- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07406841
Spinal Versus General Anesthesia in Pregnancies With Placenta Accreta Spectrum: A Retrospective Comparative Study (SAGA-PAS)
Comparison of Spinal and General Anesthesia on Maternal and Neonatal Outcomes in Pregnancies With Placenta Accreta Spectrum: A Retrospective Study
Placenta accreta spectrum (PAS) is a serious pregnancy complication in which the placenta grows abnormally into the uterine wall. This condition is associated with a high risk of severe bleeding, need for blood transfusion, hysterectomy, and maternal complications during cesarean delivery.
This study aims to compare spinal anesthesia and general anesthesia in pregnant women diagnosed with placenta accreta spectrum who underwent cesarean delivery. The researchers reviewed existing medical records to evaluate differences in maternal and neonatal outcomes between the two anesthesia approaches.
The primary outcomes include changes in hemoglobin levels before and after surgery, the need for uterotonic medications during and after the operation, and newborn Apgar scores. Because this is a retrospective observational study, no new treatments were given, and all data were collected from routine clinical care records.
The findings are expected to help guide anesthetic decision-making in PAS cases, improve maternal and neonatal safety, and contribute to the international scientific literature on this topic.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single-center, retrospective observational study conducted in pregnant patients diagnosed with placenta accreta spectrum (PAS) who underwent cesarean delivery at Gaziantep City Hospital. Medical records were reviewed to identify eligible cases between the predefined study period based on imaging findings, intraoperative diagnosis, and/or histopathological confirmation of PAS.
Patients were categorized according to the type of anesthesia received during cesarean delivery: spinal anesthesia or general anesthesia. The choice of anesthetic technique was based on routine clinical practice, multidisciplinary team decision, and individual patient characteristics, rather than random assignment. No additional interventions were introduced for research purposes.
Data were extracted from electronic medical records, anesthesia charts, obstetric files, and neonatal records. Collected variables included demographic characteristics, obstetric history, imaging findings suggestive of PAS, intraoperative management strategies, estimated blood loss, transfusion requirements, use of uterotonic agents, and perioperative hemodynamic parameters. Neonatal data included gestational age at delivery, birth weight, Apgar scores at 1 and 5 minutes, need for resuscitation, and admission to neonatal intensive care.
The primary analytic focus was the comparison of perioperative hemoglobin change between the spinal and general anesthesia groups. Secondary analyses evaluated differences in intraoperative and postoperative uterotonic requirements, transfusion needs, surgical complications, length of hospital stay, and neonatal outcomes.
Statistical analyses were performed using appropriate parametric or non-parametric tests depending on data distribution. Potential confounding factors such as placenta previa status, prior cesarean history, and PAS severity were considered in subgroup analyses.
Ethics approval was obtained from the Gaziantep City Hospital Clinical Research Ethics Committee prior to data collection, and patient confidentiality was maintained in accordance with national regulations and the Declaration of Helsinki.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Recep Karakaşoğlu, MD
- Phone Number: +905364668718
- Email: erecep_1992@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant patients diagnosed with placenta accreta spectrum (PAS), Undergoing elective cesarean delivery, Receiving either spinal anesthesia or general anesthesia during cesarean section, Singleton pregnancy, Availability of complete medical and anesthesia records related to surgery and perioperative management
Exclusion Criteria:
Patients without a diagnosis of PAS, Emergency (non-elective) cesarean deliveries, Use of anesthesia techniques other than spinal or general anesthesia, Multiple pregnancy (twins or more) ,Incomplete or missing medical/anesthesia records, Missing key perioperative or neonatal outcome data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Spinal Anesthesia
This cohort includes pregnant patients diagnosed with placenta accreta spectrum who underwent cesarean delivery under spinal anesthesia as part of routine clinical care.
The anesthetic technique was selected by the multidisciplinary clinical team based on standard institutional practice and individual patient characteristics.
No experimental intervention was applied for research purposes.
|
Spinal anesthesia administered for cesarean delivery as part of routine clinical care in pregnant patients with placenta accreta spectrum.
The technique was chosen by the clinical team based on standard institutional practice and patient condition, not for research assignment.
|
|
General Anesthesia
This cohort includes pregnant patients diagnosed with placenta accreta spectrum who underwent cesarean delivery under general anesthesia as part of routine clinical care.
The anesthetic technique was selected by the multidisciplinary clinical team based on standard institutional practice and individual patient characteristics.
No experimental intervention was applied for research purposes.
|
General anesthesia was administered for cesarean delivery in pregnant patients with placenta accreta spectrum as part of routine clinical care.
The anesthetic technique, including airway management, induction agents, and maintenance strategy, was selected by the attending anesthesia team according to institutional standards and the patient's clinical condition.
The intervention was not assigned for research purposes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of Hospital Stay to Discharge
Time Frame: Postoperative day of hospital discharge, assessed up to 30 days after cesarean delivery.
|
Total duration of maternal hospitalization calculated from the time of cesarean delivery until official hospital discharge.
|
Postoperative day of hospital discharge, assessed up to 30 days after cesarean delivery.
|
|
Perioperative Hemoglobin Change
Time Frame: From preoperative assessment to 48 hours after cesarean delivery
|
The difference between preoperative hemoglobin level and postoperative hemoglobin level measured within the first 48 hours after cesarean delivery in patients with placenta accreta spectrum.
|
From preoperative assessment to 48 hours after cesarean delivery
|
|
Neonatal Apgar Score at 1 and 5 Minutes
Time Frame: At 1 minute and 5 minutes after birth
|
Neonatal Apgar scores assessed at 1 and 5 minutes after birth in infants delivered by cesarean section in pregnancies with placenta accreta spectrum.
|
At 1 minute and 5 minutes after birth
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GZŞH-ANES-PAS-2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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