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OpenTrials
Completed

NCT Number: NCT03392077

Digital Cervical and Cesarean Section

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Woman's Health Hospital

Asyut, 71111, Egypt

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Caesarean section

Procedure

Caesarean section will be done to deliver the baby

cervical dilatation

Other

Cervical dilatation will be done by double gloves digital dilatation postpartum

No cervical dilatation

Other

after delivery of the baby cervix will be remain closed

Primary outcomes

  1. The amount of postpartum blood loss (ml)

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

The Role of Digital Cervical Opening in Elective Cesarean Section

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 5, 2018
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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