Comparing Bet Scissors &Scalpel in Uterotomy in CS | NCT07199621

Studies
Comparing Bet Scissors &Scalpel in Uterotomy in CS

NCT07199621

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Sep 30, 2025Actual

Enrollment

140Estimated

Phase

Not provided

Conditions

Blood Loss in Uterotomy

Interventions

uterine incision by scissors versus scalpel

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2025Estimated

Primary Completion Date

Oct 2026Estimated

Completion Date

Nov 2026Estimated

First Submitted Date

Sep 22, 2025

First Submission Date that Met QC Criteria

Sep 22, 2025

First Posted Date

Sep 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2025

Last Update Posted Date

Sep 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
uterine incision by scissors versus scalpel	Procedure	procedure in uterotomy in cs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparing between Maternal blood loss in uterotomy using by scissors and scalpel		baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

pregnant women age 18-40 years ,their gestational age between 37-42 weeks admitted for Elective CS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nayra Hussien Ahmed	Contact	+201090639897		Drnayra0603@med.aun.edu.eg

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35598118	Background	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.
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