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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03461913
Enrollment
200
Registered
2018-03-12
Start date
2016-09-01
Completion date
2018-03-05
Last updated
2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Hypoxia and Asphyxia

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

Interventions

PROCEDURECesarean section

Lower segment elective Cesarean section

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
umbilical cord Phimmediately after deliveryumbilical cords were clamped on both ends and an arterial blood sample was collected anaerobically in a pre-heparinized insulin syringe

Secondary

MeasureTime frameDescription
Apgar score1 and 5 minutes after deliveryassessment of Appearance, Pulse, Grimace, Activity, and Respiration

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026