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

Cairo University (CU)

Status: Completed

Conditions: Neonatal Hypoxia and Asphyxia

Treatments: Procedure: Cesarean section

Study type: Interventional

Funder types: Other

Identifiers

NCT03461913

32

Details and patient eligibility

About

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)

Full 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

Enrollment: 200 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

normal pregnancy

Active Comparator group

Description:

women at full term healthy pregnancy who underwent elective Cesarean section

Treatment:

Procedure: Cesarean section

pregnancy hypertension

Active Comparator group

Description:

women at full term pregnancy associated with hypertension who underwent elective Cesarean section

Treatment:

Procedure: Cesarean section