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

NCT03444792 | Completed

• 1 other identifier: cervical dilatation
• Study Type: interventional
• Target: 774
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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

  the 1st 24 hours postoperative.

Secondary Outcomes (2)

• intraoperative blood loss

  during the time of the operation

• Total blood loss

  operation time plus the 1st 24 hours after operation

Study Arms (2)

Group I (dilation group)

EXPERIMENTAL

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

Group II (non dilatation group)

NO INTERVENTION

the surgeon will perform cesarian section without attempting cervical dilatation

Interventions

mechanical dilatation of the cervix PROCEDURE

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

Group I (dilation group)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine Cairo University

Cairo, 11231, Egypt

Location

MeSH Terms

Conditions

Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• mohamed sharkawy, assis.prof.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The included patients will be randomized using sealed opaque envelope method into two groups
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in obstetrics and gynecology

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 23, 2018
• Study Start: February 10, 2018
• Primary Completion: June 15, 2018
• Study Completion: June 20, 2018
• Last Updated: July 6, 2018

Record last verified: 2018-07

Locations

EG (1)