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

Primary Purpose

Post Operative Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mechanical dilatation of the cervix
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Hemorrhage

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group I (dilation group)

Group II (non dilatation group)

Arm Description

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

the surgeon will perform cesarian section without attempting cervical dilatation

Outcomes

Primary Outcome Measures

Vaginal bleeding during 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

intraoperative blood loss
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.
Total blood loss
intraoperative blood loss plus potoperative blood loss

Full Information

First Posted
February 19, 2018
Last Updated
July 3, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03444792
Brief Title
Mechanical Dilatation of the Cervix at Elective Caesarean Section to Reduce Post-Operative Blood Loss
Official Title
Mechanical Dilatation vs Non-Dilatation of the Cervix at Elective Caesarean Section to Reduce Post-Operative Blood Loss
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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

5. Study Description

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
Detailed Description
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. Obstetric hemorrhage encompasses both antepartum and postpartum bleeding. The direct pregnancy-related maternal mortality rate in the United States is approximately 7-10 women per 100,000 live births. National statistics suggest that approximately 8% of these deaths are caused by Post Partum Hemorrhage (PPH). In industrialized countries, PPH usually ranks in the top 3 causes of maternal mortality, along with embolism and hypertension. In the developing world, several countries have maternal mortality rates in excess of 1000 women per 100,000 live births, and World Health Organization statistics suggest that 25% of maternal deaths are due to PPH, accounting for more than 100,000 maternal deaths per year . The most recent Practice Bulletin from the American College of Obstetricians and Gynecologists places the estimate at 140,000 maternal deaths per year or 1 woman every 4 minutes. The rate of PPH increased from 1.5% in 1999 to 4.1% in 2009, and the rate of atonic PPH rose from 1% in 1999 to 3.4% in 2009. In the triennium 2006-2008, 261 women in the UK died directly or indirectly related to pregnancy. The overall maternal mortality rate was 11.39 per 100,000 maternities. Direct deaths decreased from 6.24 per 100,000 maternities in 2003-2005 to 4.67 per 100,000 maternities in 2006-2008 (p = 0.02). The number of deaths from postpartum hemorrhage (PPH) has halved to five. In many countries cesarean section (CS) has become the mode of delivery in over a quarter of all births. It is the most commonly performed operation in obstetrics. Infectious morbidity is the most frequent complication of cesarean delivery. Of women who have caesareans, 5-24% have clinically significant fevers; and 6-21% are diagnosed with uterine infections (endomyometritis or endometritis), 1- 5% with more extensive pelvic infections including abscesses and 2-9% with a breakdown of the surgical incision, most often caused by wound infection. Strategies to minimize postoperative infectious and other morbidities have included modifications of surgical technique, changing of gloves, methods of placental delivery and altering the uterine position during repair of the uterine incision. However, none of these studies have evaluated the dilatation of the cervix during elective CS. The practice of routine cervical dilatation at elective cesarean section is performed by some surgeons to facilitate discharge of lochia from a uterus that was not in labor in the immediate postoperative period. 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.An important concern when dilating the cervix in a non-labor uterus is the theoretical risk of ascending infection to the uterus from the vagina, abdominal cavity and abdominal incision. In addition, cervical dilatation may be associated with the creation of a false passage or hemorrhage from cervical injury. However, an undilated cervix may prevent discharge of lochia following elective CS with retention of lochia, a potential culture medium for bacteria, which can cause puerperal genital tract infection. Some published data from developed countries have suggested that there is no difference in outcome between a practice of routine cervical dilatation or non- dilatation at elective cesarean section. Turnbull's Obstetrics mentions using an extra glove on the left hand to dilate the cervix. The information currently available about the advantages of cervical dilatation at cesarean section is inconclusive. Therefore, evidence to support the effectiveness or safety of cervical dilatation at cesarean section is needed .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Masking Description
The included patients will be randomized using sealed opaque envelope method into two groups
Allocation
Randomized
Enrollment
774 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (dilation group)
Arm Type
Experimental
Arm Description
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
Arm Title
Group II (non dilatation group)
Arm Type
No Intervention
Arm Description
the surgeon will perform cesarian section without attempting cervical dilatation
Intervention Type
Procedure
Intervention Name(s)
mechanical dilatation of the cervix
Intervention Description
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
Primary Outcome Measure Information:
Title
Vaginal bleeding during the 1st 24 hours postoperative.
Description
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
Time Frame
the 1st 24 hours postoperative.
Secondary Outcome Measure Information:
Title
intraoperative blood loss
Description
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.
Time Frame
during the time of the operation
Title
Total blood loss
Description
intraoperative blood loss plus potoperative blood loss
Time Frame
operation time plus the 1st 24 hours after operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed sharkawy, assis.prof.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Cairo University
City
Cairo
ZIP/Postal Code
11231
Country
Egypt

12. IPD Sharing Statement

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