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

Not Applicable

Completed

• Conditions: Neonatal Hypoxia and Asphyxia
• Interventions: Procedure: Cesarean section

• Registration Number: NCT03461913
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2017-10-29
• Status Verified: 2018-03
• Study Completion: 2018-03-05
• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-09
• Last Update Submitted: 2018-03-09
• Study First Posted: 2018-03-12
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• full term pregnancy
• singleton pregnancy
• no medical disorders except hypertension in group 2

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal pregnancy	Cesarean section	women at full term healthy pregnancy who underwent elective Cesarean section
pregnancy hypertension	Cesarean section	women at full term pregnancy associated with hypertension who underwent elective Cesarean section

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Apgar score	1 and 5 minutes after delivery	assessment of Appearance, Pulse, Grimace, Activity, and Respiration

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt