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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Diphenhydramine 50mg IV will be administered within 1 hour of the cervical exam which diagnosed prolonged active phase of labor
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.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of participants that achieve complete dilation of cervix (10cm)
Time frame: from start of treatment upto 4 hours
Number of participants that achieve complete dilation of cervix (10cm)
Time frame: from start of treatment upto 6 hours
Number of participants who have vaginal delivery after protracted labor
Time frame: 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
Time frame: 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
Time frame: from birth up to 6 weeks post-delivery
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