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Not yet recruiting NCT07199621

Comparing Bet Scissors &Scalpel in Uterotomy in CS

Observational Blood Loss in Uterotomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: uterine incision by scissors versus scalpel.
Who it may be relevant to
Registry conditions: Blood Loss in Uterotomy. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparing Scissors Versus Scalpel in Uterine Incision During Cesarean Section

Overview

To compare between rate of blood loss in uterine incision using scissors and scalpel in caesarean section

Detailed description

In present-day obstetrics, cesarean delivery occurs in one in three women in the United States, and in up to four of five women in some regions of the world . . Concurrently, despite attempts to encourage vaginal birth after previous cesareans, the cesarean delivery rate increased steadily from 5 to 30-32% over the last 10 years, with a parallel increase in costs as well as short- and long-term maternal, neonatal and childhood complications( 1). Approximately 30% of women will experience a maternal or neonatal complication during childbirth. Both cesarean and vaginal delivery is associated with well-known measurable short- and long-term maternal and neonatal complications and benefits.(2 ) the most concerning complications from cesareans are the neonatal respiratory morbidity and the impact on a mother's future reproductive health, including the risk of abnormal placentation such as placenta previa or accreta.( 3) Fetal laceration injury at cesarean delivery is not rare, especially when it is performed for nonvertex presentation. The minority of obstetric records show documentation of such lacerations, suggesting that this complication often may not be recognized by obstetricians 4. During urgent CS, the surgeon should bear in mind that the presence of PROM or meconium-stained amniotic fluid should prompt extra care and application of preventive measures to decrease blood loss .(.4) To the best of our knowledge, no studies have investigated the association of type of uterotomy and incidence of accidental fetal lacerations. For this reason, in this study we evaluated whether using scissors instead of scalpel in uterotomy can prevent maternal blood loss at time of CS (.5)

Interventions

  • Procedure uterine incision by scissors versus scalpel
    procedure in uterotomy in cs

Primary outcome measures

  • Comparing between Maternal blood loss in uterotomy using by scissors and scalpel [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • 1.pregnant women age 18-40 years 2.Gestational age between 37-42 weeks 3.Admitted for Elective caesarean delivery in the hospital

Exclusion criteria

  • 1.placental pervia and accreta 2.cases refused to be recruited in the study 3. obstructed labor

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Har-Shai L, Kreichman R, Kedar R, Osovsky M, Chen R, Lavi I, Metanes I, Segal M, Ofek SE, Mattar S, Hassan S, Kramer A, Bryzgalin L, Ad-El D, Sagi-Dain L, Lavie O, Har-Shai Y. Risk factors associated with accidental fetal skin lacerations during cesarean delivery. Int J Gynaecol Obstet. 2023 Jan;160(1):131-135. doi: 10.1002/ijgo.14273. Epub 2022 Jun 2. PMID 35598118
  • Smith JF, Hernandez C, Wax JR. Fetal laceration injury at cesarean delivery. Obstet Gynecol. 1997 Sep;90(3):344-6. doi: 10.1016/s0029-7844(97)00284-6. PMID 9277641
  • Lee YM, D'Alton ME. Cesarean delivery on maternal request: maternal and neonatal complications. Curr Opin Obstet Gynecol. 2008 Dec;20(6):597-601. doi: 10.1097/GCO.0b013e328317a293. PMID 18989137
  • Gregory KD, Jackson S, Korst L, Fridman M. Cesarean versus vaginal delivery: whose risks? Whose benefits? Am J Perinatol. 2012 Jan;29(1):7-18. doi: 10.1055/s-0031-1285829. Epub 2011 Aug 10. PMID 21833896
  • Antoine C, Young BK. Cesarean section one hundred years 1920-2020: the Good, the Bad and the Ugly. J Perinat Med. 2020 Sep 4;49(1):5-16. doi: 10.1515/jpm-2020-0305. PMID 32887190

Identifiers

NCT: NCT07199621 · uterotomy by scissor & scalpel

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