MedDataX Logo

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

NCT ID: NCT02420769

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Threatened Abortion

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

CA 125 Progesterone Doppler Corpus Luteum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Threatened abortion

Pregnant patients \> 8 weeks gestation coming to the ANC clinic with mild vaginal bleeding but healthy viable intrauterine pregnancy. Vaginal color doppler for uterine artery and corpus luteum together with serum progesterone and CA125 will be assessed.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beni-Suef University

OTHER

Sponsor Role collaborator

Nesreen Abdel Fattah Abdullah Shehata

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nesreen Abdel Fattah Abdullah Shehata

Assisstant professor of Obstetrics and Gynecology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nesreen A Shehata, MD

Role: PRINCIPAL_INVESTIGATOR

Beni-Suef University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beni-Suef University

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1002/jcu.1870210103.

Reference Type BACKGROUND
PMID: 8478442 (View on PubMed)

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. doi: 10.2214/ajr.164.5.7717242.

Reference Type BACKGROUND
PMID: 7717242 (View on PubMed)

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. doi: 10.1111/j.1600-0897.2005.00261.x.

Reference Type BACKGROUND
PMID: 15760377 (View on PubMed)

Potdar N, Konje JC. The endocrinological basis of recurrent miscarriages. Curr Opin Obstet Gynecol. 2005 Aug;17(4):424-8. doi: 10.1097/01.gco.0000175363.20094.bd.

Reference Type BACKGROUND
PMID: 15976551 (View on PubMed)

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. doi: 10.1111/j.1365-3083.2006.01841.x.

Reference Type BACKGROUND
PMID: 17032241 (View on PubMed)

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. doi: 10.1172/jci110380.

Reference Type BACKGROUND
PMID: 7028788 (View on PubMed)

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. doi: 10.1016/0028-2243(94)90252-6.

Reference Type BACKGROUND
PMID: 8070597 (View on PubMed)

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. doi: 10.1016/s0015-0282(16)58336-8.

Reference Type BACKGROUND
PMID: 8641495 (View on PubMed)

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. doi: 10.1016/s0015-0282(16)58574-4.

Reference Type BACKGROUND
PMID: 8816623 (View on PubMed)

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.20130203.11

Reference Type RESULT

Shehata NAA, Ali HAA, Hassan AEGMA, Katta MA, Ali ASF. Doppler and biochemical assessment for the prediction of early pregnancy outcome in patients experiencing threatened spontaneous abortion. Int J Gynaecol Obstet. 2018 Nov;143(2):150-155. doi: 10.1002/ijgo.12631. Epub 2018 Aug 31.

Reference Type DERIVED
PMID: 30058068 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Beni-Suef 9

Identifier Type: -

Identifier Source: org_study_id