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Mechanical Dilatation of the Cervix at Elective Caesarean Section to Reduce Post-Operative Blood Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03444792
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Samy aly ashour, Cairo University

Brief Summary:

obstetric hemorrhage remains one of the major causes of maternal death in both developed and developing countries. Because of its importance as a leading cause of maternal mortality and morbidity, and because of evidence of substandard care in the majority of fatal cases, obstetric hemorrhage must be considered as a priority topic for national guideline development.

Some obstetricians believe that the cervix of women at non-labor cesarean section is undilated and might cause obstruction of blood or lochia drainage, leading to postpartum hemorrhage and endometritis from the collection of lochia or debris. Dilatation of the cervix helps with the drainage of blood during postpartum, reducing intrauterine infection or the risk of postpartum hemorrhage. To avoid this problem, some obstetricians routinely dilate the cervix from above during an elective/ non-labor cesarean section using finger, sponge forceps or other instruments


Condition or disease Intervention/treatment Phase
Post Operative Hemorrhage Procedure: mechanical dilatation of the cervix Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 774 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The included patients will be randomized using sealed opaque envelope method into two groups
Primary Purpose: Prevention
Official Title: Mechanical Dilatation vs Non-Dilatation of the Cervix at Elective Caesarean Section to Reduce Post-Operative Blood Loss
Actual Study Start Date : February 10, 2018
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (dilation group)
the surgeon will perform the cervical dilatation by inserting the double-gloved index finger into the cervical canal of the patients after the extraction of placenta and membranes. The outer glove will be removed after this procedure. - If failed we will use artery forceps to dilate cervix
Procedure: mechanical dilatation of the cervix

the surgeon will perform the cervical dilatation by inserting the double-gloved index finger into the cervical canal of the patients after the extraction of placenta and membranes. The outer glove will be removed after this procedure.

- If failed the surgeon will use artery forceps to dilate cervix


No Intervention: Group II (non dilatation group)
the surgeon will perform cesarian section without attempting cervical dilatation



Primary Outcome Measures :
  1. Vaginal bleeding during the 1st 24 hours postoperative. [ Time Frame: the 1st 24 hours postoperative. ]
    The amount of vaginal bleeding will be calculated according to number of soaked pads used after the cesarean section for the 1st 24 hours. Where each soaked pad = 50 cc


Secondary Outcome Measures :
  1. intraoperative blood loss [ Time Frame: during the time of the operation ]

    Blood loss will be estimated by the anesthesia service to guard against potential surgeon bias.

    Operative blood loss will be calculated from the amount of blood in the suction bottle after delivery of the placenta and the number of towels used and to which degree they were socked.

    Blood from the uterine incision, soaked towels and blood in suction bottle before placental delivery will not be added to the blood measurements.

    Soaked towel = 150 cc. Semi-soaked towel = 75 cc. blood measurements. Soaked towel = 150 cc. Semi-soaked towel = 75 cc.


  2. Total blood loss [ Time Frame: operation time plus the 1st 24 hours after operation ]
    intraoperative blood loss plus potoperative blood loss



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pregnant women with a single term fetus >37 weeks of gestational age, with American Society of Anesthesiology (ASA) physical status I or II undergoing Elective Cs (primary or repeated CS).
  • Age group 20 - 35 years old

Exclusion Criteria:

  • Chorioamnionitis.
  • Placenta previa.
  • Multiple gestations.
  • Preeclampsia.
  • Macrosomia.
  • Hydramnios.
  • Uterine leiomyomata.
  • Anemia.
  • Previous cervical surgery.
  • Previous post-partum hemorrhage.
  • Bleeding tendency.
  • Hypertension.
  • Diabetes mellitus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444792


Locations
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Egypt
Faculty of Medicine Cairo University
Cairo, Egypt, 11231
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: mohamed sharkawy, assis.prof. Cairo University

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Responsible Party: Ahmed Samy aly ashour, lecturer in obstetrics and gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT03444792     History of Changes
Other Study ID Numbers: cervical dilatation
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hemorrhage
Blood Loss, Surgical
Postoperative Hemorrhage
Pathologic Processes
Intraoperative Complications
Postoperative Complications