Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT06011057
Eligibility Criteria:
Inclusion Criteria:
* All pregnant women in the age group (20-35) between 7 and 13 weeks gestation in which a singleton embryo with evident cardiac activity with sure last menstrual period (LMP) constant with 1st trimester documented ultrasound
* The included subjects will be divided into two groups:-
1. Group 1 (control) will consist of 50 pregnant women with uneventful pregnancies without any problem.
2. Group 2 (patients) will consist of 50 pregnant women with threatened miscarriage, of them.
Exclusion Criteria:
* Multiple pregnancies.
* Women having received hormonal treatment or progesterone supplements.
* Pregnancies with a difference of more than 7 days between last menstrual period (LMP) and crown- rump length.
* History of general medical disease e.g. diabetes, thyroid disease or antiphospholipid syndrome, Presence of local (gynecological) disease e.g. fibroid or adnexal masses verified by normal appearance of the uterus and ovaries by ultrasound.
* Presence of uterine malformations e.g. hypoplastic uterus or septate uterus diagnosed by history of recurrent miscarriage, hysterosalpingography or 3D ultrasound, Intake of natural or synthetic progesterone.
* Obesity.
* Ectopic pregnancy
* Vesicular mole
* Fetal demise by Ultrasound
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
35 Years
Study:
NCT06011057
Study Brief:
Protocol Section:
NCT06011057