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Threatened AbortionCLCA125NCT02420769

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

An observational study of Threatened Abortion, run by Nesreen Abdel Fattah Abdullah Shehata at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
Threatened Abortion
How many people
100 participants
Where
1 siteEgypt
Study dates
Sep 2014to May 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Pregnant females >8 weeks but < 20 weeks gestation. They are presenting with a complaint of threatened abortion to our outpatient ANC clinic.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Beni-Suef University

    Cairo, 018

Other trials in Egypt

About this study

Official title: Color Doppler of CL and Uterine Artery With Serum Progesterone 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.

Read the detailed 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 .

Keywords
CA 125, Progesterone, Doppler, Corpus Luteum
Medical subject headings
Abortion, Threatened

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02420769
Study groupRoleWhat they receive
Threatened abortionPregnant 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: from 20 weeks till 21 weeks gestation

Secondary outcomes (2)

  1. 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 .

    Measured: from 8 weeks till 20 weeks

  2. serum CA125 and progesterone

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

    Measured: from 8 weeks till 20 weeks gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02420769
Sponsor's protocol ID
Beni-Suef 9
Acronym
CLCA125
Status last verified
Dec 2017
First submitted
5 Apr 2015
Last updated
7 Dec 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 8478442

  • 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.

    PubMed 7717242

  • 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.

    PubMed 15760377

  • 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.

    PubMed 15976551

  • 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.

    PubMed 17032241

  • 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.

    PubMed 7028788

  • 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.

    PubMed 8070597

  • 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.

    PubMed 8641495

  • 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.

    PubMed 8816623

  • 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

  • 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.

    PubMed 30058068

Questions about this trial

What is this clinical trial studying?

An observational study of Threatened Abortion, run by Nesreen Abdel Fattah Abdullah Shehata at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Viable fetus (According to WHO viable fetus >500 gm or > 20 weeks) (time frame: from 20 weeks till 21 weeks gestation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02420769, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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