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Outcomes Following Pre-marking of Episiotomy Location
Short and Long Term Outcomes of Patients With and Without Pre-marked Episiotomy Location
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Purpose: To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.
Hypothesis: Women following episiotomy following pre-marking of the location will suffer from fewer short- and long-term complications compared to those without pre-marked episiotomy location.
Study type: prospective randomized-controlled trial
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Sharon Davidesko, MD
- Telefoonnummer: +972546837362
- E-mail: shazadmoni85@gmail.com
Studie Locaties
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-
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Be'er Sheva, Israël, 84101
- Werving
- Soroka University Medical Center
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Contact:
- Sharon Davidesko, MD
- Telefoonnummer: +972546837362
- E-mail: shazadmoni85@gmail.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- women 18 years of age or older who present in active labour to our center and consent to participate in the study
Exclusion Criteria:
- women under 18 years of age or those who do not or are unable to provide informed consent to participate in the study
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Pre-marked episiotomy location
Women in this group will undergo pre-marking of episiotomy location
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A template marking the pre-determined correct location of episiotomy will be used to mark to women in the interventional group
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Geen tussenkomst: No pre-marked episiotomy location
Women in this group will not undergo pre-marking of episiotomy location
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Extended laceration of the episiotomy
Tijdsspanne: Up to 1 hour following the episiotomy
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Additional perineal tears originating from the original episiotomy, as described in the birth chart
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Up to 1 hour following the episiotomy
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Third- and fourth-degree perineal tears
Tijdsspanne: Up to 2 hours following the episiotomy
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Perineal tears involving the anal sphincter in addition to the episiotomy, as documented in hospital records
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Up to 2 hours following the episiotomy
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Post-partum hemorrhage
Tijdsspanne: Up to 6 weeks following delivery
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Early (<24 hours) or later (24 hours to 6 weeks) hemorrhage following delivery requiring physician intervention as documented in medical records
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Up to 6 weeks following delivery
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Blood transfusion requirement
Tijdsspanne: Up to 5 days following delivery
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Any requirement for blood products following delivery as documented in the hospital discharge
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Up to 5 days following delivery
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Episiotomy site infection
Tijdsspanne: Up to 6 weeks following delivery
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any documented infection of the episiotomy site treated in ambulatory or hospital setting, as recorded in medical records
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Up to 6 weeks following delivery
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Requirement of resuturing of episiotomy or evacuation of hematoma
Tijdsspanne: up to 6 weeks following delivery
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Any additional surgical intervention required relating to the episiotomy, as recorded in medical records
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up to 6 weeks following delivery
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Long-term symptoms related to episiotomy
Tijdsspanne: Up to 5 years following delivery
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Any symptoms including perineal pain, dyspareunia, urine incontinence or fecal incontinence as reported by women using a numerical scale or dichotomic scale where appropriate
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Up to 5 years following delivery
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Perineal tears in subsequent deliveries
Tijdsspanne: Up to 5 years following delivery
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As recorded in hospital records
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Up to 5 years following delivery
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Surgical correction of episiotomy
Tijdsspanne: Up to 5 years following delivery
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Any additional surgical procedures required for correction of episiotomy related symptoms as recorded in medical records
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Up to 5 years following delivery
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Sharon Davidesko, MD, Soroka University Medical Center
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SOR-0089-20-CTIL
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
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