Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multimodal Uterotonics at the Time of Cesarean Section in Laboring Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03904446
Recruitment Status : Not yet recruiting
First Posted : April 5, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Nicole M. Masse, University of Iowa

Brief Summary:

Postpartum hemorrhage remains a leading cause of maternal morbidity and mortality worldwide, even in high income countries. Uterine atony is estimated to cause 70-80% of postpartum hemorrhage. Prolonged labor and augmented labor are known risk factors for postpartum hemorrhage. In attempts to reduce the incidence of postpartum hemorrhage, particularly in patients with known risks factors, it is essential to optimize preventative practices in order to reduce the rates postpartum hemorrhage.

Although oxytocin is considered the first line therapy for preventing and treating uterine atony, early consideration of additional prophylactic uterotonic agents may be indicated in women with prior oxytocin exposure given oxytocin receptor desensitization and down regulation.

As such, investigators sought to examine whether multimodal prophylactic uterotonics (standard oxytocin + methylergonovine), in patients who are increased risk of developing postpartum hemorrhage (specifically laboring patients who ultimately require a cesarean section) would benefit from the addition of prophylactic uterotonics. The clinical rational for administration of multimodal prophylactic uterotonics at the time of cesarean delivery in laboring patients is three-fold: to decrease the incidence of uterine atony, to decrease the incidence of postpartum hemorrhage, decrease the number of uterotonics required at the time of cesarean section.

The primary outcome will be to evaluate the need for additional uterotonic agents (Methylergonovine, Carboprost, Misoprostol) at the time of delivery.

Secondary outcomes will include the incidence of postpartum hemorrhage (quantitative blood loss >1 liter), surgical assessment of uterine tone four minutes following delivery of the placenta, preoperative and postoperative hemoglobin, the need for a blood transfusion, intensive care unit admission, uterine infection (endometritis).


Condition or disease Intervention/treatment Phase
Uterine Atony With Hemorrhage Drug: Methylergonovine Drug: Normal Saline (placebo) Phase 4

Detailed Description:

All patients who meet eligibility for the study will be consented during their clinic visit or upon arrival to labor and delivery. If patients elect to participate in the study, enrollment in the study will be noted in their sticky note in EPIC (electronic medical record) which will be ready available to all members of the health care team. If patients during the labor process require a cesarean section, the anesthesiologist will pick up a sealed envelope (which will contain the allocation sequence and group assignment). A randomization block design with mixed block sizes will be used to generate the allocation sequence by using the nQuery Advisor computer software.

The sealed envelopes will be readily available to the anesthesiologist and kept in the anesthesia workroom. Following delivery of the infant, the patient will receive the standard oxytocin infusion. Following administration of the oxytocin infusion, the patient will be given either methylergonovine 0.2 mg IM (intramuscular) or placebo (1 ml of normal saline, intramuscular). This will be drawn up and administered by the anesthesiologist. The obstetrician (delivering provider performing the cesarean section) will be blinded to the group assignment. Documentation of the drug will be recorded in epic in the medication administration record.

The delivering provider will be responsible for determining and relaying to the anesthesiologist whether additional uterotonics are needed throughout the procedure. Additional uterotonics will be given in accordance to the current guidelines outlined by the American Congress of Obstetricians and Gynecologists (ACOG). The delivery provider will assess uterine tone at 4 minutes (satisfactory versus unsatisfactory). The registered nurse will be responsible for setting up a timer to let the OB provider know when 4 minutes have passed. Nursing will call out once the 4 minutes have passed and the OB provider will state whether adequate tone was noted. The anesthesiologist will be responsible for documenting whether a placebo/study drug was given and uterine tone after 4 minutes. This documentation will be placed back into the sealed envelope by the anesthesiologist and placed in the anesthesia workroom. Nicole Masse (primary investigator) will be responsible for storing folders in a secured, locked file cabinet within the Maternal Fetal Medicine offices.

As routinely done at the time of cesarean delivery, the registered nurse will be responsible for measuring and documenting the quantitative blood loss. As routinely performed on all are patients who undergo a vaginal or cesarean delivery, preoperative hemoglobin and postoperative day one hemoglobin levels will be collected.

