Recurrent Pregnancy Loss Clinical Trial
Official title:
Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients With Unexplained Recurrent Pregnancy Loss
compare uterine artery blood flow before and after the administration of Isosorbide mononitrate as a nitric oxide donor during mid secretory phase of menstrual cycle for patients with unexplained recurrent pregnancy loss.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | September 2022 |
Est. primary completion date | August 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility | Inclusion Criteria: - Women age: 20-35 years. History of recurrent abortion (two or more successive spontaneous abortions) with : - Normal HSG or hysteroscopy - Normal serum PRL, - Normal thyroid function, - Normal HbA1c, - Normal pelvic ultrasound - Negative tests for antiphospholipid antibody syndrome (ACL, Lupus anticoagulant and anti B2 glycoprotein 1) Non pregnant state. Regular menstrual cycles for the previous three months before the study. No hormonal contraception or intrauterine devices. Not on any vasodilator drugs. Exclusion Criteria: Age less or more than 20-35. Nulligravidae or nullipara. Infertile women. Induced abortion. Systemic diseases that might affect the hemodynamic indices as thrombocytopenia and thyrotoxicosis. Cases with uterine anomalies, uterine myomas, polypi and adnexal masses. History of oophorectomy. History of consanguinity. Family history of chromosomal abnormality as Down syndrome and Turner syndrome. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Al-Azhar University |
Dimitriadis E, Menkhorst E, Saito S, Kutteh WH, Brosens JJ. Recurrent pregnancy loss. Nat Rev Dis Primers. 2020 Dec 10;6(1):98. doi: 10.1038/s41572-020-00228-z. Review. — View Citation
El Hachem H, Crepaux V, May-Panloup P, Descamps P, Legendre G, Bouet PE. Recurrent pregnancy loss: current perspectives. Int J Womens Health. 2017 May 17;9:331-345. doi: 10.2147/IJWH.S100817. eCollection 2017. Review. — View Citation
Mansour GM, Hussein SH, Abd El Hady RM, Mohammed HF, Abd El Gawad MM, Abou Gabal AI, Al-Awadhy RM, El Saied M. Uterine artery flow velocity waveform (FVW) type and subednometrial vascularity in recurrent pregnancy loss. J Matern Fetal Neonatal Med. 2020 Feb;33(4):527-532. doi: 10.1080/14767058.2018.1495190. Epub 2018 Aug 6. — View Citation
Taylor TJ, Quinton AE, de Vries BS, Hyett JA. First-trimester ultrasound features associated with subsequent miscarriage: A prospective study. Aust N Z J Obstet Gynaecol. 2019 Oct;59(5):641-648. doi: 10.1111/ajo.12944. Epub 2019 Feb 6. — View Citation
Yang W, Wu Z, Yu M, Peng X, Lu W, Feng W, Kang X. Characteristics of midluteal phase uterine artery hemodynamics in patients with recurrent pregnancy loss. J Obstet Gynaecol Res. 2019 Jul;45(7):1230-1235. doi: 10.1111/jog.13944. Epub 2019 Apr 11. — View Citation
Zhao Y, Vanhoutte PM, Leung SW. Vascular nitric oxide: Beyond eNOS. J Pharmacol Sci. 2015 Oct;129(2):83-94. doi: 10.1016/j.jphs.2015.09.002. Epub 2015 Sep 28. Review. — View Citation
Zullino S, Buzzella F, Simoncini T. Nitric oxide and the biology of pregnancy. Vascul Pharmacol. 2018 Nov;110:71-74. doi: 10.1016/j.vph.2018.07.004. Epub 2018 Aug 1. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients with Unexplained Recurrent Pregnancy Loss | compare uterine artery blood flow before and after the administration of Isosorbide mononitrate as a nitric oxide donor during mid secretory phase of menstrual cycle for patients with unexplained recurrent pregnancy loss. | baseline |
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