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:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT00342667
Eligibility Criteria:
* INCLUSION CRITERIA:
Consecutive patients admitted with the diagnosis of preterm labor/contractions or PROM.
"Preterm labor/contractions" will be defined as:
1. gestational age: 20-36 weeks;
2. intact membranes; and
3. regular uterine contractions greater than or equal to 8 in 60 minutes.
Preterm PROM will be defined as:
1. gestational age 20-36 weeks; and
2. spontaneous rupture of membranes as diagnosed by sterile speculum examination confirming pooling of amniotic fluid in the vagina, a positive Nitrazine test result, and a positive ferning test result. In cases of suspected but unconfirmed preterm PROM, indigo carmin instillation will be performed. The vaginal leakage of indigo carmin will confirm the diagnosis in these cases.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
45 Years
Study:
NCT00342667
Study Brief:
Protocol Section:
NCT00342667