Serum Progesterone and Threatened Abortion During Lactation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 1 trial group
Group A: Lactating Pregnant Women (First Trimester)

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment in the first trimester until 14 weeks of gestation

Secondary outcomes

1

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.

Time frame
At enrollment during the first trimester of pregnancy
2

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.

Time frame
Up to 14 weeks of gestation
3

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.

Time frame
During the first trimester of pregnancy

Other outcomes

Locations

This trial has no 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: