Status:
COMPLETED
Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions
Lead Sponsor:
Thomas Jefferson University
Conditions:
Cesarean Section
Misoprostol
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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...
Detailed Description
This is a single center randomized control trial of two arms. Singleton, cephalic, high risk pregnancies will be randomized to either oxytocin with mechanical dilation versus misoprostol with mechanic...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
August 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04492072
Start Date
August 17 2020
End Date
May 26 2022
Last Update
June 14 2022
Active Locations (1)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107