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

Threatened Abortion Clinical Trial

— CLCA125  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02420769
• Other study ID #: Beni-Suef 9
• Status: Completed
• Phase: N/A
• First received: April 5, 2015
• Last updated: December 5, 2017
• Start date: September 2014
• Est. completion date: May 2017

Study information

• Verified date: December 2017
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Threatened
• Threatened Abortion

Locations

Country	Name	City	State
Egypt	Beni-Suef University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Nesreen Abdel Fattah Abdullah Shehata	Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

Bast RC Jr, Feeney M, Lazarus H, Nadler LM, Colvin RB, Knapp RC. Reactivity of a monoclonal antibody with human ovarian carcinoma. J Clin Invest. 1981 Nov;68(5):1331-7. — View Citation

Chryssikopoulos A, Mantzavinos T, Kanakas N, Karagouni E, Dotsika E, Zourlas PA. Correlation of serum and follicular fluid concentrations of placental protein 14 and CA-125 in in vitro fertilization-embryo transfer patients. Fertil Steril. 1996 Oct;66(4):599-603. — View Citation

Gustavo Romero-Gutiérrez, Antonio Abraham Huebe-Martínez, Immer Amaral-Navarro, Armando Saú Ruiz-Treviño. Doppler Ultrasound Assessment in Women with Threatened Abortion, Clinical Medicine Research. Vol. 2, No. 3, 2013, pp.24-28. doi: 10.11648/j.cmr.20130

Jaffe R, Dorgan A, Abramowicz JS. Color Doppler imaging of the uteroplacental circulation in the first trimester: value in predicting pregnancy failure or complication. AJR Am J Roentgenol. 1995 May;164(5):1255-8. — View Citation

Kalinka J, Szekeres-Bartho J. The impact of dydrogesterone supplementation on hormonal profile and progesterone-induced blocking factor concentrations in women with threatened abortion. Am J Reprod Immunol. 2005 Apr;53(4):166-71. — View Citation

Kurjak A, Crvenkovic G, Salihagic A, Zalud I, Miljan M. The assessment of normal early pregnancy by transvaginal color Doppler ultrasonography. J Clin Ultrasound. 1993 Jan;21(1):3-8. — View Citation

Miller KA, Deaton JL, Pittaway DE. Evaluation of serum CA 125 concentrations as predictors of pregnancy with human in vitro fertilization. Fertil Steril. 1996 Jun;65(6):1184-9. — View Citation

Miranda S, Litwin S, Barrientos G, Szereday L, Chuluyan E, Bartho JS, Arck PC, Blois SM. Dendritic cells therapy confers a protective microenvironment in murine pregnancy. Scand J Immunol. 2006 Nov;64(5):493-9. — View Citation

Phocas I, Sarandakou A, Rizos D, Dimitriadou F, Mantzavinos T, Zourlas PA. Tumour-associated antigens, CEA, CA 125 and SCC in serum and follicular fluid of stimulated and unstimulated cycles. Eur J Obstet Gynecol Reprod Biol. 1994 Apr;54(2):131-6. — View Citation

Potdar N, Konje JC. The endocrinological basis of recurrent miscarriages. Curr Opin Obstet Gynecol. 2005 Aug;17(4):424-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viable fetus (According to WHO viable fetus >500 gm or > 20 weeks)	The investigators will assess how many patients in both groups reached viability of fetus. According to WHO viable fetus >500 gm or > 20 weeks.	from 20 weeks till 21 weeks gestation
Secondary	Resistance index of uterine artery and corpus luteum	Vaginal color doppler of uterine artery and corpus luteum for all pregnant patients in the study at first visit in ANC clinic .	from 8 weeks till 20 weeks
Secondary	serum CA125 and progesterone	serum CA125 and progesterone will be done for all pregnant patients at first visit in ANC clinic	from 8 weeks till 20 weeks gestation