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

Neonatal Hypoxia and Asphyxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461913
• Other study ID #: 32
• Status: Completed
• Phase: N/A
• First received: March 6, 2018
• Last updated: March 9, 2018
• Start date: September 1, 2016
• Est. completion date: March 5, 2018

Study information

• Verified date: March 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 5, 2018
• Est. primary completion date: October 29, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia
• Hypertension
• Hypoxia
• Neonatal Hypoxia and Asphyxia

Intervention

Procedure:
• Cesarean section
Lower segment elective Cesarean section

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Apgar score	assessment of Appearance, Pulse, Grimace, Activity, and Respiration	1 and 5 minutes after delivery