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Prostaglandin E1 Analog

Oxytocin for Patient-Reported Outcome Measures (PROMs) (POM PROM Trial)

Q: Has the FDA sanctioned Oxytocin for medical use?

<p>We have assigned a score of 3 for <a href="https://www.withpower.com/clinical-trials/oxytocin">Oxytocin</a>'s safety due to the fact that this is already an approved treatment, as evidenced by its Phase 4 trial status.</p>

Phase 4

Waitlist Available

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English Speaking

Nulliparous

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment to 1 week postpartum

Awards & highlights

POM PROM Trial Summary

This trial is testing whether oxytocin or oral misoprostol results in a shorter interval to delivery after the start of induction among nulliparous women with unfavorable cervical exams and term premature rupture of membranes.

Eligible Conditions

Patient-Reported Outcome Measures (PROMs)

POM PROM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You must be able to speak English.

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You have never given birth to a child.

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The baby is in the correct position for delivery.

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Your cervix is not dilated more than 2 centimeters and your Bishop score is less than 8.

POM PROM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment to delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment to delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time from IOL to delivery

Secondary outcome measures

Cesarean delivery

Infection

Maternal morbidity

+4 more

POM PROM Trial Design

2Treatment groups

Active Control

Group I: OxytocinActive Control1 Intervention

IV Oxytocin 2mU/min, increased by 2mU/min q15 minutes per hospital protocol

Group II: Oral MisoprostolActive Control1 Intervention

Oral misoprostol 50 mcg q4H for up to 6 doses or until cervical ripening is no longer indicated

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,879,980 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions is Oxytocin generally prescribed to ameliorate?

"Oxytocin can be administered to address the effects of nsaid use, labour, and uterine contractions."

Answered by AI

What is the scope of enrollment for this clinical investigation?

"Yes, the information on clinicaltrials.gov attests that this medical trial is actively recruiting patients. This project was first made public on August 12th 2019 and has been recently updated on July 18th 2022. 155 participants need to be enlisted from one location for enrollment purposes."

Answered by AI

Has the FDA sanctioned Oxytocin for medical use?

"We have assigned a score of 3 for Oxytocin's safety due to the fact that this is already an approved treatment, as evidenced by its Phase 4 trial status."

Answered by AI

Does this trial have any openings for participants at the moment?

"Affirmative. The chronology listed on clinicaltrials.gov shows that this medical trial was first posted on August 12th 2019 and is currently seeking participants, with the most recent edit being made July 18th 2022. 155 patients must be recruited from a single site for the study to continue apace."

Answered by AI

Recent research and studies

American Journal of Obstetrics and GynecologyJournal

Oral Misoprostol for Premature Rupture of Membranes at Term

Crane, Joan M.G., Tina Delaney, and Donna Hutchens. 2003. “Oral Misoprostol for Premature Rupture of Membranes at Term”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1067/s0002-9378(03)00768-3.

BJOG: An International Journal of Obstetrics and GynaecologyJournal

Labour Characteristics and Uterine Activity: Misoprostol Compared with Oxytocin in Women at Term with Prelabour Rupture of the Membranes

Ngai, Suk Wai, Yik Ming Chan, Sze Wing Lam, and Terence T. Lao. 2000. “Labour Characteristics and Uterine Activity: Misoprostol Compared with Oxytocin in Women at Term with Prelabour Rupture of the Membranes”. BJOG: An International Journal of Obstetrics and Gynaecology. Wiley. doi:10.1111/j.1471-0528.2000.tb11693.x.

Obstetrics & GynecologyJournal

The American College of Obstetricians and Gynecologists

“The American College of Obstetricians and Gynecologists”. 2018. “The American College of Obstetricians and Gynecologists”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002455.

International Journal of Gynecology & ObstetricsJournal