Labor Dystocia
Conditions
Keywords
dilation, labor
Brief summary
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.
Interventions
DRUGTreatment with Diphenhydramine
Diphenhydramine 50mg IV will be administered within 1 hour of the cervical exam which diagnosed prolonged active phase of labor
COMBINATION_PRODUCTUsual 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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
* Category II or III tracing * Allergy to the study medication (IV Diphenhydramine)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants that achieve complete dilation of cervix (10cm) | from start of treatment upto 4 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | from hospitalization up to 6 weeks postpartum | This includes postpartum hemorrhage, cervical lacerations or intraamniotic infection |
| Number of neonates that had adverse events | from birth up to 6 weeks post-delivery | 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 |
Countries
United States
Contacts
CONTACTSamantha Antonioli, MD
CONTACTAaron Roberts
PRINCIPAL_INVESTIGATORSamantha Antonioli, MD
The University of Texas Health Science Center, Houston
Outcome results
None listed