Overview
Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions
Status:
Recruiting
Recruiting
Trial end date:
2022-06-30
2022-06-30
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
The purpose of this study is to specifically investigate whether oxytocin and mechanical dilation decreases the rate of cesarean section compared to misoprostol and mechanical dilation for pregnancies at risk of fetal compromisePhase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Thomas Jefferson UniversityTreatments:
Misoprostol
Oxytocin
Criteria
Inclusion Criteria:- • Age > 18 years old
- Singleton, or twins with demise of one
- Cephalic presentation
- Intact membranes
- Hypertension (chronic hypertension, gestational hypertension, pre-eclampsia
with/without severe features, superimposed preeclampsia with/without severe
features, eclampsia, HELLP)
- Oligohydramnios (AFI< 5cm and/or MVP <2cm)
- Fetal growth restriction (EFW or AC <10th percentile) with normal or abnormal
(elevated, absent, or reversed) Umbilical Artery Dopplers
- Abnormal antenatal fetal testing (NST, Biophysical profile, decreased fetal
movement) prompting induction of labor
- Suspected placental abruption
- Poorly controlled pre-gestational diabetes, defined as >50% abnormal glucose
values requiring increasing doses of anti-glycemic agents >34 weeks, or requiring
delivery
- Gestational Age > 22 weeks
- Bishop score < 6
Exclusion Criteria:
- • Prior cesarean delivery
- Allergy to misoprostol
- Allergy to oxytocin
- Allergy to silicone/latex
- Contraindication to vaginal delivery including placenta or vasa previa, Placenta
accreta/increta/percreta, prior uterine rupture, Prior myomectomy entering the
uterine cavity and necessitating cesarean delivery, active genital herpes,
transverse or oblique fetal lie, umbilical cord prolapse, or HIV viral load >1000
copies/mL