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Completed

NCT Number: NCT03461913

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

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)

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Key information

Conditions

Neonatal Hypoxia and Asphyxia Asphyxia Asphyxia Neonatorum Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy medical school

Cairo, 12111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cesarean section

Procedure

Lower segment elective Cesarean section

Other names: Elective Cesarean section

Primary outcomes

  1. umbilical cord Ph

    Time frame: 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 outcomes

  1. Apgar score

    Time frame: 1 and 5 minutes after delivery

    assessment of Appearance, Pulse, Grimace, Activity, and Respiration

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 12, 2018
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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