Clinical trial NCT02016937: Mother Lactation in The Postpartum Period
Official title: Effects of Different Anesthesia Protocols on Mother Lactation in The Postpartum Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal-Fetal Relations
Keywords: Anesthesia , lactation, birth
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 84 patients were included. 63 of them were undergoing elective caesarian section and 21 patients had normal vaginal delivery in the Clinic of Gynecology and Obstetrics. All patients were between 18-40 years old and with the risk of ASA II.

Brief summary: 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.

Detailed description: Patients were randomly divided into 4 groups: group G (general anesthesia for Caesarean section, n=21), group S (spinal anesthesia for Caesarean section, n=21), group E (epidural anesthesia for Caesarean section, n=21), group V (normal vaginal birth without anesthesia, n=21). Blood sample of 3 mililiters was taken from all patients 2,5 hours before procedure and oxytocin and prolactin levels in this blood samples were determined. No patient received premedication. Group G (general anesthesia for Caesarean section) received preoxygenation with 100% oxygen for 3-5 minutes before intubation. In order to let fetus minimally affected by the anesthetic agents, induction was performed after the disinfection and covering up of surgery area. Induction was performed with propofol (2 mg/ kg) and rocuronium (0,6 mg/kg). After onset of neuromuscular block, patients were intubated with compression maneuver of cricoid cartilage. Controlled ventilation was provided with anesthesia machine Datex Ohmeda S/5 Avance with tidal volume of 8-10 ml/kg, respiration frequency of 10-12 min. Anesthesia was maintained with oxygen (50%) , air (50%), sevoflurane of 1 MAC. When necessary rocuronium 0,15 mg/kg was administered. After delivery of the newborn, fentanyl 1-1,5 mcg/ kg was administered.

Patients in group S (spinal anesthesia for Caesarean section) received 750-1000 mL of 0,9% NaCI solution (10-15 mL/kg) as infusion in 20-30 minutes. Under strict aseptic precautions a 25G Quincke spinal needle was introduced into L3-L4 or L4-L5 intervertebral space in midline approach in sitting posture, and, after confirming free flow of CSF, predetermined 10-11 mg of drug solution (hypertonic bupivacaine 0,5%) was injected. We let the operation begin when sensory and motor blockade were verified. Oxygen of 100% (3 L. min) was administered throughout the operation via nasal cannula.

Patients in group E (epidural anesthesia for Caesarean section) received 750-1000 mL of 0,9% NaCI solution (10-15 mL/kg) as infusion in 20-30 minutes. We conducted epidural anesthesia with 18-gauge Tuohy needle at L3-L4 or L4-L5 epidural space by midline approach at sitting position. 3 -5 minutes after injection of 3 ml lidocaine as test-dose, when the patient has no sign of subarachnoid injection like prickling in lower extremities or of intravascular injection like nausea, vomiting, tachicardia, tinnitus, a 20-gauge epidural catheter was inserted to cephalad. We injected 10 ml of 0.5% bupivacaine via epidural catheter. We let the operation begin when sensory and motor blockade were verified. Oxygen of 100% (3 L. min) was administered throughout the operation via nasal cannula.

Patients in all 3 groups were monitorised in the operation room with a monitor of Datex-Ohmeda and electrocardiogram (ECG), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), peripheral oxygen saturation (SPO2) were recorded. Efedrin 5-10 mg and/or atropin 0,5 mg was administered when significant hypotension and bradicardia occurred. After delivery of the newborn 30 IU of oxytocin in a 1000cc solution of 0,9% NaCI was infused and if patient was not hypertensive, methylergonovine of 0,2 mg was administered intramuscular.

Patients in group V (spontaneous vaginal birth without anesthesia) were spectated by gynecologists in the Clinic of Gynecology and Obstetrics during the delivery. They received no anesthesia.

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). By all patients onset time of lactation was recorded.

Eligibility criteria: 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.

Primary outcomes:
measure: onset time of lactation of mothers
timeFrame: 24 h
Secondary outcomes:
measure: hormon levels
timeFrame: 24 h
Other outcomes:
measure: Apgar scores
timeFrame: 5 min
Locations:
city: Duzce
country: Turkey
facility: Anesthesiology Department
Study officials:
affiliation: Duzce University School of Medicine
name: Yavuz Demiraran
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/S0959-289X(03)00104-3.
citation: 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. doi: 10.3122/jabfm.16.1.7.
citation: Uvnas-Moberg K, Widstrom 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. doi: 10.3109/00016349009036151.