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NCT Number: NCT07357922

Serum Progesterone and Threatened Abortion During Lactation

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

About this study

This study is designed to investigate the relationship between maternal serum progesterone levels and threatened abortion in women who conceive during the lactation period. The primary objective is to evaluate first-trimester serum progesterone concentrations in lactating pregnant women and to assess their role in the etiology and clinical course of threatened abortion.

Threatened abortion is characterized by vaginal bleeding during the first trimester of pregnancy and is associated with an increased risk of early pregnancy loss. Progesterone plays a critical role in the maintenance of early pregnancy by supporting endometrial receptivity, suppressing uterine contractility, and modulating maternal immune tolerance. Previous studies have demonstrated that serum progesterone levels tend to be lower in pregnancies complicated by threatened abortion compared to uncomplicated pregnancies, and that reduced progesterone concentrations may be predictive of subsequent miscarriage.

Lactation is associated with distinct hormonal changes, primarily mediated by elevated prolactin levels, which suppress ovulation and result in progesterone levels comparable to those observed during the follicular phase of the menstrual cycle. Although progesterone levels increase following conception, the hormonal milieu during lactation may influence progesterone production and regulation in early pregnancy. However, normal reference ranges for serum progesterone levels in lactating pregnant women have not been clearly established, and data regarding their association with threatened abortion remain limited.

In this study, pregnant women who conceive during the lactation period will be enrolled. Maternal serum progesterone levels will be measured during the first trimester, and participants will be evaluated for the presence or absence of threatened abortion, defined as first-trimester vaginal bleeding with a viable intrauterine pregnancy. Clinical, obstetric, and demographic data will be recorded to allow assessment of potential confounding factors.

By examining the relationship between serum progesterone levels and threatened abortion in lactating pregnancies, this study aims to provide new insights into the hormonal mechanisms underlying early pregnancy complications. The findings may contribute to improved risk stratification, early diagnosis, and management strategies for threatened abortion in this specific population. Additionally, the study seeks to expand the limited body of literature on lactation-associated hormonal changes during early pregnancy and their clinical implications.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female participants aged 18 to 50 years.
  • Pregnant women who conceived during the lactation period.
  • Singleton pregnancy.
  • First-trimester pregnancy.
  • Availability of first-trimester serum progesterone measurement obtained as part of routine antenatal care.
  • Ongoing follow-up at the participating hospitals.

Exclusion criteria

  • Age under 18 years or over 50 years.
  • Multiple pregnancies.
  • Known chronic medical diseases.
  • Use of progesterone supplementation before serum progesterone measurement.
  • Missing or incomplete clinical or laboratory data.

Treatment and study plan

Primary outcomes

  1. Incidence of Threatened Abortion in Lactating Pregnant Women

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

    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

  1. First-Trimester Serum Progesterone Levels

    Time frame: At enrollment during the first trimester of pregnancy

    Maternal serum progesterone levels measured during the first trimester of pregnancy will be recorded and compared between women with and without threatened abortion.

  2. Early Pregnancy Loss

    Time frame: Up to 14 weeks of gestation

    The occurrence of pregnancy loss before 14 weeks of gestation will be recorded and evaluated in relation to first-trimester serum progesterone levels.

  3. Serum Progesterone Cut-off Value for Predicting Threatened Abortion

    Time frame: During the first trimester of pregnancy

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Burak D Aydoğdu, M.D.

CONTACT

[email protected]

+90 539 618 2228

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

Association Between Maternal Serum Progesterone Levels and Threatened Abortion in Lactating Pregnant Women

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 22, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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