Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
NCT Number: NCT04492072
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
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Female
Interventional
Not applicable
Philadelphia, Pennsylvania, 19107, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention
Other names: Mechanical Dilation
Control
Other names: Mechanical Dilation
Time frame: 48 hours
Total rate of cesarean delivery
Time frame: 48 hours
Maternal outcome
Time frame: 24 hours
Maternal outcome
Time frame: 24 hours
Maternal outcome
Time frame: 24 hours
Defined as greater than 5 contractions in a ten minute window, averaged over 30 minutes
Time frame: 48 hours
Indications include non-reassuring fetal hear tones, arrest of dilation, arrest in the 2nd stage of labor etc.
Time frame: 48 hours
Maternal outcome - includes forceps or vacuum assisted deliveries
Time frame: 48 hours
Maternal outcome
Time frame: 24 hours
Maternal outcome
Time frame: 48 hours
recurrent late decelerations, bradycardia, or prolonged deceleration
Time frame: 24 hours
Maternal outcome
Time frame: 48 hours
Fetal/Neonatal outcome
Time frame: 5 minutes
Neonatal outcome
Time frame: 96 hours
Neonatal outcome
Time frame: 96 hours
Neonatal outcome
Time frame: 96 hours
Neonatal outcome
Time frame: 96 hours
Neonatal outcome
Time frame: 96 hours
Neonatal outcome
Thomas Jefferson University
Other
Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions: A Randomized Control Trial
Acronym: MODE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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