Can treatment with nitric oxide donors improve pregnancy outcome in patients with history of unexplained recurrent early pregnancy loss?
- Conditions
- fetal medicinecomplications of pregnancyunexplained recurrent early pregnancy lossReproductive Health and Childbirth - Fetal medicine and complications of pregnancy
- Registration Number
- ACTRN12616001494426
- Lead Sponsor
- Banha University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 158
The study included 225 patients with the following inclusion criteria: 1- Nulliparous aged 18-30 years, house-wives and nonsmokers. 2- History of two consecutive failed clinical pregnancies from the same husband during the first trimester and confirmed by ultrasound. 3- Normal levels of lupus anticoagulant and anticardiolipin IgG and IgM on two or more occasions at least 12 weeks apart. 4- Normal uterine cavity and no pelvic pathology diagnosed by 3D/4D ultrasound. Hysterography, Sono-hysterography, hysteroscopy and laparoscopy was done in few suspicious cases. 5- Normal blood glucose and hemoglobin A1c levels. 6- Normal serum TSH, serum prolactin and mid luteal phase serum progesterone levels >10 ng/ml. 7- Cytogenetic study of the parents was done for 14 patients who had the third loss during the study and feature no balanced reciprocal translocations.
Exclusion criteria include patients with cardiac disease, hypertension, sensitivity to NO donors and cases of interim ectopic or molar pregnancy or blighted ovum.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method