NCT07035899

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

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

August 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

May 7, 2025

Last Update Submit

June 16, 2025

Conditions

Pregnancy ComplicationsAnesthesia

Keywords

PropofolPregnancyCesarean deliveryPerinatol outcome

Outcome Measures

Primary Outcomes (1)

  • Blood propofol concentration

    ng/ml

    The first 5 minutes of cesarean delivery

Study Arms (2)

Women with Healthy Pregnance undergone Caesarean Section

SHAM COMPARATOR

Healthy Pregnant Women between the ages of 18 and 40

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

Drug: Caesarean Section

Interventions

Caesarean SectionDRUG

Cesarean section was performed as routine surgical procedure

Women Compliceted Pregnance undergone Caesarean SectionWomen with Healthy Pregnance undergone Caesarean Section

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant women under the age of 18,
  • Those who have stillbirth,
  • Severe chronic kidney and liver disease,
  • Neurological disease
  • Those with other systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Research Hospital

Sultangazi, Istanbul, 34340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetric Anesthesia Specialist

Study Record Dates

First Submitted

May 7, 2025

First Posted

June 25, 2025

Study Start

August 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 30, 2024

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)