Back to resultsCan Shorter Time Intervals Help the Baby Survive the Triad Effect of Maternal Hypertension, Caesarean Section and Spinal Anesthesia?
Primary Purpose
Neonatal Hypoxia and Asphyxia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cesarean section
Sponsored by
About this trial
This is an interventional prevention trial for Neonatal Hypoxia and Asphyxia
Eligibility Criteria
Inclusion Criteria:
- full term pregnancy
- singleton pregnancy
- no medical disorders except hypertension in group 2
Exclusion Criteria:
- Multiple pregnancies
- complicated pre-eclamptic cases as placental abruption, eclampsia or HELLP syndrome,
- preterm pregnancies,
- true knots of the cord
- reduced liquor,
- in labour patients,
- fetal distress
- infants with major congenital malformations
Sites / Locations
- Kasr Alainy medical school
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
normal pregnancy
pregnancy hypertension
Arm Description
women at full term healthy pregnancy who underwent elective Cesarean section
women at full term pregnancy associated with hypertension who underwent elective Cesarean section
Outcomes
Primary Outcome Measures
umbilical cord Ph
umbilical cords were clamped on both ends and an arterial blood sample was collected anaerobically in a pre-heparinized insulin syringe
Secondary Outcome Measures
Apgar score
assessment of Appearance, Pulse, Grimace, Activity, and Respiration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03461913
Brief Title
Can Shorter Time Intervals Help the Baby Survive the Triad Effect of Maternal Hypertension, Caesarean Section and Spinal Anesthesia?
Official Title
Can Shorter Time Intervals Help the Baby Survive the Triad Effect of Maternal Hypertension, Caesarean Section and Spinal Anesthesia?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
October 29, 2017 (Actual)
Study Completion Date
March 5, 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients were classified into two equal groups using the presence or absence of hypertension during pregnancy into: hypertensive group (BP>140/90) and normotensive group (BP≤140/90. The surgical time intervals are assessed and classified the patients accordingly into short and log time interval subgroups (induction of regional anesthesia to delivery (I-D), initial skin incision to delivery (S-D), and uterine incision to delivery (U-D)
Detailed Description
Surgical times components; induction of regional anesthesia till delivery (I-D interval); incision of the skin till delivery (S-D interval); and incision of the uterus till delivery (U-D interval)) were recorded using a stopwatch.
Immediately after delivery, umbilical cords were clamped on both ends and an arterial blood sample was collected anaerobically in a pre-heparinized insulin syringe. PH, base excess (BE), carbon dioxide pressure (PCO2), Oxygen pressure (PO2) and Bicarbonate (HCO3) levels were measured at 37oC by pH and gas analyzer (Gem, Premier3000, USA). The gas analysis was done in less than 30 minutes after sampling.
Apgar score was assessed by a neonatologist at the 1st and 5th minutes after birth . Advanced resuscitation included positive pressure ventilation, chest compression and/or drugs administration. All resuscitated babies were transferred to neonatal intensive care unit for post resuscitation care. Fetal distress was defined by an umbilical cord pH <7.12
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hypoxia and Asphyxia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
normal pregnancy
Arm Type
Active Comparator
Arm Description
women at full term healthy pregnancy who underwent elective Cesarean section
Arm Title
pregnancy hypertension
Arm Type
Active Comparator
Arm Description
women at full term pregnancy associated with hypertension who underwent elective Cesarean section
Intervention Type
Procedure
Intervention Name(s)
Cesarean section
Other Intervention Name(s)
Elective Cesarean section
Intervention Description
Lower segment elective Cesarean section
Primary Outcome Measure Information:
Title
umbilical cord Ph
Description
umbilical cords were clamped on both ends and an arterial blood sample was collected anaerobically in a pre-heparinized insulin syringe
Time Frame
immediately after delivery
Secondary Outcome Measure Information:
Title
Apgar score
Description
assessment of Appearance, Pulse, Grimace, Activity, and Respiration
Time Frame
1 and 5 minutes after delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
full term pregnancy
singleton pregnancy
no medical disorders except hypertension in group 2
Exclusion Criteria:
Multiple pregnancies
complicated pre-eclamptic cases as placental abruption, eclampsia or HELLP syndrome,
preterm pregnancies,
true knots of the cord
reduced liquor,
in labour patients,
fetal distress
infants with major congenital malformations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Can Shorter Time Intervals Help the Baby Survive the Triad Effect of Maternal Hypertension, Caesarean Section and Spinal Anesthesia?
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