Clinical trial NCT03361124: Oxytocin Dosing at Planned Cesarean Section and Anemia
Official title: Oxytocin Dosing at Planned Cesarean Section and Postpartum Anemia: A Comparison of Two Protocols
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Blood Loss Anemia
Uterine Atony With Hemorrhage
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blinded controlled
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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:

* Women who receive the standard 20 mU of oxytocin in 1L of LR in bolus fashion plus 20 mU in 1L over 8 hours will have a decreased reduction in pre-operative vs post-operative hematocrit and hemoglobin versus those that receive 20 mU in 1L of LR.
* Women who receive the standard 20 mU of oxytocin in 1L of LR in bolus fashion plus 20 mU in 1L over 8 hours will have decreased blood loss by weight in the postpartum period compared to patients who receive 20 mU in 1L of LR.

Eligibility criteria: Inclusion Criteria:

* Planned cesarean sections for singletons at or greater than 37 weeks gestational age
* Primary or repeat cesarean section will be included

Exclusion Criteria:

* Multiple fetal pregnancies
* Hematologic disorders
* Fetal anomalies
* Pre-eclampsia. These patients are at increased risk of fluid overload and so fluid status may be affected by receiving a second bag of fluid containing oxytocin in the postpartum period.
* Known contraindication to oxytocin
* Hypersensitivity to oxytocin
* Patients who have labored and then proceed with cesarean section for any reason. Patients who have labored have had either intrinsic or extrinsic exposure to oxytocin. These patients may have decreased sensitivity to oxytocin.

Primary outcomes:
measure: Blood loss in postpartum period defined by grams/hour
timeFrame: 3-4 days after delivery
Secondary outcomes:
measure: Change in Hemoglobin
timeFrame: 24 hours
measure: Change in Hematocrit
timeFrame: 24 hours
measure: Length of hospital stay
timeFrame: 3-4 days after delivery
measure: Need for additional uterotonics
timeFrame: 24 hours after delivery
measure: Continuation of breastfeeding
timeFrame: 6 weeks
measure: Quantity of narcotic pain medications
timeFrame: 3-4 days after delivery
measure: Attendance at post-partum visit
timeFrame: 6 weeks
measure: Post-partum complications
timeFrame: 6 weeks
measure: Need for blood transfusion
timeFrame: 3-4 days after delivery
measure: Edinburgh post-partum depression scale >10
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Penn State College of Medicine
name: Helana Pietragallo, MD
role: PRINCIPAL_INVESTIGATOR
References: