Can Shorter Time Intervals Help the Baby Survive the Triad Effect of Maternal Hypertension, Caesarean Section and Spinal Anesthesia?

Study Overview
=================
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

Official Title
-----------------
Can Shorter Time Intervals Help the Baby Survive the Triad Effect of Maternal Hypertension, Caesarean Section and Spinal Anesthesia?

Conditions
-----------------
Neonatal Hypoxia and Asphyxia

Intervention / Treatment
-----------------
* Procedure: Cesarean section


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: normal pregnancy<br>women at full term healthy pregnancy who underwent elective Cesarean section | Procedure: Cesarean section<br>* Lower segment elective Cesarean section<br>* Other names: Elective Cesarean section;|
| Active Comparator: pregnancy hypertension<br>women at full term pregnancy associated with hypertension who underwent elective Cesarean section | Procedure: Cesarean section<br>* Lower segment elective Cesarean section<br>* Other names: Elective Cesarean section;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| umbilical cord Ph | umbilical cords were clamped on both ends and an arterial blood sample was collected anaerobically in a pre-heparinized insulin syringe | immediately after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apgar score | assessment of Appearance, Pulse, Grimace, Activity, and Respiration | 1 and 5 minutes after delivery |