Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Synthetic Oxytocin Administered During Labor on Breastfeedings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01951040
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : September 26, 2013
Sponsor:
Information provided by (Responsible Party):
Ernesto González Mesa, Hospital Materno-Infantil de Málaga

Brief Summary:
This study was designed as a retrospective cohort study where patients given synthetic oxytocin during labor induction were considered as the exposed cohort, and patients not given oxytocin formed the non-exposed cohort. Four hundred of the 7465 children born at our maternity during 2006 were randomly selected. Information about breast-feeding was available for 316 of these children. Eventual confounding or adjustment factors were analyzed using stratified and multivariate analysis (logistic regression

Condition or disease
Breastfeeding

Detailed Description:

Study population consisted of children born in our center (Hospital Materno-Infantil in Malaga) during 2006. Our hospital is a tertiary center of the Spanish national health system where were born 7465 children, representing 41.2% of all babies born in our province, from 7246 deliveries during that year 21. Random sample size was estimated at 400, with a 95% confidence levels and a 20% power, considering an expected RR of 0.82 22, a ratio between exposed and unexposed groups of 1.5, and a 20% loss. The sample selection was done by random sampling with the SPSS random number generator.

Once approval was obtained from the ethics and research committee of the hospital, recruitment and monitoring of selected cases was started during 2011. Data were collected by review of clinical records and interviews with the mothers (particularly to record breast-feeding type and duration). Patients were referred to the hospital for a semi-structured interview in which data were collected for type and duration of feeding. Clinical records were used as information sources for obstetric variables. Both the interviews and the review of medical records were blinded and conducted by the study authors in different days

Layout table for study information
Study Type : Observational
Actual Enrollment : 346 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effect of Oxytocin Administered During Labor on the Onset and Duration of Breastfeeding: A Retrospective Cohort Study.
Study Start Date : February 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
Drug Information available for: Oxytocin

Group/Cohort
Oxytocin
Oxytocin was administered during labor
No Oxytocin
Oxytocine was not administered during labor



Primary Outcome Measures :
  1. use of breast-feeding [ Time Frame: 21 months. From March 2011 to december 2012 ]
    both, alone and combined with bottle feeding


Secondary Outcome Measures :
  1. duration of breastfeeding [ Time Frame: 21 months. From March 2011 to december 2012 ]
    Number of months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study population consisted of children born in our center (Hospital Materno-Infantil in Malaga) during 2006. Our hospital is a tertiary center of the Spanish national health system where were born 7465 children, representing 41.2% of all babies born in our province, from 7246 deliveries during that year
Criteria

Inclusion Criteria:

  • children born in our center (Hospital Materno-Infantil in Malaga) during 2006

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951040


Sponsors and Collaborators
Hospital Materno-Infantil de Málaga
Investigators
Layout table for investigator information
Principal Investigator: ERNESTO GONZÁLEZ-MESA, PHD Hospital Materno-Infantil de Málaga

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ernesto González Mesa, PHD Obstetrics and Gynecology, Hospital Materno-Infantil de Málaga
ClinicalTrials.gov Identifier: NCT01951040    
Other Study ID Numbers: OXYTO-2011-BRSTF
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013
Keywords provided by Ernesto González Mesa, Hospital Materno-Infantil de Málaga:
Oxytocin, breastfeeding
Additional relevant MeSH terms:
Layout table for MeSH terms
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs