Effect of Synthetic Oxytocin Administered During Labor on Breastfeedings

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951040
• Other study ID #: OXYTO-2011-BRSTF
• Status: Completed
• Phase: N/A
• First received: September 19, 2013
• Last updated: September 23, 2013
• Start date: February 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Hospital Materno-Infantil de Málaga
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: September 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breastfeeding

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Materno-Infantil de Málaga

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	use of breast-feeding	both, alone and combined with bottle feeding	21 months. From March 2011 to december 2012	No
Secondary	duration of breastfeeding	Number of months	21 months. From March 2011 to december 2012	No