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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT02055794
Eligibility Criteria:
Inclusion Criteria:
* Women 18 years old - 45 years old
* Immediately post-vaginal birth, including forceps-assisted vaginal delivery, vacuum-assisted vaginal delivery
* \> 32 weeks gestation
* Second degree laceration from spontaneous tear or midline episiotomy
* Proficient in English
Exclusion Criteria:
* \<18 years old and \>45 years old
* Delivery by Cesarean
* 1st, 3rd or 4th degree lacerations
* Induction for intrauterine fetal demise or terminal fetal condition, or any instance where immediate status of the newborn is unknown
* Known allergy to cyanoacrylate or formaldehyde
* Systemic infections, uncontrolled diabetes (women with well-controlled pre-gestational or gestational diabetes will not be excluded)
* History of connective tissue disorders (e.g. Scleroderma, Ehlers Danlos)
* Chronic use of steroids
* Currently under treatment for cancer
* Previous radiation to the pelvis
* Any organ transplants
* History of neurological conditions including multiple sclerosis, stroke, Alzheimer's, or other dementias
* Not proficient in the English language
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02055794
Study Brief:
Protocol Section:
NCT02055794