Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2024-12-01
2025-12-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment with Diphenhydramine
Treatment with Diphenhydramine
Diphenhydramine 50mg IV will be administered within 1 hour of the cervical exam which diagnosed prolonged active phase of labor
Usual Care
Participants will receive cervical exams every 2 hours in active labor, placement of intrauterine pressure catheter, up titration of Pitocin if contractions are inadequate, maternal repositioning, and use of adjunct devices such as a peanut ball.
Usual Care
Usual Care
Participants will receive cervical exams every 2 hours in active labor, placement of intrauterine pressure catheter, up titration of Pitocin if contractions are inadequate, maternal repositioning, and use of adjunct devices such as a peanut ball.
Interventions
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Treatment with Diphenhydramine
Diphenhydramine 50mg IV will be administered within 1 hour of the cervical exam which diagnosed prolonged active phase of labor
Usual Care
Participants will receive cervical exams every 2 hours in active labor, placement of intrauterine pressure catheter, up titration of Pitocin if contractions are inadequate, maternal repositioning, and use of adjunct devices such as a peanut ball.
Eligibility Criteria
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Inclusion Criteria
* Viable single intrauterine pregnancy
-≥ 34 weeks of gestation
* Ruptured membranes
* Category I tracing at time of inclusion
* Active phase of labor (\>=6 cm of cervix dilation)
Exclusion Criteria
* Allergy to the study medication (IV Diphenhydramine)
18 Years
FEMALE
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Samantha Antonioli
Resident
Principal Investigators
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Samantha Antonioli, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-MS-24-0841
Identifier Type: -
Identifier Source: org_study_id
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