NCT01951040

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
346

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Typical duration for all trials

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

February 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2013

Completed
Last Updated

September 26, 2013

Status Verified

September 1, 2013

Enrollment Period

1.9 years

First QC Date

September 19, 2013

Last Update Submit

September 23, 2013

Conditions

Keywords

Oxytocin, breastfeeding

Outcome Measures

Primary Outcomes (1)

  • use of breast-feeding

    both, alone and combined with bottle feeding

    21 months. From March 2011 to december 2012

Secondary Outcomes (1)

  • duration of breastfeeding

    21 months. From March 2011 to december 2012

Study Arms (2)

Oxytocin

Oxytocin was administered during labor

No Oxytocin

Oxytocine was not administered during labor

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Garcia-Fortea P, Gonzalez-Mesa E, Blasco M, Cazorla O, Delgado-Rios M, Gonzalez-Valenzuela MJ. Oxytocin administered during labor and breast-feeding: a retrospective cohort study. J Matern Fetal Neonatal Med. 2014 Oct;27(15):1598-603. doi: 10.3109/14767058.2013.871255. Epub 2014 Jan 13.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • ERNESTO GONZÁLEZ-MESA, PHD

    Hospital Materno-Infantil de Málaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD Obstetrics and Gynecology

Study Record Dates

First Submitted

September 19, 2013

First Posted

September 26, 2013

Study Start

February 1, 2011

Primary Completion

January 1, 2013

Study Completion

September 1, 2013

Last Updated

September 26, 2013

Record last verified: 2013-09