Prediction of Postdural Puncture Headache

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorAmasya University

About this trial

The primary objective of this study is to evaluate the effectiveness of inflammation index (pan-immune inflammation value, systemic immune inflammation index, and systemic inflammatory response index) values, calculated from routine pre- and post-operative blood test (hemogram) results of pregnant women undergoing cesarean section under spinal anesthesia, in predicting postdural puncture headache. Significant results will allow for the early identification of the population at risk of developing PPH and the implementation of preventive measures. The secondary objectives of the study are to evaluate the effects of factors such as demographic data (age, height, weight, and body mass index) obtained from patient records and the hospital information system, number of births, blood group, infant birth weight, smoking, previous history of postdural puncture headache (PPH), or headache in general, on the development of postdural puncture headache (PPH), to determine the frequency of PPH, and to identify the symptoms accompanying PPH.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

. Pregnant women who are of a cognitive level capable of giving informed consent

Pregnant women aged 18-45 who have undergone elective cesarean section

Term (37 weeks and above) pregnant women

Patients with an American Society of Anesthesiologists (ASA) physical status score of 2 (ASA II)

Disqualifiers

History of active infection or chronic inflammatory disease

History of steroid or immunomodulatory drug use

Presence of coagulopathy or hematological disorder

Presence of preeclampsia/HELLP syndrome

Trial population

Pregnant women undergoing cesarean section under spinal anesthesia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

260 Participants
are grouped into 2 trial groups
Group A: Patients with postdural puncture headache
Group B: Patients without postdural puncture headache

Trial outcomes

Primary outcomes

1

The predictive role of inflammation indices for postdural puncture headache.

* The correlation between the preoperative basal panimmune inflammation value, systemic immune-inflammation index, and systemic inflammatory response index values and the development of PPH will be statistically evaluated. * Sensitivity and specificity evaluation will be performed for basal panimmune inflammation value, systemic immune-inflammation index, and systemic inflammatory response index values in those who develop PPH.

Time frame
5 days

Secondary outcomes

1

PPH incidence

The incidence of PPH developing after postdural puncture will be investigated.

Time frame
5 days

Other outcomes

Sponsors and contacts

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