Pregnancy ComplicationsPA-Perinatal-ONCT07035899
Propofol Anesthesia and Perinatal Outcome
A study testing Caesarean Section in people with Pregnancy Complications and Anesthesia, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The effects of intravenous propofol administration for general anesthesia in cesarean deliveries on maternal and infant health will be evaluated in relation to maternal and umbilical cord blood propofol levels. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy Complications, Anesthesia
- What is being tested?
- Caesarean Section
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being pregnant in ASA category 1-2
- >39 weeks of healthy pregnancy
- >28 weeks complicated pregnancy
- Cesarean delivery with or without action
- Providing induction of general anesthesia with intravenous propofol
Who cannot join
- Pregnant women under the age of 18,
- Those who have stillbirth,
- Severe chronic kidney and liver disease,
- Neurological disease
- Those with other systemic diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Sultangazi, Istanbul, 34340
About this study
Official title: Association of Maternal and Neonatal Umbilical Cord Blood Levels of Propofol Administered for Induction of General Anesthesia With Perinatal Findings in Gravidas Undergoing Cesarean Section
The effects of intravenous propofol administration for general anesthesia in cesarean deliveries on maternal and infant health will be evaluated in relation to maternal and umbilical cord blood propofol levels.
Read the detailed description
After the ethics committee approval was obtained, volunteers who met the criteria for inclusion in the study were included in the study after obtaining their written permission. After the patients were taken to the operating room, IV catheterization was achieved after CTA, TA and sPO2 monitoring, and the patient was intubated 2 minutes after induction of propfol at 3 mg/kg and rocuronium at 0.6 mg/kg. After the baby was born, an intravenous blood sample was taken from the umbilical cord and the mother simultaneously. After the venous blood samples were obtained as 3 μL, the serum samples obtained by centrifugation as standard were portioned in equal volume to 500 μL Eppendorf tubes and stored at -80°C. After this pre-treatment, propofol was subjected to measurement tests with HPLC, and the collected data were added
- Conditions
- Pregnancy Complications, Anesthesia
- Being tested
- Caesarean Section
- Keywords
- Propofol, Pregnancy, Cesarean delivery, Perinatol outcome
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caesarean SectionDrug
Cesarean section was performed as routine surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Women with Healthy Pregnance undergone Caesarean Section | Sham comparator | Healthy Pregnant Women between the ages of 18 and 40 Receives: Drug: Caesarean Section |
| Women Compliceted Pregnance undergone Caesarean Section | Active comparator | Pregnant women between the ages of 18-40 with Pearclampsia, Preterm Labor, Fetal Growth Retardation, Gestational Diabetes Receives: Drug: Caesarean Section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood propofol concentration
ng/ml
Measured: The first 5 minutes of cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Aug 2023
- Primary completion1 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Observational
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Yilmaz Guler, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035899
- Sponsor's protocol ID
- PA-PN-O2024
- Acronym
- PA-Perinatal-O
- Status last verified
- Jun 2025
- First submitted
- 7 May 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Maternal and Neonatal Umbilical Cord Blood Levels of Propofol Administered for Induction of General Anesthesia With Perinatal Findings in Gravidas Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT07035899
- Acronym / sponsor ID
- PA-Perinatal-O / PA-PN-O2024
- Conditions
- Pregnancy Complications, Anesthesia
- Keywords
- Propofol, Pregnancy, Cesarean delivery, Perinatol outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effects of intravenous propofol administration for general anesthesia in cesarean deliveries on maternal and infant health will be evaluated in relation to maternal and umbilical cord blood propofol levels.
Detailed description
After the ethics committee approval was obtained, volunteers who met the criteria for inclusion in the study were included in the study after obtaining their written permission. After the patients were taken to the operating room, IV catheterization was achieved after CTA, TA and sPO2 monitoring, and the patient was intubated 2 minutes after induction of propfol at 3 mg/kg and rocuronium at 0.6 mg/kg. After the baby was born, an intravenous blood sample was taken from the umbilical cord and the mother simultaneously. After the venous blood samples were obtained as 3 μL, the serum samples obtained by centrifugation as standard were portioned in equal volume to 500 μL Eppendorf tubes and stored at -80°C. After this pre-treatment, propofol was subjected to measurement tests with HPLC, and the collected data were added
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Observational
| Arm | Type | Receives |
|---|---|---|
| Women with Healthy Pregnance undergone Caesarean Section | Sham comparator | Drug: Caesarean SectionHealthy Pregnant Women between the ages of 18 and 40 |
| Women Compliceted Pregnance undergone Caesarean Section | Active comparator | Drug: Caesarean SectionPregnant women between the ages of 18-40 with Pearclampsia, Preterm Labor, Fetal Growth Retardation, Gestational Diabetes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being pregnant in ASA category 1-2
- >39 weeks of healthy pregnancy
- >28 weeks complicated pregnancy
- Cesarean delivery with or without action
- Providing induction of general anesthesia with intravenous propofol
Key exclusion criteria (5 listed)
- Pregnant women under the age of 18,
- Those who have stillbirth,
- Severe chronic kidney and liver disease,
- Neurological disease
- Those with other systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caesarean SectionCesarean section was performed as routine surgical procedure | Drug | Women Compliceted Pregnance undergone Caesarean Section, Women with Healthy Pregnance undergone Caesarean Section |
Primary outcome
Blood propofol concentration
Time frame: The first 5 minutes of cesarean delivery
ng/ml
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caesarean Section in people with Pregnancy Complications and Anesthesia, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood propofol concentration (time frame: The first 5 minutes of cesarean delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.