Cesarean Section Clinical Trial
— MODEOfficial title:
Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions: A Randomized Control Trial
NCT number | NCT04492072 |
Other study ID # | 20D.435 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 17, 2020 |
Est. completion date | May 26, 2022 |
Verified date | June 2022 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 150 |
Est. completion date | May 26, 2022 |
Est. primary completion date | May 26, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Cesarean Delivery | Total rate of cesarean delivery | 48 hours | |
Secondary | The time interval from induction-to-delivey for vaginal deliveries | Maternal outcome | 48 hours | |
Secondary | The number of vaginal births within 24 hours | Maternal outcome | 24 hours | |
Secondary | The number of misoprostol doses received by each participant | Maternal outcome | 24 hours | |
Secondary | The incidence of uterine tachysystole | Defined as greater than 5 contractions in a ten minute window, averaged over 30 minutes | 24 hours | |
Secondary | The rate of each indication for the cesarean delivery | Indications include non-reassuring fetal hear tones, arrest of dilation, arrest in the 2nd stage of labor etc. | 48 hours | |
Secondary | The rate of operative vaginal delivery | Maternal outcome - includes forceps or vacuum assisted deliveries | 48 hours | |
Secondary | The rate of intra-amniotic infection | Maternal outcome | 48 hours | |
Secondary | The rate of postpartum hemorrhage | Maternal outcome | 24 hours | |
Secondary | The rate of Fetal heart rate abnormaliies | recurrent late decelerations, bradycardia, or prolonged deceleration | 48 hours | |
Secondary | The number of patients that received betamethasone for fetal lung maturity and/or magnesium sulfate for fetal neuroprotection | Maternal outcome | 24 hours | |
Secondary | The rate of stillbirth | Fetal/Neonatal outcome | 48 hours | |
Secondary | The total rate of Neonatal Apgar scores less than 7 at 5 minutes | Neonatal outcome | 5 minutes | |
Secondary | The total rate of Neonatal RDS | Neonatal outcome | 96 hours | |
Secondary | The total rate of Neonatal admission to the NICU | Neonatal outcome | 96 hours | |
Secondary | The total rate of neonatal arterial umbilical blood pH < 7.1 | Neonatal outcome | 96 hours | |
Secondary | The rate of neonatal Sepsis | Neonatal outcome | 96 hours | |
Secondary | The rate of Neonatal Death | Neonatal outcome | 96 hours |
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