Effect of Synthetic Oxytocin Administered During Labor on Breastfeedings

Sponsor

Hospital Materno-Infantil de Málaga (Other)

Overall Status

Completed

CT.gov ID

NCT01951040

Collaborator

(none)

346

Enrollment

Duration (Months)

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Design

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 :

Feb 1, 2011

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Oxytocin Oxytocin was administered during labor
No Oxytocin Oxytocine was not administered during labor

Outcome Measures

Primary Outcome Measures

use of breast-feeding [21 months. From March 2011 to december 2012]
both, alone and combined with bottle feeding

Secondary Outcome Measures

duration of breastfeeding [21 months. From March 2011 to december 2012]
Number of months

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospital Materno-Infantil de Málaga

Investigators

Principal Investigator: ERNESTO GONZÁLEZ-MESA, PHD, Hospital Materno-Infantil de Málaga

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Sep 26, 2013

Last Update Posted:

Sep 26, 2013

Last Verified:

Sep 1, 2013

Keywords provided by Ernesto González Mesa, PHD Obstetrics and Gynecology, Hospital Materno-Infantil de Málaga

Oxytocin, breastfeeding

Study Results

No Results Posted as of Sep 26, 2013