NCT02393196|UnknownPhase 4DMC
Loading search results
Sponsor study identifier
interventional
200
1 country
1
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The investigators aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. The second aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest approach for the clinician.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
March 1, 2015
Actual (reported)March 19, 2015
Actual (reported)January 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Maternal hypotension.
Maternal hypotension will be defined as at least a single administration of ephedrine within the period from induction of SA to the delivery (umbilical cord clamping). After spinal anesthesia, SAP will be measured and recorded at every minute until birth and every three minutes thereafter.
Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Incidence of severe hypotension.
Incidence of severe hypotension (SAP \< 70% of the baseline value or SAP \< 80 mmHg) will be recorded.
Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Cumulative duration of hypotension.
Cumulative duration of hypotension will be recorded from induction of spinal anesthesia until delivery (umbilical cord clamping).
Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Neonatal effects.
Time just after delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Ephedrine treatment.
Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Nausea and/or vomiting.
Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Preoperative fasting period.
Time before spinal anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days.
Preoperative hemoglobin concentration (g/dL).
Time before spinal anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days.
Durations of anesthesia and surgery.
Time between induction of spinal anesthesia until end of the anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days.
Group Preloading (Group P): 500 mL hydroxyethyl starch (6% HES 130/0.4) (Voluven®; Fresenius Kabi, Bad Homburg, Germany) will be infused via a pressure infusion system at a maximum speed as possible before spinal anesthesia.
Group Coloading (Group C): After the patients have been monitored, spinal anesthesia will be performed. Recognizing the cerebrospinal fluid, 500 mL hydroxyethyl starch (%6 HES 130/0.4) (Voluven®; Fresenius Kabi, Bad Homburg, Germany) will be infused via a pressure infusion system at a maximum speed as possible.
Before spinal anesthesia
Just after spinal anesthesia
Şifa Üniversitesi, Basmane Hastanesi
Izmir, 35100, Turkey (Türkiye)
Aysun Afife Kar, MD
Şifa Üniversitesi, Basmane Hastanesi, İzmir, Turkey
First Submitted
March 1, 2015
First Posted
March 19, 2015
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Heart rate.
Minimum and maximum heart rate, bradycardia, atropine usage will be recorded.
Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 17, 2015
Record last verified: 2015-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: