Corpus Luteum and Uterine Artery Doppler With Serum P and CA125 in Threatened Abortion

The purpose of this study is to determine whether assessing color doppler of corpus luteum and uterine artery is useful in predicting patients who will complete pregnancy. The investigators will add to this the usefulness of serum progesterone and CA125 in prediction.

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Key information

Conditions

Threatened Abortion Abortion, Threatened Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Beni-Suef University

Cairo, 018, Egypt

About this study

The introduction of Doppler ultrasound in obstetrics has allowed evaluating hemodynamic characteristics from the first trimester of pregnancy. For example, Kurjak et al.,in one of the first studies using transvaginal pulsed-wave Doppler ultrasound in early pregnancies, identified the uterine arteries in 100% of the patients. The flow blood of the corpus luteum was identified in 75% patients. The measures obtained by Doppler ultrasonography that may have prognostic value to the evolution of pregnancy include uteroplacental blood flow, also known as trophoblastic flow. Jaffe et al. reported that abnormal Doppler findings were associated with a significantly higher prevalence of complicated pregnancies, among women with abnormal Doppler findings, 43% ended in miscarriage, whereas among women with normal findings only 1.4% of women miscarried.Progesterone plays a crucial role in the maintenance of pregnancy. In the presence of sufficient progesterone levels during pregnancy, lymphocytes synthesize a mediator called progesterone induced blocking factor (PIBF), which is anti-abortive in mice . Besides inducing secretary changes in the endometrium and supporting early pregnancy, it modulates the maternal immune response to prevent fetal rejection and relaxes the uterine smooth muscles .CA-125, well-known as a tumor marker for epithelial ovarian cancer , is a high molecular weight glycoprotein that is produced not only by ovarian cancer, but also by nonovarian tumors, normal epithelia of the peritoneum, the endometrium, the fallopian tube, and the ovary. Because CA-125 is also produced by the endometrium, some authors suggest that CA-125 can be used as a marker for endometrial receptivity in patients undergoing IVF . Its role as a predictor for pregnancy outcome is controversial .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

patients with pregnancy between 8 to 20 weeks of gestation,
who were diagnosed with threatened abortion.

Exclusion criteria

patients with multiple pregnancies,
molar pregnancy,
ectopic pregnancy,
amenorrhea with different etiologies of pregnancy,
maternal history of systemic diseases and uterine anatomic abnormalities
patients who did not have their outcome data through week 20 of gestation due to relocation.

Treatment and study plan

Primary outcomes

Viable fetus (According to WHO viable fetus >500 gm or > 20 weeks)

Time frame: from 20 weeks till 21 weeks gestation

The investigators will assess how many patients in both groups reached viability of fetus. According to WHO viable fetus >500 gm or > 20 weeks.

Secondary outcomes

Resistance index of uterine artery and corpus luteum

Time frame: from 8 weeks till 20 weeks

Vaginal color doppler of uterine artery and corpus luteum for all pregnant patients in the study at first visit in ANC clinic .
serum CA125 and progesterone

Time frame: from 8 weeks till 20 weeks gestation

serum CA125 and progesterone will be done for all pregnant patients at first visit in ANC clinic

Sponsors and collaborators

Lead sponsor

Nesreen Abdel Fattah Abdullah Shehata

Other

Collaborators

Beni-Suef University

Registry information

Official study title

Color Doppler of CL and Uterine Artery With Serum Progesterone and CA125 in Threatened Abortion

Acronym: CLCA125

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Apr 20, 2015
Registry last updated: Dec 7, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed