Anesthesia; Adverse Effect Clinical Trial
Official title:
Does the Mode of Anesthesia Affect the Feto-maternal Outcome in Category-1 Caesarean Section: A Prospective Non-randomized Study Comparing Spinal Versus General Anesthesia
Verified date | November 2020 |
Source | Benha University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Spinal anesthesia (SA) has become the standard technique in elective cesarean section (CS) as it results in less maternal and neonatal morbidity than general anesthesia (GA) (Grade-A recommendation, NICE). For women requiring emergency CS, rapid sequence general anesthesia (RSGA) is commonly used because this technique is faster to perform than SA. Though several randomized trials have compared the maternal and fetal outcome between these two anesthetic techniques, the studies with respect to category 1 CS (emergent conditions that hold immediate threat to life of the woman or fetus) are limited.
Status | Completed |
Enrollment | 74 |
Est. completion date | February 15, 2021 |
Est. primary completion date | January 30, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | following inclusion criteria: - American Society of Anesthesiologists physical status (ASA) < III - Age 18-40 year - Gestational age>37 weeks - Emergency cesarean delivery - Singleton pregnancy The exclusion criteria are: - Twin pregnancy - Disagreement of the patient - Neurological impairment - Congenital fetal abnormality - body mass index > 40 kg/m2; and - Sensitivity to any of the drugs used during the emergency CS. |
Country | Name | City | State |
---|---|---|---|
Egypt | Samar Rafik Mohamed Amin | Banha | Qalubia |
Lead Sponsor | Collaborator |
---|---|
Benha University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | APGAR score | Apgar score is a method for assessment of neonatal well-being after birth (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition) | 5 minutes after delivery | |
Secondary | decision-to-delivery interval (DDI) | the interval in minutes from the time of the decision by obstetrician to the time of delivery of the baby | from decision to operate till delivery of the baby | |
Secondary | Umbilical cord PH | Arterial blood gases from umbilical cord artery were used to assess newborn's acid-base status | immediately after delivery | |
Secondary | Occurrence of maternal complications postoperative | all mother were followed for any postoperative complications related to the anesthesia. | from recovery from anesthesia up to 24 hours postoperative | |
Secondary | Neonatal ICU admission | Admission to the NICU in percentage of the total participants. | from delivery of the baby up to 24 hour postoperative | |
Secondary | Length of hospital stay | Length of stay (LOS) is the duration of a single episode of hospitalization | up to 1 month |
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