Cesarean Section, High Risk Pregnancy, Misoprostol, Oxytocin
Conditions
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 at risk of fetal compromise
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 mechanical dilation. In group A, receiving misoprostol with mechanical dilation, will serve as the control group. Group B, oxytocin with mechanical dilation, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.
Interventions
DRUGOxytocin
Intervention
DRUGMisoprostol
Control
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Cesarean Delivery | 48 hours | Total rate of cesarean delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time interval from induction-to-delivey for vaginal deliveries | 48 hours | Maternal outcome |
| The number of vaginal births within 24 hours | 24 hours | Maternal outcome |
| The number of misoprostol doses received by each participant | 24 hours | Maternal outcome |
| The incidence of uterine tachysystole | 24 hours | Defined as greater than 5 contractions in a ten minute window, averaged over 30 minutes |
| The rate of each indication for the cesarean delivery | 48 hours | Indications include non-reassuring fetal hear tones, arrest of dilation, arrest in the 2nd stage of labor etc. |
| The rate of operative vaginal delivery | 48 hours | Maternal outcome - includes forceps or vacuum assisted deliveries |
| The rate of intra-amniotic infection | 48 hours | Maternal outcome |
| The rate of postpartum hemorrhage | 24 hours | Maternal outcome |
| The rate of Fetal heart rate abnormaliies | 48 hours | recurrent late decelerations, bradycardia, or prolonged deceleration |
| The number of patients that received betamethasone for fetal lung maturity and/or magnesium sulfate for fetal neuroprotection | 24 hours | Maternal outcome |
| The rate of stillbirth | 48 hours | Fetal/Neonatal outcome |
| The total rate of Neonatal Apgar scores less than 7 at 5 minutes | 5 minutes | Neonatal outcome |
| The total rate of Neonatal RDS | 96 hours | Neonatal outcome |
| The total rate of Neonatal admission to the NICU | 96 hours | Neonatal outcome |
| The total rate of neonatal arterial umbilical blood pH < 7.1 | 96 hours | Neonatal outcome |
| The rate of neonatal Sepsis | 96 hours | Neonatal outcome |
| The rate of Neonatal Death | 96 hours | Neonatal outcome |
Countries
United States
Outcome results
None listed