2000 Jul;93(7):346-50. doi: 10.1177/014107680009300703.
- Boerma T, Ronsmans C, Melesse DY, Barros AJD, Barros FC, Juan L, Moller AB, Say L, Hosseinpoor AR, Yi M, de Lyra Rabello Neto D, Temmerman M. Global epidemiology of use of and disparities in caesarean sections. Lancet. 2018 Oct 13;392(10155):1341-1348. doi: 10.1016/S0140-6736(18)31928-7.
- Khasawneh W, Obeidat N, Yusef D, Alsulaiman JW. The impact of cesarean section on neonatal outcomes at a university-based tertiary hospital in Jordan. BMC Pregnancy Childbirth. 2020 Jun 1;20(1):335. doi: 10.1186/s12884-020-03027-2.
- Souza JP, Gulmezoglu A, Lumbiganon P, Laopaiboon M, Carroli G, Fawole B, Ruyan P; WHO Global Survey on Maternal and Perinatal Health Research Group. Caesarean section without medical indications is associated with an increased risk of adverse short-term maternal outcomes: the 2004-2008 WHO Global Survey on Maternal and Perinatal Health. BMC Med. 2010 Nov 10;8:71. doi: 10.1186/1741-7015-8-71.
- Sandall J, Tribe RM, Avery L, Mola G, Visser GH, Homer CS, Gibbons D, Kelly NM, Kennedy HP, Kidanto H, Taylor P, Temmerman M. Short-term and long-term effects of caesarean section on the health of women and children. Lancet. 2018 Oct 13;392(10155):1349-1357. doi: 10.1016/S0140-6736(18)31930-5.
- Doke PP, Vaidya VM, Narula APS, Patil AV, Panchanadikar TM, Wagh GN, Iyengar KS. Relative risk of postpartum maternal morbidity among cesarean-delivered women: A multisite prospective cohort study in a large district, India. J Family Med Prim Care. 2022 Dec;11(12):7705-7712. doi: 10.4103/jfmpc.jfmpc_1292_22. Epub 2023 Jan 17.
- Abdel-Aleem H, Shaaban OM, Hassanin AI, Ibraheem AA. Analysis of cesarean delivery at Assiut University Hospital using the Ten Group Classification System. Int J Gynaecol Obstet. 2013 Nov;123(2):119-23. doi: 10.1016/j.ijgo.2013.05.011. Epub 2013 Jul 31.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. juli 2027
Studieafslutning (Anslået)
1. september 2027
Datoer for studieregistrering
Først indsendt
11. juni 2026
Først indsendt, der opfyldte QC-kriterier
11. juni 2026
Først opslået (Faktiske)
16. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- MF_CS_2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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