- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05461963
The Relationship Between Breastfeeding During Early Pregnancy and Miscarriage
January 1, 2023 updated by: Serif Aksin, Siirt University
Breastfeeding and Miscarriage Relationship
Breastfeeding provides various health and psychological benefits to mothers and their babies.
It also acts as an effective method of natural contraception when applied strictly for up to six months after birth.
Studies show that breastfeeding times are getting longer in the USA and more babies are breastfed for more than 12 months compared to the past.
Recent research shows that 57% of US infants are breastfed until at least six months of age, and more than a third continue to be breastfed for up to 12 months.
Prolonged breastfeeding durations increase the prevalence of breastfeeding during pregnancy, especially with the shortening of the intervals between pregnancies.
Breastfeeding during pregnancy is a relatively common practice in many parts of the world.
According to the data of studies conducted in low- and middle-income countries, it has been determined that 35% of the last born babies continue to be breastfed in the next pregnancy of their mothers.
It has also been shown that the prevalence of breastfeeding during pregnancy in low-income countries is between 15% and 50%.
Few research has been done on the relationship between breastfeeding during pregnancy and maternal, infant, or pregnancy outcomes.
Some studies have suggested that hormonal mechanisms in pregnancy may link breastfeeding during pregnancy and abortion.
When babies stimulate the nipple and areola during sucking, they trigger the release of oxytocin in the mother, causing a series of reactions that push the milk towards the nipple.
We know that the prevalence of short and long breastfeeding intervals in pregnancy is high in our country.
Therefore, in this study, we are planning to investigate whether there is a relationship between breastfeeding during pregnancy and miscarriage based on this information.
Study Overview
Status
Completed
Conditions
Detailed Description
Our aim in this study is to investigate whether breastfeeding during pregnancy increases the risk of abortion and to determine whether there is a relationship between them.
For this purpose, approximately 76 pregnant women who were pregnant and continuing to breastfeed in Siirt Training and Research Hospital between June 2022 and December 2022 will be included in the study.
The same number (n:76) non-breastfeeding pregnant control group will be included in the study.
Age, gestational week, pregnancy history (gravida, parity, abortion, missed, ectopic),breastfeeding time in previous pregnancies, bleeding, daily breastfeeding frequency and medical history of the pregnant will be recorded.
In the light of the information obtained in this way, we plan to determine whether there is a relationship between breastfeeding during pregnancy and abortion.
Study Type
Observational
Enrollment (Actual)
76
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Siirt, Turkey, 56000
- Siirt Üniversity Medical Faculty
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Pregnant women over the age of 18 who are in the first trimester of pregnancy and continue to breastfeed
Description
Inclusion Criteria:
- being breastfeeding
- being at the 1.st trimester of pregnancy
Exclusion Criteria:
- history of inherited thrombophilia
- history of uterine anomaly
- history of trauma
- history of genetic anomaly
- history of habitual abortus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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breastfeeding pregnants( n:76)
pregnants in early weeks of pregnancy who practice breastfeeding
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control group ( n:76)
pregnants in early weeks of pregnancy who not practice breastfeeding
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Miscarriage, ratio in breastfeeding pregnant women
Time Frame: From the 6th week of pregnancy to the 20th week.
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Miscarriage is the spontaneous loss of a pregnancy before the 20th week,
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From the 6th week of pregnancy to the 20th week.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Şerif Aksin, Siirt University Medical Faculty Obstetrics and Gynecology Departmant
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Molitoris J. Breast-feeding During Pregnancy and the Risk of Miscarriage. Perspect Sex Reprod Health. 2019 Sep;51(3):153-163. doi: 10.1363/psrh.12120. Epub 2019 Sep 16.
- Lopez-Fernandez G, Barrios M, Goberna-Tricas J, Gomez-Benito J. Breastfeeding during pregnancy: A systematic review. Women Birth. 2017 Dec;30(6):e292-e300. doi: 10.1016/j.wombi.2017.05.008. Epub 2017 Jun 19.
- Ayrim A, Gunduz S, Akcal B, Kafali H. Breastfeeding throughout pregnancy in Turkish women. Breastfeed Med. 2014 Apr;9(3):157-60. doi: 10.1089/bfm.2013.0086. Epub 2013 Oct 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 26, 2022
Primary Completion (Actual)
January 1, 2023
Study Completion (Actual)
January 1, 2023
Study Registration Dates
First Submitted
June 26, 2022
First Submitted That Met QC Criteria
July 14, 2022
First Posted (Actual)
July 18, 2022
Study Record Updates
Last Update Posted (Estimate)
January 4, 2023
Last Update Submitted That Met QC Criteria
January 1, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SiirtUN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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