Clinical trial NCT05595928: Investigating Maternal Effects of Positions Applied in Patients Preparing for Caesarean Section Under Spinal Anesthesia
Official title: Investigating Maternal Effects of Positions Applied in Patients Preparing for Caesarean Section Under Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypotension
Lead sponsor: Aydin Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who underwent elective cesarean delivery under spinal anesthesia

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.

Detailed description: Pregnant women in the supine position may compress the Inferior Vena Cava (IVC) by compression of the enlarged uterus in the third trimester. In this way, it is considered that it may reduce the amount of returning blood and cause hypotension. The incidence of this condition, called Supine Hypotension Syndrome, was reported to be 8%-10% (1-3). Spinal anesthesia, decreased sympathetic tonus, decreased systemic vascular resistance, and vasodilation may also cause hypotension in the patient (4).

It was considered that if the uterus is tilted, the pressure on the IVC would be removed, increasing the return, blood volume and cardiac output, improving the fetus, blood supply and oxygen supply (5). However, studies that were conducted so far have not proven significant differences and there is no routine standard practice (6-8). Here, 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., References

1. Howard BK, Goodson JH, Mengert WF. Supine hypotensive syndrome in late pregnancy. Obstet Gynecol. 1953;1:371-377.
2. Kinsella SM, Lohmann G. Supine hypotensive syndrome. Obstet Gynecol. 1994;83:774-788.
3. Rees GA, Willis BA. Resuscitation in late pregnancy. Anaesthesia. 1988;43:347-349.
4. Dyer RA, Reed AR, van Dyk D, et al. Hemodynamic effects of ephedrine, phenylephrine, and the coadministration of phenylephrine with oxytocin during spinal anesthesia for elective cesarean delivery. Anesthesiology. 2009;111:753-765.
5. Kinsella SM. Lateral tilt for pregnant women: why 15-degree? Anaesthesia. 2003;58:835-836.
6. Ellington C, Katz VL, Watson WJ, Spielman FJ. The effect of lateral tilt on maternal and fetal hemodynamic variables. Obstet Gynecol. 1991;77:201-203.
7. Bamber JH, Dresner M. Aortocaval compression in pregnancy: the effect of changing the degree and direction of lateral tilt on maternal cardiac output. Anesth Analg.

   2003;97:256-258.
8. Calvache JA, Mu.oz MF, Baron FJ. Hemodynamic effects of a right lumbar-pelvic wedge during spinal anesthesia for cesarean section. Int J Obstet Anesth. 2011;20:307-311.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: position
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aydin
country: Turkey
facility: Aydin Maternity and Child Health Hospital
Study officials:
affiliation: Aydin Maternity and Child Health Hospital
name: FERDİ GÜLAŞTI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.