MiscarriageNCT05461963
The Relationship Between Breastfeeding During Early Pregnancy and Miscarriage
An observational study of Miscarriage and Breast Feeding, run by Siirt University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Miscarriage, Breast Feeding
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2022to 1 Jan 2023
- 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 18 years and older
- Women only
- Adult, Older adult
Study population: Pregnant women over the age of 18 who are in the first trimester of pregnancy and continue to breastfeed
Who may be able to join
- being breastfeeding
- being at the 1.st trimester of pregnancy
Who cannot join
- history of inherited thrombophilia
- history of uterine anomaly
- history of trauma
- history of genetic anomaly
- history of habitual abortus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Miscarriage, Breast Feeding
- Medical subject headings
- Abortion, Spontaneous, 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 |
|---|---|---|
| breastfeeding pregnants( n:76) | pregnants in early weeks of pregnancy who practice breastfeeding | |
| control group ( n:76) | pregnants in early weeks of pregnancy who not practice breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miscarriage, ratio in breastfeeding pregnant women
Miscarriage is the spontaneous loss of a pregnancy before the 20th week,
Measured: From the 6th week of pregnancy to the 20th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start26 Jun 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MiscarriageStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siirt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serif Aksin, Siirt University
- Investigators
- Şerif Aksin, Study director, Siirt University Medical Faculty Obstetrics and Gynecology Departmant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461963
- Sponsor's protocol ID
- SiirtUN
- Status last verified
- Jan 2023
- First submitted
- 26 Jun 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31524957Lopez-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.
PubMed 28642112Ayrim 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.
PubMed 24160359
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding and Miscarriage Relationship
- ClinicalTrials.gov ID
- NCT05461963
- Acronym / sponsor ID
- SiirtUN
- Conditions
- Miscarriage, Breast Feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Siirt UniversityUniversity, hospital or other
- Study start
- 26 Jun 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 18 Jul 2022 (actual)
- 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breastfeeding pregnants( n:76) | – | –pregnants in early weeks of pregnancy who practice breastfeeding |
| control group ( n:76) | – | –pregnants in early weeks of pregnancy who not practice breastfeeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Pregnant women over the age of 18 who are in the first trimester of pregnancy and continue to breastfeed
Key inclusion criteria (2 listed)
- being breastfeeding
- being at the 1.st trimester of pregnancy
Key exclusion criteria (5 listed)
- history of inherited thrombophilia
- history of uterine anomaly
- history of trauma
- history of genetic anomaly
- history of habitual abortus
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
Miscarriage, ratio in breastfeeding pregnant women
Time frame: From the 6th week of pregnancy to the 20th week.
Miscarriage is the spontaneous loss of a pregnancy before the 20th week,
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 4 Jan 2023.
- Background: PubMed 31524957Molitoris 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.
- Background: PubMed 28642112Lopez-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.
- Background: PubMed 24160359Ayrim 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.
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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.
Şerif Aksin study director
Siirt University Medical Faculty Obstetrics and Gynecology Departmant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Miscarriage and Breast Feeding, run by Siirt University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Miscarriage, ratio in breastfeeding pregnant women (time frame: From the 6th week of pregnancy to the 20th week.). 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 NCT05461963, which also lists 3 linked publications.
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 4 Jan 2023.