Clinical trial NCT04492072: Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions
Official title: Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Misoprostol
Oxytocin
High Risk Pregnancy
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Rate of Cesarean Delivery
timeFrame: 48 hours
Secondary outcomes:
measure: The time interval from induction-to-delivey for vaginal deliveries
timeFrame: 48 hours
measure: The number of vaginal births within 24 hours
timeFrame: 24 hours
measure: The number of misoprostol doses received by each participant
timeFrame: 24 hours
measure: The incidence of uterine tachysystole
timeFrame: 24 hours
measure: The rate of each indication for the cesarean delivery
timeFrame: 48 hours
measure: The rate of operative vaginal delivery
timeFrame: 48 hours
measure: The rate of intra-amniotic infection
timeFrame: 48 hours
measure: The rate of postpartum hemorrhage
timeFrame: 24 hours
measure: The rate of Fetal heart rate abnormaliies
timeFrame: 48 hours
measure: The number of patients that received betamethasone for fetal lung maturity and/or magnesium sulfate for fetal neuroprotection
timeFrame: 24 hours
measure: The rate of stillbirth
timeFrame: 48 hours
measure: The total rate of Neonatal Apgar scores less than 7 at 5 minutes
timeFrame: 5 minutes
measure: The total rate of Neonatal RDS
timeFrame: 96 hours
measure: The total rate of Neonatal admission to the NICU
timeFrame: 96 hours
measure: The total rate of neonatal arterial umbilical blood pH < 7.1
timeFrame: 96 hours
measure: The rate of neonatal Sepsis
timeFrame: 96 hours
measure: The rate of Neonatal Death
timeFrame: 96 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References: