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The Obese Pitocin Study (OPS)

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ClinicalTrials.gov Identifier: NCT03140488
Recruitment Status : Completed
First Posted : May 4, 2017
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Meghan Hill, University of Arizona

Brief Summary:

Obesity is considered one of the biggest public health concern of the 21st century and increases the risk of many comorbid medical conditions. Obesity in pregnancy places women at higher risk of obstetrical complications during pregnancy, delivery and postpartum. In particular, obese pregnant women have more difficulty going into labor, a longer labor course, and even with pharmacologic treatment, have a higher chance of requiring cesarean delivery.

When pregnant women need help going into labor, they commonly receive a medication called Pitocin on the labor and delivery floor. Pitocin is the brand name and is a synthetic analog to the naturally produced oxytocin, a hormone secreted by mother when they naturally go into labor. This medication has been used widely around the world. There is emerging evidence that obese women need more oxytocin to go into labor compared to their lean cohorts. There are many studies to support the use of different oxytocin dosages and are currently supported by the American College of Obstetricians and Gynecologists. Despite these evidences, a low dose oxytocin regimen is universally used in the United States, regardless of patient characteristics.

This study is a double blinded randomized controlled trial. Both lean and obese cohorts will be recruited for the study. The investigators will randomly place both cohorts into the low or the high dose oxytocin regimen treatment group. The investigators, patients and providers will be blinded and will not know the specific assignments. The purpose of this study is to evaluate the effect of high dose oxytocin in the obese cohort. The hypothesis is that obese patient will have shorter time to delivery with the high dose oxytocin regimen without incurring any additional risks or adverse outcomes.


Condition or disease Intervention/treatment Phase
Obesity Labor, Induced Oxytocin Drug: Oxytocin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

4 Comparison groups:

  1. Control group: Lean cohort: BMI ≤25, at <20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol
  2. Intervention group: Lean cohort: BMI ≤25, at <20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol
  3. Control group: Obese cohort: BMI ≥30, at <20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol
  4. Intervention group: Obese cohort: BMI ≥30, at <20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This portion of the study will be carried out by the research pharmacy. Single (low dose) and triple (high dose) concentration of oxytocin will be premixed in the intravenous fluid bag in the pharmacy. Sequence generation for randomization will be created with 1:1 ratio in both the obese and lean group by the Department of Statistics. After the sequence is generated, ths list will be given to the research pharmacy. The premixed oxytocin medication will be sequentially labelled as "OPS drug, patient #1, 2, 3" etc. per the allocation. Allocation concealment will also be carried out by pharmacy as these bags will completely appear identical after they are labelled numerically. Once a patient is randomized, the pharmacy will send up the appropriate concentration of oxytocin already premixed in the intravenous fluid bag, labelled as "OPS drug, patient #". Lean group will be assigned at # 1-70 and obese group will be assigned at #71-140.
Primary Purpose: Other
Official Title: High Dose vs. Low Dose Oxytocin for Labor Induction in Obese Women: a Randomized Controlled Trial - the OPS (Obese Pitocin Study) Trial
Actual Study Start Date : June 5, 2017
Actual Primary Completion Date : October 12, 2018
Actual Study Completion Date : September 5, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
No Intervention: Lean-Control

1) Control group: Lean cohort: BMI ≤25, at <20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol

Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.

Experimental: Lean-Intervention

2) Intervention group: Lean cohort: BMI ≤25, at <20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol

High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.

Drug: Oxytocin
Patients will be randomized to low dose or high dose oxytocin for induction of labor.

No Intervention: Obese-Control

3) Control group: Obese cohort: BMI ≥30, at <20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol

Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.

Experimental: Obese-Intervention

4) Intervention group: Obese cohort: BMI ≥30, at <20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol

High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.

Drug: Oxytocin
Patients will be randomized to low dose or high dose oxytocin for induction of labor.




Primary Outcome Measures :
  1. Length of time to delivery [ Time Frame: Start of induction to Delivery ]
    Number of minutes from induction of labor to delivery. In case of cesarean delivery, length of time to delivery will be calculated from start time of induction to time when decision was made to proceed with cesarean delivery.


Secondary Outcome Measures :
  1. Length of time in 1st stage and 2nd stage of labor [ Time Frame: time from induction to delivery, will be recorded via chart review after delivery ]
    time in minutes

  2. Total amount of oxytocin [ Time Frame: Start of induction to Delivery ]
    amount measured in milliunits

  3. Median, mean, and maximum oxytocin rate [ Time Frame: Start of induction to Delivery ]
    rate measured in milliunits/minute

  4. Terbutaline use [ Time Frame: Start of induction to Delivery ]
    If terbutaline was used or not and how much

  5. Rate of cesarean delivery [ Time Frame: Start of induction to Delivery ]
    total number of patients who undergo cesarean delivery

  6. Rate of cesarean delivery for labor arrest [ Time Frame: Start of induction to Delivery ]
    Number of patients who undergo cesarean delivery due to labor arrest

  7. Maternal complications [ Time Frame: Duration of admission, on average not more than 7 days ]
    Any time of maternal complication, including but not limited to: Postpartum hemorrhage, uterine rupture, tachysystole, chorioamnionitis

  8. Neonatal complications [ Time Frame: Duration of maternal and neonatal admission, on average not more than 7 days ]
    Any time of neonatal complication, including but not limited to: abnormal fetal heart tracing, fetal Apgar, neonatal intensive care unit admission rate, cord gas



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy ≥ 37 weeks gestation
  • Patient presented for induction of labor who is determined to be a candidate for oxytocin
  • Cephalic presentation
  • Reassuring fetal health assessment (no abnormal findings in fetal assessment, see below)
  • Meeting one of the following BMI category:

Obese group: BMI ≥30 at <20 weeks of pregnancy, or BMI ≥35 at a term gestation of pregnancy Lean group: BMI ≤25 at <20 weeks of pregnancy, or BMI ≤28 at a term gestation of pregnancy

Exclusion Criteria:

  • Non-reassuring fetal assessment at the time of recruitment
  • Previous cervical ripening agents (cytotec, cervidil, cervical Foley Balloon)
  • <18 years of age
  • Prisoners
  • Any patients contraindicated for vaginal delivery
  • Multiple gestations
  • History of previous cesarean delivery
  • Patients with history of significant cardiac disease
  • Fetal demise
  • Estimated fetal weight greater than 4500 grams in diabetic and 5000 grams in non-diabetic mother
  • Ruptured membranes
  • Spontaneous labor (latent or active phase)
  • Augmentation of labor (latent or active phase)

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): NCT03140488


Locations
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United States, Arizona
Banner University Medical Center Tucson
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Meghan Hill, MBBS University of Arizona
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Responsible Party: Meghan Hill, Assistant Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT03140488    
Other Study ID Numbers: 1702231223
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Meghan Hill, University of Arizona:
Induction of labor
Pitocin
BMI
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs