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 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT02196103
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed to be pregnant with PROM at \>34 weeks. Rupture of membranes will be determine clinically and confirmed by positive Nitrazine test.
* Ruptured membranes have occurred in the last 24 hours prior to inclusion in the study.
* Found to have an unripe cervix in a speculum examination.
* Singleton pregnancy in a vertex presentation well applied to the cervix and absence of significant and regular uterine contractions (3-5/10 Min)
* Previous on cesarian section.
* Willingness to comply with the protocol for the duration of the study.
* Have signed an informed consent.
Exclusion Criteria: Patients having any of the following conditions:
* Any contraindication for the vaginal delivery (i.e. placenta previa, non vertex presentation).
* Regular uterine contractions (3-5/10 min).
* Diagnosis of rupture membranes was made over 24 hours prior the study inclusion.
* Evidence of chorio-amnionitis (T 37.6 celsious Degree with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC\>/=20,000)
* Suspected placental abruption or presence of a significant hemorrhage.
* Non-reassuring fetal status (as determined by fetal heart rate monitoring and/or bio-physical profile) necessitating immediate intervention.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02196103
Study Brief:
Protocol Section:
NCT02196103