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

NCT02420769 | Completed DMC

• 1 other identifier: Beni-Suef 9
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Threatened Abortion

Keywords

CA 125; Progesterone; Doppler; Corpus Luteum

Outcome Measures

Primary Outcomes (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.

  from 20 weeks till 21 weeks gestation

Secondary Outcomes (2)

• Resistance index of uterine artery and corpus luteum

  from 8 weeks till 20 weeks

• serum CA125 and progesterone

  from 8 weeks till 20 weeks gestation

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nesreen Abdel Fattah Abdullah Shehata: lead
• Beni-Suef University: collaborator

Study Sites (1)

Beni-Suef University

Cairo, 018, Egypt

Location

Related Publications (11)

• 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.

  PMID: 8478442 BACKGROUND

• 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.

  PMID: 7717242 BACKGROUND

• 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.

  PMID: 15760377 BACKGROUND

• 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.

  PMID: 15976551 BACKGROUND

• 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.

  PMID: 17032241 BACKGROUND

• 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.

  PMID: 7028788 BACKGROUND

• 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.

  PMID: 8070597 BACKGROUND

• 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.

  PMID: 8641495 BACKGROUND

• 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.

  PMID: 8816623 BACKGROUND

• 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

  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.

  PMID: 30058068 DERIVED

MeSH Terms

Conditions

Abortion, Threatened

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Nesreen A Shehata, MD

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assisstant professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 5, 2015
• First Posted: April 20, 2015
• Study Start: September 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: December 7, 2017

Record last verified: 2017-12

Locations

EG (1)