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Completed

NCT Number: NCT01951040

Effect of Synthetic Oxytocin Administered During Labor on Breastfeedings

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

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Key information

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. use of breast-feeding

    Time frame: 21 months. From March 2011 to december 2012

    both, alone and combined with bottle feeding

Secondary outcomes

  1. duration of breastfeeding

    Time frame: 21 months. From March 2011 to december 2012

    Number of months

Sponsors and collaborators

Lead sponsor

Hospital Materno-Infantil de Málaga

Other

Registry information

Official study title

Effect of Oxytocin Administered During Labor on the Onset and Duration of Breastfeeding: A Retrospective Cohort Study.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2013
Registry last updated
Sep 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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