Health TrialsbyHealthPanel

Anticholinergics for Cervical Edema in Labor

ConditionLabor Dystocia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primiparous

Viable single intrauterine pregnancy

Ruptured membranes

Category I tracing at time of inclusion

Disqualifiers

Category II or III tracing

Allergy to the study medication (IV Diphenhydramine)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treatment with Diphenhydramine

    Drug

    Diphenhydramine 50mg IV will be administered within 1 hour of the cervical exam which diagnosed prolonged active phase of labor

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Treatment with DiphenhydramineExperimental treatment 2 interventions
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants that achieve complete dilation of cervix (10cm)

Time frame
from start of treatment upto 4 hours
2

Number of participants that achieve complete dilation of cervix (10cm)

Time frame
from start of treatment upto 6 hours

Secondary outcomes

1

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)
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov
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