Blood Loss AnemiaPhase 4NCT03361124
Oxytocin Dosing at Planned Cesarean Section and Anemia
A Phase 4 study testing Oxytocin in people with Blood Loss Anemia and Uterine Atony With Hemorrhage, run by Milton S. Hershey Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Loss Anemia, Uterine Atony With Hemorrhage
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 1 Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Planned cesarean sections for singletons at or greater than 37 weeks gestational age
- Primary or repeat cesarean section will be included
Who cannot join
- 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.
About this study
Official title: Oxytocin Dosing at Planned Cesarean Section and Postpartum Anemia: A Comparison of Two Protocols
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.
Read the 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.
- Conditions
- Blood Loss Anemia, Uterine Atony With Hemorrhage
- Being tested
- Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
Administration of additional 20 mU Oxytocin
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Patient will receive standard post-partum Oxytocin (20 mU in 1 L LR) and 1 L LR over 8 hours following delivery. Receives: Drug: Oxytocin |
| Treatment | Experimental | 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. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss in postpartum period defined by grams/hour
Measure pads used post-partum
Measured: 3-4 days after delivery
Secondary outcomes (10)
Change in Hemoglobin
Pre-op hemoglobin and post-op hemoglobin
Measured: 24 hours
Change in Hematocrit
Pre-op hematocrit and post-op hematocrit
Measured: 24 hours
Length of hospital stay
Start of surgery to discharge (hours)
Measured: 3-4 days after delivery
Need for additional uterotonics
Use of uterotonics
Measured: 24 hours after delivery
Continuation of breastfeeding
Is patient breastfeeding at 6 week post-partum visit
Measured: 6 weeks
Quantity of narcotic pain medications
Number of narcotic tablets used from time of surgery to discharge
Measured: 3-4 days after delivery
Attendance at post-partum visit
Did patient attend post-partum visit?
Measured: 6 weeks
Post-partum complications
Did patient have surgical wound infection, endometritis?
Measured: 6 weeks
Need for blood transfusion
Did the patient require blood transfusion?
Measured: 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?
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Mar 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Why it stopped: Investigator no longer interested in proceeding with study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss AnemiaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blinded controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helana Pietragallo, Milton S. Hershey Medical Center
- Investigators
- Helana Pietragallo, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361124
- Sponsor's protocol ID
- 00006502
- Status last verified
- Feb 2019
- First submitted
- 1 Aug 2017
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin Dosing at Planned Cesarean Section and Postpartum Anemia: A Comparison of Two Protocols
- ClinicalTrials.gov ID
- NCT03361124
- Acronym / sponsor ID
- 00006502
- Conditions
- Blood Loss Anemia, Uterine Atony With Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator no longer interested in proceeding with study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized double-blinded controlled
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: OxytocinPatient will receive standard post-partum Oxytocin (20 mU in 1 L LR) and 1 L LR over 8 hours following delivery. |
| Treatment | Experimental | Drug: OxytocinPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned cesarean sections for singletons at or greater than 37 weeks gestational age
- Primary or repeat cesarean section will be included
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: PitocinAdministration of additional 20 mU Oxytocin | Drug | Control, Treatment |
Primary outcome
Blood loss in postpartum period defined by grams/hour
Time frame: 3-4 days after delivery
Measure pads used post-partum
10 secondary outcomes
Change in Hemoglobin
Time frame: 24 hours
Change in Hematocrit
Time frame: 24 hours
Length of hospital stay
Time frame: 3-4 days after delivery
Need for additional uterotonics
Time frame: 24 hours after delivery
Continuation of breastfeeding
Time frame: 6 weeks
Quantity of narcotic pain medications
Time frame: 3-4 days after delivery
Attendance at post-partum visit
Time frame: 6 weeks
Post-partum complications
Time frame: 6 weeks
Need for blood transfusion
Time frame: 3-4 days after delivery
Edinburgh post-partum depression scale >10
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helana Pietragallo, MD principal investigator
Penn State College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin in people with Blood Loss Anemia and Uterine Atony With Hemorrhage, run by Milton S. Hershey Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss in postpartum period defined by grams/hour (time frame: 3-4 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.