Effect of Synthetic Oxytocin Administered During Labor on Breastfeedings

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

346 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breastfeeding

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Oxytocin, breastfeeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oxytocin

Oxytocin was administered during labor

No interventions assigned to this group

No Oxytocin

Oxytocine was not administered during labor

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

\-

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ernesto González Mesa

PHD Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ERNESTO GONZÁLEZ-MESA, PHD

Role: PRINCIPAL_INVESTIGATOR

Hospital Materno-Infantil de Málaga

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 24289796 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OXYTO-2011-BRSTF

Identifier Type: -

Identifier Source: org_study_id