Investigating Maternal Effects of Positions Applied in Patients Preparing for Caesarean Section Under Spinal Anesthesia

NCT05595928 | Unknown

• 1 other identifier: 2022-10
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

After the approval of the Ethics Committee, 120 patients were planned to be included in the study between 15.06.2022 and 15.01.2023. Women who underwent elective cesarean delivery under spinal anesthesia were randomized to the supine position, 15° left-lateral tilt position, or 30° left-lateral tilt position. The position will be changed to supine before the incision. It was planned to recruit 40 patients from each group, with a total of 120 patients. Anesthetic management was standardized and fluid administration with 10 mL/kg isotonic was planned. Hypotension (systolic blood pressure \[SBP\] reduction \> 20% baseline or SBP \<90 mm Hg) will be treated with intravenous bolus ephedrine based on maternal heart rate. The primary outcome is planned to include maternal SBP in 15 minutes of anesthesia induction, the amount of vasoactive drug administered before the end of surgery, and the incidence of hypotension during cesarean delivery.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• position

  the purpose was to investigate the maternal effects between supine, tilt to the left of 15-degree, and tilt to the left of 30-degree.

  through study completion, an average of 6 months

Study Arms (3)

Supine

supine

Other: position

15° left-lateral tilt position

15° left-lateral tilt position.

Other: position

30° left-lateral tilt position.

30° left-lateral tilt position.

Other: position

Interventions

position OTHER

To compare whether there is a difference between maternal and fetal effects of Supine, 15-degree left tilt, and 30-degrees left tilt.

15° left-lateral tilt position; 30° left-lateral tilt position.; Supine

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Since there are patients who will undergo cesarean section, female patients are included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who underwent elective cesarean delivery under spinal anesthesia

You may qualify if:

• Elective cesarean delivery with term pregnancy
• Patient's height 150-180 cm
• American Society of Anesthesiologists (ASA) Physical Condition II
• Body Mass Index (BMI) \<35 kg/m2.

You may not qualify if:

• Fetal macrosomia
• Uterine abnormalities (e.g. large fibroids, bicornuate uterus)
• Polyhydramnios
• Torn membranes, oligohydramnios
• Intrauterine growth restriction
• Gestational or non-gestational hypertension, diabetes, or eclampsia
• Contraindications for spinal anesthesia

Sponsors & Collaborators

• Aydin Maternity and Child Health Hospital: lead

Study Sites (1)

Aydin Maternity and Child Health Hospital

Aydin, Turkey (Türkiye)

Location

Related Publications (1)

• Liu T, Zou S, Guo L, Niu Z, Wang M, Xu C, Gao X, Shi Z, Guo X, Xiao H, Qi D. Effect of Different Positions During Surgical Preparation With Combined Spinal-Epidural Anesthesia for Elective Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2021 Nov 1;133(5):1235-1243. doi: 10.1213/ANE.0000000000005320.

  PMID: 33350619 RESULT

MeSH Terms

Conditions

Hypotension

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• FERDİ GÜLAŞTI

  Aydin Maternity and Child Health Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aydin Maternity and Child Health Hospital

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 27, 2022
• Study Start: June 15, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)