Maternal-Fetal Relations Clinical Trial
— lactationOfficial title:
Effects of Different Anesthesia Protocols on Mother Lactation in The Postpartum Period
Verified date | December 2013 |
Source | Duzce University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Observational [Patient Registry] |
In our study we aimed to compare the lactation process by mothers who were undergoing elective Caesarian section under general anesthesia, spinal anesthesia, epidural anesthesia and normal vaginal birth.
Status | Completed |
Enrollment | 84 |
Est. completion date | February 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - elective caesarian section - normal vaginal delivery. - between 18-40 years old - risk of American society of anesthesiology grade-2 Exclusion criteria : - Non-elective cases, plural pregnancies, - Preterm pregnancies, - Fetal anomalies, - Retardation of fetal development, - Newborns with birthweight under 2500 grams, - Infants with risk of aspiration of meconium or amnios, - Pathologies affecting acid-base balance, - Diabetes mellitus, - Hypertension, - Antepartum hemorrhage, - COPD (chronic obstructive pulmonary disease), - Rhesus incompatibility, - Obstetric complications like congenital malformations, - History of malignant hypertermia, - Morbid obesity, opioid sensitivity, - Alcohol or drug addiction, - Diseases of coronary arteria, - Congestive heart failure, - Serious anemia, - History of liver or kidney diseases, - Hypovolemia, hypotension, - Systemic inflammatory response syndrome, - Sepsis, - History of allergic reactions to drugs used in the study, - History of drugs affecting lactation. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Turkey | Anesthesiology Department | Duzce |
Lead Sponsor | Collaborator |
---|---|
Duzce University |
Turkey,
Baumgarder DJ, Muehl P, Fischer M, Pribbenow B. Effect of labor epidural anesthesia on breast-feeding of healthy full-term newborns delivered vaginally. J Am Board Fam Pract. 2003 Jan-Feb;16(1):7-13. — View Citation
Uvnäs-Moberg K, Widström AM, Werner S, Matthiesen AS, Winberg J. Oxytocin and prolactin levels in breast-feeding women. Correlation with milk yield and duration of breast-feeding. Acta Obstet Gynecol Scand. 1990;69(4):301-6. — View Citation
Volmanen P, Valanne J, Alahuhta S. Breast-feeding problems after epidural analgesia for labour: a retrospective cohort study of pain, obstetrical procedures and breast-feeding practices. Int J Obstet Anesth. 2004 Jan;13(1):25-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Apgar scores | Neonate APGAR Scores 1st and 5th minutes were recorded | 5 min | Yes |
Primary | onset time of lactation of mothers | By all patients onset time of lactation was recorded postoperatively | 24 h | Yes |
Secondary | hormon levels | In all groups blood samples were taken at the 24th hour after delivery and oxytocin and prolactin levels were measured. Plasma of blood samples taken before and after delivery were stored at a temperature of -80°C. Prolactin levels were determined with chemiluminescense immunoassay technique Cobas e 601 (Roche® Diagnostics, Mannheim, Germany) using a commercial kit (Roche®). Oxytocin levels were determined with a commercial ELISA kit (Cusabio Biotech CO. Ltd). | 24 h | Yes |
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