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

NCT ID: NCT03461913

Last Updated: 2018-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-03-05

Brief Summary

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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

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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

Conditions

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Neonatal Hypoxia and Asphyxia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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normal pregnancy

women at full term healthy pregnancy who underwent elective Cesarean section

Group Type ACTIVE_COMPARATOR

Cesarean section

Intervention Type PROCEDURE

Lower segment elective Cesarean section

pregnancy hypertension

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

Group Type ACTIVE_COMPARATOR

Cesarean section

Intervention Type PROCEDURE

Lower segment elective Cesarean section

Interventions

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Cesarean section

Lower segment elective Cesarean section

Intervention Type PROCEDURE

Other Intervention Names

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Elective Cesarean section

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Maged

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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32

Identifier Type: -

Identifier Source: org_study_id

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