About this trial
This study aims to evaluate the effect of first-trimester maternal serum progesterone levels on threatened abortion in women who conceive during the lactation period. Serum progesterone concentrations will be measured in lactating pregnant women during the first trimester, and their association with the etiology of threatened abortion will be analyzed.
Threatened abortion is defined as vaginal bleeding occurring in the first trimester of pregnancy and represents a risk for early pregnancy loss. Previous studies have shown that serum progesterone levels may be lower in cases of threatened abortion compared to healthy pregnancies and play an essential role in predicting miscarriage risk. Serum progesterone is therefore considered a useful biomarker for assessing pregnancy viability and prognosis.
During lactation, progesterone levels may vary depending on breastfeeding duration and maternal hormonal status, and generally remain low, similar to follicular-phase levels in non-pregnant women. However, normal reference values during lactation are not well established. This study aims to contribute new data to the limited literature on the relationship between lactation, serum progesterone levels, and threatened abortion, and to provide insights that may help improve early pregnancy loss prevention strategies.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female participants aged 18 to 50 years.
Pregnant women who conceived during the lactation period.
Singleton pregnancy.
First-trimester pregnancy.
Disqualifiers
Age under 18 years or over 50 years.
Multiple pregnancies.
Known chronic medical diseases.
Use of progesterone supplementation before serum progesterone measurement.
Trial population
The study population consists of lactating pregnant women aged 18 to 50 years who present for routine antenatal care during the first trimester of pregnancy at the participating obstetrics and gynecology clinics. Eligible participants include women who conceived while breastfeeding and have available first-trimester serum progesterone measurements. Participants will be prospectively followed to evaluate the occurrence of threatened abortion and early pregnancy outcomes.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Incidence of Threatened Abortion in Lactating Pregnant Women
The incidence of threatened abortion, defined as first-trimester vaginal bleeding with a viable intrauterine pregnancy, assessed by clinical evaluation and ultrasonographic confirmation.
Secondary outcomes
First-Trimester Serum Progesterone Levels
Maternal serum progesterone levels measured during the first trimester of pregnancy will be recorded and compared between women with and without threatened abortion.
Early Pregnancy Loss
The occurrence of pregnancy loss before 14 weeks of gestation will be recorded and evaluated in relation to first-trimester serum progesterone levels.
Serum Progesterone Cut-off Value for Predicting Threatened Abortion
The optimal first-trimester serum progesterone cut-off value for predicting threatened abortion in lactating pregnant women will be determined using receiver operating characteristic (ROC) curve analysis.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: