Blood Loss in UterotomyNCT07199621
Comparing Bet Scissors &Scalpel in Uterotomy in CS
An observational study of Blood Loss in Uterotomy, run by Assiut University.
Trial summary
To compare between rate of blood loss in uterine incision using scissors and scalpel in caesarean section Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Blood Loss in Uterotomy
- What is being tested?
- uterine incision by scissors versus scalpel
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Study population: pregnant women age 18-40 years ,their gestational age between 37-42 weeks admitted for Elective CS
Who may be able to join
- 1.pregnant women age 18-40 years 2.Gestational age between 37-42 weeks 3.Admitted for Elective caesarean delivery in the hospital
Who cannot join
- 1.placental pervia and accreta 2.cases refused to be recruited in the study 3. obstructed labor
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing Scissors Versus Scalpel in Uterine Incision During Cesarean Section
To compare between rate of blood loss in uterine incision using scissors and scalpel in caesarean section
Read the 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)
- Conditions
- Blood Loss in Uterotomy
- Being tested
- uterine incision by scissors versus scalpel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterine incision by scissors versus scalpelProcedure or surgery
procedure in uterotomy in cs
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing between Maternal blood loss in uterotomy using by scissors and scalpel
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Blood Loss in UterotomyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayra Hussien Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199621
- Sponsor's protocol ID
- uterotomy by scissor & scalpel
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35598118Smith 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.
PubMed 9277641Lee 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.
PubMed 18989137Gregory 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.
PubMed 21833896Antoine 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.
PubMed 32887190
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Scissors Versus Scalpel in Uterine Incision During Cesarean Section
- ClinicalTrials.gov ID
- NCT07199621
- Acronym / sponsor ID
- uterotomy by scissor & scalpel
- Conditions
- Blood Loss in Uterotomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- pregnant women age 18-40 years ,their gestational age between 37-42 weeks admitted for Elective CS
Key inclusion criteria (1 listed)
- 1.pregnant women age 18-40 years 2.Gestational age between 37-42 weeks 3.Admitted for Elective caesarean delivery in the hospital
Key exclusion criteria (1 listed)
- 1.placental pervia and accreta 2.cases refused to be recruited in the study 3. obstructed labor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uterine incision by scissors versus scalpelprocedure in uterotomy in cs | Procedure or surgery | – |
Primary outcome
Comparing between Maternal blood loss in uterotomy using by scissors and scalpel
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Background: PubMed 35598118Har-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.
- Background: PubMed 9277641Smith 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.
- Background: PubMed 18989137Lee 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.
- Background: PubMed 21833896Gregory 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.
- Background: PubMed 32887190Antoine 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Loss in Uterotomy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nayra Hussien Ahmed (+201090639897, Drnayra0603@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing between Maternal blood loss in uterotomy using by scissors and scalpel (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07199621, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.