BreastfeedingNCT01951040
Effect of Synthetic Oxytocin Administered During Labor on Breastfeedings
An observational study of Breastfeeding, run by Hospital Materno-Infantil de Málaga.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breastfeeding
- How many people
- 346 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- children born in our center (Hospital Materno-Infantil in Malaga) during 2006
Who cannot join
- -
About this study
Official title: Effect of Oxytocin Administered During Labor on the Onset and Duration of Breastfeeding: A Retrospective Cohort Study.
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
Read the 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
- Conditions
- Breastfeeding
- Keywords
- Oxytocin, breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Oxytocin was administered during labor | |
| No Oxytocin | Oxytocine was not administered during labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
use of breast-feeding
both, alone and combined with bottle feeding
Measured: 21 months. From March 2011 to december 2012
Secondary outcomes (1)
duration of breastfeeding
Number of months
Measured: 21 months. From March 2011 to december 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startFeb 2011
- Primary completionJan 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Materno-Infantil de Málaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernesto González Mesa, Hospital Materno-Infantil de Málaga
- Investigators
- ERNESTO GONZÁLEZ-MESA, PHD, Principal investigator, Hospital Materno-Infantil de Málaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951040
- Sponsor's protocol ID
- OXYTO-2011-BRSTF
- Status last verified
- Sep 2013
- First submitted
- 19 Sep 2013
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24289796
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oxytocin Administered During Labor on the Onset and Duration of Breastfeeding: A Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT01951040
- Acronym / sponsor ID
- OXYTO-2011-BRSTF
- Conditions
- Breastfeeding
- Keywords
- Oxytocin, breastfeeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Hospital Materno-Infantil de MálagaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 26 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | – | –Oxytocin was administered during labor |
| No Oxytocin | – | –Oxytocine was not administered during labor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- children born in our center (Hospital Materno-Infantil in Malaga) during 2006
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
use of breast-feeding
Time frame: 21 months. From March 2011 to december 2012
both, alone and combined with bottle feeding
1 secondary outcome
duration of breastfeeding
Time frame: 21 months. From March 2011 to december 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
- Derived from this study: PubMed 24289796Garcia-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ERNESTO GONZÁLEZ-MESA, PHD principal investigator
Hospital Materno-Infantil de Málaga
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding, run by Hospital Materno-Infantil de Málaga.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
use of breast-feeding (time frame: 21 months. From March 2011 to december 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01951040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2013.