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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03361124
Other study ID # 00006502
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date March 1, 2019
Est. completion date March 1, 2020

Study information

Verified date February 2019
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Oxytocin
Administration of additional 20 mU Oxytocin

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Blood loss in postpartum period defined by grams/hour Measure pads used post-partum 3-4 days after delivery
Secondary Change in Hemoglobin Pre-op hemoglobin and post-op hemoglobin 24 hours
Secondary Change in Hematocrit Pre-op hematocrit and post-op hematocrit 24 hours
Secondary Length of hospital stay Start of surgery to discharge (hours) 3-4 days after delivery
Secondary Need for additional uterotonics Use of uterotonics 24 hours after delivery
Secondary Continuation of breastfeeding Is patient breastfeeding at 6 week post-partum visit 6 weeks
Secondary Quantity of narcotic pain medications Number of narcotic tablets used from time of surgery to discharge 3-4 days after delivery
Secondary Attendance at post-partum visit Did patient attend post-partum visit? 6 weeks
Secondary Post-partum complications Did patient have surgical wound infection, endometritis? 6 weeks
Secondary Need for blood transfusion Did the patient require blood transfusion? 3-4 days after delivery
Secondary Edinburgh post-partum depression scale >10 Did the patient score greater than 10 points on Edinburgh post-partum depression scale? 6 weeks
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