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CompletedNCT03461913Updated Mar 12, 2018

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

An interventional study of Cesarean section in Neonatal Hypoxia and Asphyxia, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-03-12.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Sep 2016, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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)

Read the 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

02

Conditions studied

  • Neonatal Hypoxia and Asphyxia
03

In context

Asphyxia Neonatorum

106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.

This study's enrollment of 200 is above the median of 173 across 73 interventional studies indexed under Asphyxia Neonatorum.

Browse Asphyxia Neonatorum studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    normal pregnancy

    women at full term healthy pregnancy who underwent elective Cesarean section

    Procedure: Cesarean section

  • Active comparator
    pregnancy hypertension

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

    Procedure: Cesarean section

Interventions

  • ProcedureCesarean section

    Lower segment elective Cesarean section

    Also known as: Elective Cesarean section

06

What researchers measure

Primary outcomes

  1. umbilical cord Ph

    umbilical cords were clamped on both ends and an arterial blood sample was collected anaerobically in a pre-heparinized insulin syringe

    Time frame: immediately after delivery

Secondary outcomes

  1. Apgar score

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

    Time frame: 1 and 5 minutes after delivery

07

Study locations

1 site
  • Kasr Alainy medical school
    Cairo, 12111, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03461913
Lead sponsor
Cairo University
Responsible party
Ahmed Maged (professor, Cairo University) — Principal investigator
First posted
Mar 12, 2018
Start date
Sep 1, 2016
Primary completion
Oct 29, 2017
Completion
Mar 5, 2018
Last update
Mar 12, 2018

Study contacts

Ahmed Maged, MD
principal investigator · professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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