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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT01773135
Eligibility Criteria:
Inclusion Criteria:
* Singleton pregnancy.
* Age between 17 - 35 years.
* Gestational age between 28 and 36 weeks.
* Diagnosis of threatened preterm labor is based on the American College of Obstetricians and Gynaecologists Guidelines (ACOG, 2003): Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation \> 1 and \< 4 cm, and/or Cervical effacement ≥ 80%.
Exclusion Criteria:
* Preterm rupture of membranes.
* Any uterine anomalies or cervical incompetence.
* Chronic illness such as chronic hypertension or kidney disease.
* Diabetes mellitus.
* Abruptio placenta.
* Preeclampsia and HELLP syndrome.
* Fetal anomalies.
* IUGR.
* Smoking.
* Clinical signs of intrauterine infection eg (uterine tenderness, foul vaginal discharge, maternal pyrexia ≥ 38°C and/or maternal leucocytosis).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
17 Years
Maximum Age:
35 Years
Study:
NCT01773135
Study Brief:
Protocol Section:
NCT01773135