NCT03461913

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
Last Updated

March 12, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

March 6, 2018

Last Update Submit

March 9, 2018

Conditions

Neonatal Hypoxia and Asphyxia

Outcome Measures

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

    immediately after delivery

Secondary Outcomes (1)

  • Apgar score

    1 and 5 minutes after delivery

Study Arms (2)

normal pregnancy

ACTIVE COMPARATOR

women at full term healthy pregnancy who underwent elective Cesarean section

Procedure: Cesarean section

pregnancy hypertension

ACTIVE COMPARATOR

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

Procedure: Cesarean section

Interventions

Cesarean sectionPROCEDURE

Lower segment elective Cesarean section

Also known as: Elective Cesarean section
normal pregnancypregnancy hypertension

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

MeSH Terms

Conditions

Asphyxia NeonatorumAsphyxia

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmed Maged, MD

    professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 12, 2018

Study Start

September 1, 2016

Primary Completion

October 29, 2017

Study Completion

March 5, 2018

Last Updated

March 12, 2018

Record last verified: 2018-03

Locations

EG(1)