UnknownPhase 4

Colloid Preload Versus Colloid Coload During Cesarean Deliveries

Turkey (Türkiye)200 participantsStarted 2015-03

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years or older * Singleton pregnancy * Gestational age ≥ 37 weeks * Height ≥ 150 cm and ≤ 180 cm * Weight \> 50 kg and \< 100 kg Exclusion Criteria: * Gestational age \> 37 weeks * Multiple pregnancies * Fetal distress * Preeclampsia * Cardiovascular disease and diabetes * Hematological problems * Local infection at intervention site * Abnormal coagulation tests * Anticoagulant use * Starch allergy * Height \< 150 cm and \> 180 cm * Weight \< 50 kg and \> 100 kg

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maternal hypotension.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Heart rate.

Timeframe: 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.

Trial details

NCT IDNCT02393196

SponsorSifa University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01

Contact for this trial

Aysun Afife Kar, MD

+905326521313 aaysunkar@hotmail.com

View on ClinicalTrials.gov More Anesthesia; Adverse Effect, Spinal and Epidural trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maternal hypotension.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Heart rate.

Timeframe: 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.