Postpartum Hemorrhage Clinical Trial
Official title:
How's the Tone? Intravenous Versus Intramuscular Administration of Methylergonovine for Uterine Contraction in Cesarean Sections
Verified date | July 2020 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Insufficient uterine tone resulting in atony can potentiate hemorrhage and adverse outcomes
for the parturient. Oxytocin is the first pharmacologic agent used, followed by
methylergonovine, carboprost, and misoprostol. The American Congress of Obstetricians and
Gynecologists (ACOG) recommends the sequential use of oxytocin, followed by methylergonovine,
carboprost, misoprostol, then surgical intervention for cases of refractory uterine atony.
Many studies have examined the effect and dosage of intravenous uterotonics, including
oxytocin.
Although there are anecdotal reports of using intravenous bolus or rapid infusion of
methylergonovine, no randomized trial has compared efficacy and side effects of these two
routes of administration. Investigators hypothesize that intravenous methylergonovine reduces
the time to adequate uterine tone (the tone at which the uterus is adequately contracted to
prevent atony after delivery of neonate), decreases the total dose of methylergonovine to
contract the uterus, and therefore produces fewer side effects of hypertension, nausea, and
vomiting. Reducing the time to achieve adequate uterine tone is likely to decrease postpartum
hemorrhage.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2020 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All patients admitted for elective cesarean section - All laboring patients for planned vaginal delivery as these women may have an unplanned cesarean delivery for maternal or for fetal indications - Patients not in labor but admitted for non-elective cesarean section - Administration of oxytocin prior to administration of methylergonovine, in accordance to the ACOG guideline for postpartum hemorrhage - Obstetrician's request for methylergonovine intraoperatively to the anesthesiologist Exclusion Criteria: - Fetus not considered to be of viable gestational age by obstetrical team - Patients with hypertension (either chronic or pregnancy-induced, including preeclampsia) - Patients with coronary artery disease, established and diagnosed by medical internist or cardiologist - Patients taking CYP3A4 inhibitors - Patients taking beta blockers. - Patients with contraindications to any of the uterotonic agents for whatever medical reason (allergies, for example) - Surgeon request for administration of methylergonovine earlier than per protocol due to clinical situation as abovementioned - Maternal or obstetrician refusal - Patients who require obstetrical intervention before 30 minutes has elapsed |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to achieve "adequate" uterine tone | Our primary objective is to determine the time to achieve "adequate" uterine tone with either intramuscular (IM) dose versus intravenous (IV) dose methylergonovine, when oxytocin has failed to do so in cesarean sections. | 10 minutes | |
Secondary | Dose that achieves "adequate" uterine tone | Determining dose that achieves "adequate" uterine tone as defined by obstetricians on a qualitative numerical scale defined prior to the study (0 to 10 with 0 being inability of uterus to contract (i.e. uterine atony) to 10 being fully contracting uterus; "adequate" would be >5 on the scale) | 3 minutes | |
Secondary | Need for additional uterotonic agents | Quantifying need for additional uterotonic agents as outlined by the postpartum hemorrhage guidelines set forth by ACOG | 3 minutes | |
Secondary | Frequency of side effects of methylergonovine | Determining frequency of side effects of methylergonovine, including blood pressure changes, especially if elevated >20% preoperative level), headache, nausea, and vomiting | 30 minutes | |
Secondary | Need for vasopressors | To determine if the patient requires a vasopressor (including phenylephrine, ephedrine, epinephrine, norepinephrine or vasopressin)? | 3 minutes | |
Secondary | Estimated blood loss | Utilizing estimated blood loss by suction canister + estimated weight of blood on surgical lap | 2 hours | |
Secondary | Computed blood loss | Calculating changes in hematocrit (Hct preop - Hct postop) | 2 hours |
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