NCT02016937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
Last Updated

December 20, 2013

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

December 4, 2013

Last Update Submit

December 16, 2013

Conditions

Keywords

Anesthesia , lactation, birth

Outcome Measures

Primary Outcomes (1)

  • onset time of lactation of mothers

    By all patients onset time of lactation was recorded postoperatively

    24 h

Secondary Outcomes (1)

  • hormon levels

    24 h

Other Outcomes (1)

  • Apgar scores

    5 min

Study Arms (4)

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

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • elective caesarian section
  • normal vaginal delivery.
  • between 18-40 years old
  • risk of American society of anesthesiology grade-2

You may not qualify if:

  • 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,
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology Department

Düzce, 81620, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Yavuz Demiraran

    Duzce University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 20, 2013

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

December 20, 2013

Record last verified: 2013-12

Locations