- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03224247
Vertical Splitting of Muscle Layer in Lower Segment Cesarean Sections to Avoid Uterine Vessels Injury
Comparison Between Vertical Splitting Versus Transverse Cutting of Muscle Layer in Lower Segment Cesarean Sections to Avoid Uterine Vessels Injury: a Randomized Controlled Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Cesarean section is one of the oldest surgical interventions in the history of medicine.Since the first documented cesarean delivery in 1020 AD, various modifications have been made in the technique. It was a surgery performed as a last resort, mostly peri- or post-portem.
Many variations in cesarean section technique have been studied.our study aim is to decrease blood loss during cesarean section through decreasing incidence of uterine vessels injury. The investigator supposed that applying Vertical pull on a small C-shaped incision in the lower uterine segment during cesarean section allows the tissues to split along their natural arrangement, decreasing the probability of extension of the wound into the uterine vessels, thus; decreasing blood loss; operative time and maternal recovery.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Cairo, Egypt, 11311
- Ahmed Abass
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Elective cesarean section
- No medical disorders during pregnancy ( Hypertension, DM , ..)
- No coagulation disorders either congenital nor acquired.
Exclusion Criteria:
- Urgent or emergency cesarean section.
- Multiple pregnancy.
- Presence of medical disorders during pregnancy ( Hypertension, DM , ..)
- Presence of coagulation disorders either congenital nor acquired.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Transverse splitting
transverse cutting and/or pulling of lower uterine segment during lower segment cesarean section.
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Transverse cutting and/or pulling.of
lower uterine segment during lower cesarean section extending the uterine incision laterally.
|
Aktiv komparator: Vertical splitting
vertical splitting,of lower uterine segment during lower segment cesarean section.
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vertical splitting of lower uterine segment during lower cesarean section making the direction of traction up and downward instead of being laterally and we suppose that this will allow the tissues to split along their natural arrangement, decreasing the probability of extension of the wound into the uterine vessels, thus; decreasing blood loss; operative time and maternal recovery.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Uterine vessels injury
Tidsramme: 1 minute after extraction of the baby and placenta
|
the surgeon performing the cesarean section will detect if injury of uterine vessels occurred or not while extending uterine incision.
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1 minute after extraction of the baby and placenta
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
uterine incision extension
Tidsramme: 2 minutes extraction of the baby and placenta
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the surgeon performing the cesarean section will detect if uterine incision extension occurred or not after extraction of the baby and the placenta.
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2 minutes extraction of the baby and placenta
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intra-operative blood loss
Tidsramme: before closure of the abdominal wall layer
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blood loss will be assessed by circulating nurse through counting soaked surgical towels and gauze and calculating estimated blood loss in vacation suction system.
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before closure of the abdominal wall layer
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postpartum hemorrhage
Tidsramme: first 24 hours after delivery
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will be defined by postpartum blood loss of 1000cc
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first 24 hours after delivery
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postoperative pain
Tidsramme: 2 hours after delivery
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pain scale from 0 to 10 to assess postoperative pain after delivery
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2 hours after delivery
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postoperative pain
Tidsramme: 6 hours after delivery
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pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery
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6 hours after delivery
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postoperative pain
Tidsramme: 12 hours after delivery
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pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery
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12 hours after delivery
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postoperative pain
Tidsramme: 24 hours after delivery
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pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery
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24 hours after delivery
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Waled Hitler, Prof, Ainshams University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Vertical splitting in CS
Legemiddel- og utstyrsinformasjon, studiedokumenter
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