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Oxytocin

Phase 3

Cervical Ripening | Small molecule | Other |Community Health Systems, Inc.|Last Updated: May 4, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment180

FDA Designations

No designations recorded

Clinical trial landscape

Oxytocin · 1 trial · 3 indications

Phase 3 1
NCT03138252Study of the Effectiveness of Cervical Ripening Balloon With and Without OxytocinCervical Ripening
COMPLETED180 Analytics
PHASE3COMPLETED
Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin
Cervical RipeningUnlock trial analytics

Study Endpoints

Primary Endpoints

Time From Cervical Ripening to Delivery
Time to delivery

Time from placement of cervical ripening balloon to delivery

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cervical Ripening Balloon AloneACTIVE_COMPARATORMultiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
Cervical Ripening Balloon + OxytocinACTIVE_COMPARATORMultiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.

Interventions

NameTypeDescription
OxytocinDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age \> 18 years * Gestational age \> 34 + 0/7 weeks * Prior spontaneous vaginal delivery * Clinical or U/S EFW of \<4500 grams * Singleton gestation * Cervical dilation \<2 cm Exclusion Criteria: * Any contraindication to cervical ripening balloon, pitocin, or vaginal delive...

Countries:United States
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Frequently asked questions about Oxytocin

What is Oxytocin used for in cervical ripening?

Oxytocin is a small molecule being studied for cervical ripening and induction of labor. It is being evaluated in a Phase 3 clinical trial in the United States. The study includes women aged 18 years and older who are undergoing cervical ripening, with a focus on multiparity.

Who makes Oxytocin?

Oxytocin is being developed by Community Health Systems, Inc., a company traded on the New York Stock Exchange under the ticker CYH. The company is conducting clinical research on the drug for cervical ripening and induction of labor.

What phase is Oxytocin in?

Oxytocin is in Phase 3 clinical development for cervical ripening and induction of labor. It is an investigational drug and has not been approved by the FDA. One Phase 3 trial has been completed, with no active trials currently ongoing.

What clinical trials is Oxytocin in?

Oxytocin is being studied in the clinical trial NCT03138252, titled 'Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin.' This Phase 3 trial was completed in the United States and enrolled 180 participants. The trial was randomized and active-controlled, comparing oxytocin against a cervical ripening balloon.

Is Oxytocin the same as other drugs for labor induction?

Oxytocin is a distinct drug being studied for cervical ripening and induction of labor. It is being evaluated in combination with or compared to a cervical ripening balloon in clinical trials. The drug is administered to women undergoing labor induction, and its effectiveness is being assessed in a Phase 3 study.