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 @ 5:51 PM
Ignite Modification Date:
2025-12-24 @ 5:51 PM
NCT ID:
NCT05622968
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 year old
* Singleton pregnancy
* Cephalic presentation
* Multiparous women in their 2nd to 5th pregnancy (Para 1 to 4)
* Gestational age between 37+0 and 41+0 weeks.
* No previous uterine surgery (lower segment caesarean section, upper segment caesarean section, myomectomy
* Resides within 30 minutes drive from Hospital Kemaman
* Has access to a telephone
* Has reliable transportation (i.e. able to get to the hospital immediately without the need of ambulance)
* Acceptance of participation by the signing of a written consent.
Exclusion Criteria:
* Pregnancy with non-cephalic presentation
* Prior cesarean delivery
* Gestational hypertension or preeclampsia on 2 or more medications
* Diabetes in pregnancy on high dose medication(s); insulin of more than 60 units per day or combination of insulin and oral hypoglycemic agent
* Low lying placenta or placenta praevia
* Rupture of amniotic membrane
* Primiparae and grandmultiparae (para 5 or more)
* Multiple pregnancy
* Fetal death
* Fetal anomalies: defined as the presence of a major fetal anomaly of any organ system
* Fetal growth restriction: defined as an ultrasound derived estimated fetal weight less than the 10th percentile for gestational age
* Suspected macrosomia: defined as an ultrasound derived estimated fetal weight of more than 90th centile for gestational age
* Oligohydramnios: ultrasound measured amniotic fluid index (AFI) less than the 10th percentile for gestational age
* Polyhydramnios: defined as an AFI of 24 cm or greater or a single deepest vertical pocket of 8 cm or greater
* Latex allergy
* Contraindication to induction of labor
* Evidence of active phase of labor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05622968
Study Brief:
Protocol Section:
NCT05622968