NCT03392077

Brief Summary

Cesarean delivery is one of the most commonly performed surgical operations worldwide Cesarean delivery even as an elective procedure has been associated with considerable maternal risks compared with vaginal delivery. Some of the complications include postpartum hemorrhage, uterine infection, urinary tract infection, wound infection, septicemia and maternal death. Over the years, many variations in the surgical technique of Cesarean delivery have been employed with the main purpose of improving its safety. A woman's cervix is firm and undilated at the beginning of pregnancy, but progressive remodeling occurs during gestation until the cervix is soft at term, especially the nulliparous cervix . The progressive dilatation of the cervix needs uterine contraction during labor. A mechanical dilatation of the cervix at cesarean section is defined as an artificial dilatation of the cervix performed by finger, sponge forceps or other instruments at non-labor cesarean section. According to a cochrane view The information currently available about the advantages of cervical dilatation at cesarean section is inconclusive. This may be due to small sample sizes and low power of statistic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

January 2, 2018

Last Update Submit

September 22, 2019

Conditions

Caesarean Section

Outcome Measures

Primary Outcomes (1)

  • The amount of postpartum blood loss (ml)

    24 hours

Study Arms (2)

Group A: cervical dilatation

patients who will have cervical dilatation during Caesarean section

Procedure: Caesarean sectionOther: cervical dilatation

Group A: non cervical dilatation

patients who will have not cervical dilatation during Caesarean section

Procedure: Caesarean sectionOther: No cervical dilatation

Interventions

Caesarean sectionPROCEDURE

Caesarean section will be done to deliver the baby

Group A: cervical dilatationGroup A: non cervical dilatation
cervical dilatationOTHER

Cervical dilatation will be done by double gloves digital dilatation postpartum

Group A: cervical dilatation
No cervical dilatationOTHER

after delivery of the baby cervix will be remain closed

Group A: non cervical dilatation

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women who will subjected to elective Cesarean section

You may qualify if:

  • All women scheduled for elective cesarean section will be approached.
  • Women accepted to participate in the study participation after discussing the nature of the study.

You may not qualify if:

  • Immuno-compromised women.
  • Women suffering from any coagulation disorder or Blood disease.
  • Blood transfusion during surgery or before it.
  • History of wound infection or endometritis .
  • Ante partum hemorrhage.
  • History of long corticosteroid use.
  • Women refuse to participate in the study.
  • Suspected clinical evidence of infection.
  • anemic women
  • Multiple pregnancy
  • Preterm births
  • Rupture of membranes or chorioamnionitis
  • Women who use antibiotics during the last 24 hours due to any infection but not prophylactic antibiotic during caesarian section
  • Emergency caesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woman's Health Hospital

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

Cesarean SectionLabor Stage, First

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, OperativeLabor OnsetLabor, ObstetricPregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 5, 2018

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

September 24, 2019

Record last verified: 2019-09

Locations

EG(1)