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The purpose of this study is to is to determine the clinical effectiveness of a single dose of intravenous (IV) medication for the prevention of labor arrest and cesarean delivery in primiparous women undergoing trial of labor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Diphenhydramine | Experimental |
| |
| Usual Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with Diphenhydramine | Drug | Diphenhydramine 50mg IV will be administered within 1 hour of the cervical exam which diagnosed prolonged active phase of labor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that achieve complete dilation of cervix (10cm) | from start of treatment upto 4 hours | |
| Number of participants that achieve complete dilation of cervix (10cm) | from start of treatment upto 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who have vaginal delivery after protracted labor | End of delivery (an average of upto 6 hours after start of treatment) | |
| Number of participants who have Postpartum complications captured as composite maternal morbidity | This includes postpartum hemorrhage, cervical lacerations or intraamniotic infection |
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Inclusion Criteria:
Primiparous
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samantha Antonioli, MD | Contact | (713) 566-5735 | Samantha.Hentosh@uth.tmc.edu | |
| Aaron Roberts | Contact | (713) 500-6412 | Aaron.W.Roberts@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Samantha Antonioli, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D004420 | Dystocia |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
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| Usual Care | Combination Product | 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. |
|
| from hospitalization up to 6 weeks postpartum |
| Number of neonates that had adverse events | Adverse events include 5 minute APGAR SCORES less than 7, Respiratory Support with intubation in the delivery room , Neonatal intensive acre unit (NICU) admission, Fetal Anomalies, Infection, Intraventricular Hemorrhage, Hypoglycemia, Retinopathy of prematurity, Injuries, Fractures | from birth up to 6 weeks post-delivery |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |