Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women (DISSUC)
The Impact of Decidual Inclusion or Sparing in a Single Unlocked Closure of a Cesarean Uterine Incision: Randomized Controlled Trial
This study compares two ways of closing the uterus during cesarean delivery. In one group, the decidual layer near the uterine cavity is included in the suture. In the other group, this layer is left out. The study will examine whether these two methods differ in how well the uterine scar heals 6 to 9 months after surgery.
Women having an elective cesarean delivery will be randomly assigned to one of the two closure methods. Scar healing will be assessed by ultrasound after delivery. The goal is to determine whether one method is associated with better cesarean scar healing and fewer scar defects.
Studieoversikt
Status
Detaljert beskrivelse
Cesarean scar defects, also referred to as niches or isthmoceles, are associated with gynecologic symptoms and adverse outcomes in subsequent pregnancies. The effect of uterine closure technique on scar healing remains uncertain, particularly with regard to whether the cavum-near decidual layer should be included in or excluded from the suture during cesarean closure.
This study is a prospective, randomized, controlled trial comparing two approaches to single-layer, non-locked uterine closure during elective cesarean delivery: decidual inclusion and decidual sparing. In both study groups, all operative steps are standardized except for the handling of the cavum-near decidual layer at the uterotomy margin.
Participants will be followed 6 to 9 months after cesarean delivery, including blinded ultrasound assessment of cesarean scar healing. The objective is to determine whether decidual inclusion or decidual sparing is associated with differences in postoperative uterine scar healing and cesarean scar defect formation.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Amr S. Hamza, Assoc. Prof.
- Telefonnummer: +41564863513
- E-post: amr.hamza@ksb.ch
Studer Kontakt Backup
- Navn: Leonhard Schaeffer, Prof.
- Telefonnummer: +41564863506
- E-post: leonhard.schaeffer@ksb.ch
Studiesteder
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Canton of Aargau
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Baden, Canton of Aargau, Sveits, 5400
- Rekruttering
- Kantonsspital Baden
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Ta kontakt med:
- Amr S. Hamza, Assoc. Prof.
- Telefonnummer: +41564863513
- E-post: amr.hamza@ksb.ch
-
Ta kontakt med:
- Leonhard Schaeffer, Prof.
- Telefonnummer: +41564863506
- E-post: leonhard.schaeffer@ksb.ch
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Singleton, term pregnancy
- Elective cesarean section before labor onset or membrane rupture
- Maternal age >18 years
- Ability to provide informed consent
Exclusion Criteria:
- Placenta previa
- Maternal substance abuse or infection
- Suspected placenta accreta
- Diabetes
- one or more prior cesarean section
- Vulnerable participants (e.g., mental health conditions)
- Emergency cesarean sections
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Decidual Inclusion Closure
Participants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is included in the suture.
All other operative steps will be performed according to the standardized study protocol.
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During the cesarean section, the uterine incision is closed with a single-layered, non-locked suture. In this technique, the decidua (the uterine lining) is included in the closure. This means that the endometrial cells are part of the suture, potentially influencing the healing process of the uterine scar. Goal: The idea is that including the decidua may promote better healing and scar formation, reducing the risk of complications such as isthmocele and improving long-term uterine health. |
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Eksperimentell: Decidual Sparing Closure
Participants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is excluded from the suture.
All other operative steps will be performed according to the standardized study protocol.
|
Procedure: In this technique, the uterine incision is also closed using a single-layered non-locked suture, but the decidua is excluded from the closure. The suture is placed only through the myometrium (muscle layer) of the uterus, leaving the decidua out of the scar tissue. Goal: The intent is to observe if sparing the decidua results in better scar healing and a lower risk of isthmocele formation, as well as fewer long-term complications. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of participants with a cesarean scar niche measured by ultrasound
Tidsramme: 6 to 9 months post-operation
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Presence of a cesarean scar niche, defined as a myometrial indentation at the cesarean scar site with a depth of at least 2 mm, assessed by postoperative ultrasound.
The outcome will be reported as the proportion of participants with a niche in each treatment group.
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6 to 9 months post-operation
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Residual-to-adjacent myometrial thickness ratio
Tidsramme: 6 to 9 months post-operation
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Ratio of residual myometrial thickness to adjacent myometrial thickness measured by ultrasound.
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6 to 9 months post-operation
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Operative time
Tidsramme: Periprocedural
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Operative time in minutes
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Periprocedural
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Need for additional sutures for hemostasis
Tidsramme: Periprocedural
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Need for additional hemostatic sutures, yes (how many: __ Number) /no
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Periprocedural
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Length of hospital stay
Tidsramme: Postoperative day 2
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Length of postoperative hospital stay in days
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Postoperative day 2
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Postoperative pain intensity on the 11-point Numeric Rating Scale
Tidsramme: Postoperative day 2
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Pain intensity assessed using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain.
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Postoperative day 2
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Postoperative bleeding
Tidsramme: Postoperative day 2
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Clinically relevant postoperative bleeding, yes/no
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Postoperative day 2
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Wound infection
Tidsramme: Postoperative day 2
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Postoperative wound infection, yes/no
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Postoperative day 2
|
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Postoperative fever
Tidsramme: Postoperative day 2
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Postoperative fever, yes/no
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Postoperative day 2
|
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Abnormal uterine bleeding
Tidsramme: 6 to 9 months post-operation
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Abnormal uterine bleeding reported at follow-up, yes/no
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6 to 9 months post-operation
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Dysmenorrhea
Tidsramme: 6 to 9 months post-operation
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Dysmenorrhea reported at follow-up, yes/no
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6 to 9 months post-operation
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Chronic pelvic pain
Tidsramme: 6 to 9 months post-operation
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Chronic pelvic pain reported at follow-up, yes/no
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6 to 9 months post-operation
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Dyspareunia
Tidsramme: 6 to 9 months post-operation
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Dyspareunia reported at follow-up, yes/no
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6 to 9 months post-operation
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Cesarean scar niche length measured by ultrasound in mm
Tidsramme: 6 to 9 months post-operation
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Length of cesarean scar niche in mm measured by ultrasound.
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6 to 9 months post-operation
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Cesarean scar niche depth measured by ultrasound in mm
Tidsramme: 6 to 9 months post-operation
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Depth of cesarean scar niche in mm measured by ultrasound.
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6 to 9 months post-operation
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Cesarean scar niche width measured by ultrasound in mm
Tidsramme: 6 to 9 months post-operation
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Width of cesarean scar niche in mm measured by ultrasound.
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6 to 9 months post-operation
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Residual myometrial thickness measured by ultrasound in mm
Tidsramme: 6 to 9 months post-operation
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Residual myometrial thickness measured by ultrasound in mm
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6 to 9 months post-operation
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Presence of intrauterine fluid on ultrasound
Tidsramme: 6 to 9 months post-operation
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Presence or absence of intrauterine fluid on ultrasound.
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6 to 9 months post-operation
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Amr S. Hamza, Assoc. Prof., Kantonsspital Baden
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Psykiske lidelser
- Kjønnssykdommer, mannlige
- Mannlige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kjønnssykdommer, kvinner
- Seksuell dysfunksjon, fysiologisk
- Seksuelle dysfunksjoner, psykologiske
- Dyspareuni
Andre studie-ID-numre
- StudyKSBHAM001
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