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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2022
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oxytocin
Intervention
Misoprostol
Control

Locations

Country Name City State
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

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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