NCT05461963

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 26, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 26, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

June 26, 2022

Last Update Submit

January 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Miscarriage, ratio in breastfeeding pregnant women

    Miscarriage is the spontaneous loss of a pregnancy before the 20th week,

    From the 6th week of pregnancy to the 20th week.

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women over the age of 18 who are in the first trimester of pregnancy and continue to breastfeed

You may qualify if:

  • being breastfeeding
  • being at the 1.st trimester of pregnancy

You may not qualify if:

  • history of inherited thrombophilia
  • history of uterine anomaly
  • history of trauma
  • history of genetic anomaly
  • history of habitual abortus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siirt Üniversity Medical Faculty

Siirt, 56000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 31524957BACKGROUND
  • 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.

    PMID: 28642112BACKGROUND
  • 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.

    PMID: 24160359BACKGROUND

MeSH Terms

Conditions

Abortion, SpontaneousBreast Feeding

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Study Officials

  • Şerif Aksin

    Siirt University Medical Faculty Obstetrics and Gynecology Departmant

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 26, 2022

First Posted

July 18, 2022

Study Start

June 26, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations