A Phase 4 interventional study of Oxytocin in Blood Loss Anemia and Uterine Atony With Hemorrhage, sponsored by Milton S. Hershey Medical Center. Withdrawn. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-21.
Sponsored by Milton S. Hershey Medical Center · Phase 4, Interventional, and Prevention
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Patient's with planned cesarean sections will be randomized to receive either standard 20 mU in 1L as a bolus following delivery of the placenta or 20 mu in 1L following delivery of the placenta plus an additional 20 mU in 1L over 8 hours.
The purpose of this study is to examine the impact of differential dose protocols commonly utilized in the post cesarean period to determine if laboratory definitions of anemia are different. Oxytocin is an antidiuretic hormone that is utilized after delivery of the fetus and placenta to contract the uterus and decrease blood loss both at the time of surgery and in the post-partum period. Here at the Penn State Hershey Medical center the investigators will use 20 units of oxytocin in a 1 L bag of LR in bolus fashion after delivery of the placenta. Other protocols use an extended course of therapy using 20 units of oxytocin in a 1 L bag of LR in a bolus plus an additional 20 units of oxytocin in a 1 L bag of LR over an 8 hour period of time.
We hypothesize that:
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
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Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient will receive standard post-partum Oxytocin (20 mU in 1 L LR) and 1 L LR over 8 hours following delivery.
Drug: Oxytocin
Patient will receive standard post-partum Oxytocin(20 mU in 1 L LR) an additional 20 mU Oxytocin in 1 L LR over 8 hours following delivery.
Drug: Oxytocin
Administration of additional 20 mU Oxytocin
Also known as: Pitocin
Blood loss in postpartum period defined by grams/hour
Measure pads used post-partum
Time frame: 3-4 days after delivery
Change in Hemoglobin
Pre-op hemoglobin and post-op hemoglobin
Time frame: 24 hours
Change in Hematocrit
Pre-op hematocrit and post-op hematocrit
Time frame: 24 hours
Length of hospital stay
Start of surgery to discharge (hours)
Time frame: 3-4 days after delivery
Need for additional uterotonics
Use of uterotonics
Time frame: 24 hours after delivery
Continuation of breastfeeding
Is patient breastfeeding at 6 week post-partum visit
Time frame: 6 weeks
Quantity of narcotic pain medications
Number of narcotic tablets used from time of surgery to discharge
Time frame: 3-4 days after delivery
Attendance at post-partum visit
Did patient attend post-partum visit?
Time frame: 6 weeks
Post-partum complications
Did patient have surgical wound infection, endometritis?
Time frame: 6 weeks
Need for blood transfusion
Did the patient require blood transfusion?
Time frame: 3-4 days after delivery
Edinburgh post-partum depression scale >10
Did the patient score greater than 10 points on Edinburgh post-partum depression scale?
Time frame: 6 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Mar 2019; primary completion for Mar 2020, 12 months later.
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This study is withdrawn, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxytocin
Milton S. Hershey Medical Center →