In the event a delayed postpartum hemorrhage was to occur, the obstetrician will be un-blinded at the conclusion of the cesarean delivery as management of a delayed hemorrhage will be driven by the uterotonics received in the operating room. Because all drugs administered during the procedure will be documented in the patients medical record, the obstetrician will have access to the medications given during the cesarean section.

The primary outcome, the need for additional uterotonics, will be assessed in the operating room. Other outcome which will be assessed in the operating room include uterine tone and quantitative blood loss. Outcomes which will be assessed in the immediate postpartum period include: postpartum hemoglobin values, need for a blood transfusion, admission to the intensive care unit, endometritis).

No long-term follow will be needed.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial to Assess the Effectiveness of Multimodal Prophylactic Uterotonics in Patients Undergoing Non-Elective Cesarean Sections After a Trial of Labor
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methylergonovine 0.2 mg
Standard Oxytocin Infusion at the time of Cesarean Section plus 0.2 mg of Intramuscular Methergine
Drug: Methylergonovine
0.2 mg of intramuscular methylergonovine at the time of cesarean section following standard IV oxytocin infusion.

Placebo Comparator: Placebo (Normal Saline)
Standard Oxytocin Infusion at the time of Cesarean Section plus 1 milliliter (mL)of normal saline given intramuscular
Drug: Normal Saline (placebo)
1 ml of normal saline intramuscular at the time of cesarean section following standard IV oxytocin infusion




Primary Outcome Measures :
  1. Need for additional uterotonics (methylergonovine, carboprost, misoprostol) [ Time Frame: Assessed from the time of cesarean section until 24 hours postdelivery ]
    Categorical Variable (Yes/No) - Depending on whether patients required additional uterotonic agents


Secondary Outcome Measures :
  1. Quantitative Blood Loss [ Time Frame: Quantiative Blood Loss is measured at the completion of the cesarean delivery ]
    As per protocol, nurses will measure the quantitative blood loss by measuring the blood in the canisters used during the cesarean section and by weighing the sponges used in the surgery.

  2. Hemoglobin [ Time Frame: Preoperative hemoglobin level is collected on arrival to labor and delivery prior to the cesarean section, postoperative hemoglobin is collected on postoperative day one. ]
    As per standard protocol, preoperative and postoperative day one hemoglobin levels will be evaluated

  3. Uterine Atony [ Time Frame: Obstetricians will assess the uterine tone 4 minutes following delivery of the infant ]
    Nursing will notify the obstetrical provider 4 minutes following delivery of the infant and the obstetrical provider will determine whether the uterine tone is noted to be satisfactory (uterus is contracted) or unsatisfactory (uterus boggy)

  4. Need for Blood Transfusion [ Time Frame: The need for a blood transfusion during the cesarean section up until hospital discharge (which is typically postpartum day number 3 for patients undergoing cesarean delivery) ]
    The number of patients who required a blood transfusion

  5. Intensive Care Unit Admission [ Time Frame: Admission to the intensive care unit would typically take place following the cesarean delivery ]
    The number of patients who required admission to the intensive care unit following delivery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Yes. Pregnant women are the only eligible subjects.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age
  • Laboring patients who undergo a cesarean section

Exclusion Criteria:

  • Placenta/Uterine Abnormalities
  • Chronic Hypertension, Gestational Hypertension, Preeclampsia
  • HIV/AIDS on protease inhibitors
  • History of Coronary Artery Disease
  • History of Hypersensitivity to Methylergonovine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904446


Contacts
Layout table for location contacts
Contact: Nicole M Masse, MD 319-356-7189 nicole-masse@uiowa.edu

Locations
Layout table for location information
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Nicole M. Masse
Investigators
Layout table for investigator information
Principal Investigator: Nicole M Masse, MD University of Iowa

Publications:
Layout table for additonal information
Responsible Party: Nicole M. Masse, Fellow Physician, University of Iowa
ClinicalTrials.gov Identifier: NCT03904446     History of Changes
Other Study ID Numbers: pending IRB number
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Nicole M. Masse, University of Iowa:
Methergine
Uterine Atony

Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Uterine Inertia
Pathologic Processes
Dystocia
Obstetric Labor Complications
Pregnancy Complications
Oxytocin
Methylergonovine
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs