Maternal-Fetal RelationslactationNCT02016937
Mother Lactation in The Postpartum Period
An observational study of Maternal-Fetal Relations, run by Duzce University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal-Fetal Relations
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Feb 2012
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- elective caesarian section
- normal vaginal delivery.
- between 18-40 years old
- risk of American society of anesthesiology grade-2
Who cannot join
- 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,
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Anesthesia Protocols on Mother Lactation in The Postpartum Period
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.
Read the 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.
- Conditions
- Maternal-Fetal Relations
- Keywords
- Anesthesia , lactation, birth
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group g | general anesthesia, n: 21 | |
| group S | spinal anesthesia, n: 21 | |
| group E | epidural anesthesia, n: 21 | |
| group V | vaginal birth, without anesthesia, n: 21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
onset time of lactation of mothers
By all patients onset time of lactation was recorded postoperatively
Measured: 24 h
Secondary outcomes (1)
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).
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maternal-Fetal RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yavuz demiraran, Duzce University
- Investigators
- Yavuz Demiraran, Study director, Duzce University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016937
- Sponsor's protocol ID
- leylakutlucan
- Other IDs
- Duzce University
- Acronym
- lactation
- Status last verified
- Dec 2013
- First submitted
- 4 Dec 2013
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15321436Baumgarder 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.
PubMed 12583645Uvnas-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.
PubMed 2244461
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Anesthesia Protocols on Mother Lactation in The Postpartum Period
- ClinicalTrials.gov ID
- NCT02016937
- Acronym / sponsor ID
- lactation / leylakutlucan
- Conditions
- Maternal-Fetal Relations
- Keywords
- Anesthesia , lactation, birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group g | – | –general anesthesia, n: 21 |
| group S | – | –spinal anesthesia, n: 21 |
| group E | – | –epidural anesthesia, n: 21 |
| group V | – | –vaginal birth, without anesthesia, n: 21 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- elective caesarian section
- normal vaginal delivery.
- between 18-40 years old
- risk of American society of anesthesiology grade-2
Key exclusion criteria (25 listed)
- Non-elective cases, plural pregnancies,
- Preterm pregnancies,
- Fetal anomalies,
- Retardation of fetal development,
- Newborns with birthweight under 2500 grams,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
onset time of lactation of mothers
Time frame: 24 h
By all patients onset time of lactation was recorded postoperatively
1 secondary outcome
hormon levels
Time frame: 24 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
- Results publication: PubMed 15321436Volmanen 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.
- Results publication: PubMed 12583645Baumgarder 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.
- Results publication: PubMed 2244461Uvnas-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.
- http://www.tip.duzce.edu.tr/Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yavuz Demiraran study director
Duzce University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal-Fetal Relations, run by Duzce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
onset time of lactation of mothers (time frame: 24 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02016937, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2013.