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BMI-Associated Labor Induction: A Prospective Trial (BALI)

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ClinicalTrials.gov Identifier: NCT04035382
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Baystate Medical Center

Brief Summary:
The primary objective of this study is to determine if planned induction of labor at 39 weeks for nulliparous with pre-pregnancy BMI ≥ 35 kg/m2 reduces the incidence of cesarean section compared to expectant management

Condition or disease Intervention/treatment Phase
Labor Induction Procedure: Labor induction Not Applicable

Detailed Description:
Obesity in the obstetric population has reached epidemic proportions, affecting over 30% of reproductive-aged women in the United States (1). The increase in this morbidity is associated with large increases in cesarean delivery over the non-obese obstetric population and resultant post-operative complications are also higher in obese women (2). There are no interventions proven to reduce the risk of cesarean in obese women. The aim of this research study is to determine if induction of labor at 39 weeks can reduce the incidence of cesarean delivery over routine obstetric care (expectant management).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Simon two-stage
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BMI-Associated Labor Induction: A Prospective Trial
Estimated Study Start Date : July 17, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Labor Induction
Induction of labor between 39 0/7 to 39 6/7 weeks. Cervical ripening and induction method will be left to the managing clinician. However, combination method of cervical ripening with prostaglandin or oxytocin and Foley catheter, followed by oxytocin infusion and amniotomy will be encouraged.
Procedure: Labor induction
The study intervention is labor induction from 39 0/7 to 39 6/7 weeks. The individual labor induction process will be at the discretion of the physician or midwife managing the subject's care. Methods of induction that may be used include misoprostol, intracervical Foley catheter, oxytocin, and/or amniotomy. Participating clinicians will be encouraged to use only one course of cervical ripening followed by oxytocin infusion and amniotomy.
Other Names:
  • Foley catheter
  • Misoprostol
  • Oxytocin
  • Amniotomy




Primary Outcome Measures :
  1. Incidence of cesarean section [ Time Frame: Admission for induction to discharge from delivery admission, up to 3 weeks after enrollment. ]
    The primary outcome is to determine whether planned induction of labor at 39 weeks for obese nulliparous women changes the incidence of cesarean section.


Secondary Outcome Measures :
  1. Incisional extensions at cesarean section [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    J or T shape incisions or cervical trauma

  2. Operative vaginal delivery and indication [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    Vacuum or forceps

  3. Suspected intraamniotic infection [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    At least one maternal fever ≥100.4 F with at least one additional clinical sign of maternal tachycardia, fetal tachycardia, uterine tenderness or purulent/foul smelling vaginal discharge

  4. 3rd or 4th degree perineal laceration [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  5. Maternal death [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  6. Antepartum, intrapartum, or neonatal death [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  7. Admission to the intensive care unit (ICU) [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  8. Preeclampsia [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]

    Preeclampsia without severe features: Elevated blood pressure after 20 weeks ≥140/90 on 2 occasions at least 4 hours apart with previously normal blood pressure AND,

    • proteinuria (≥300 mg per 24 hours collection OR ≥0.3 mg/dL on protein:creatinine ratio OR 1+ on dipstick if neither of the previous is available)

    Preeclampsia with severe features: Elevated blood pressure after 20 weeks ≥160/110 on 2 occasions (may be within minutes to ensure medication treatment) OR,

    • Blood pressure ≥140/90 and systemic findings including: new platelet count <100,000microliter, serum creatinine >1.1 mg/dL, doubling of serum creatinine in absence of other renal disease, liver transaminases twice upper limit of normal, pulmonary edema, cerebral or visual symptoms
    • Proteinuria is not necessary for this diagnosis

    Eclampsia: preeclampsia with eclamptic seizure


  9. Gestational hypertension [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    Gestational hypertension: blood pressure elevation ≥140/90 on two occasions after 20 weeks in absence of proteinuria or systemic findings defined above

  10. Postpartum hemorrhage [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    Visual estimated blood loss >1000 mL or need for two or more uterotonics

  11. Postpartum endometritis [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  12. Composite maternal infectious outcome [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    Endometritis, wound reopened for hematoma, seroma, infection, or other reasons, cellulitis requiring antibiotics, pneumonia, pyelonephritis, bacteremia of unknown source, septic pelvic thrombosis

  13. Maternal venous thromboembolism [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  14. Birth weight [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    Macrosomia >4500 grams, large for gestational age (LGA) defined as 90th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data

  15. Duration and presence (up to 72 hours) of respiratory support [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    Including ventilator, CPAP, high-flow nasal cannula (HFNC)

  16. Small for gestational age [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    <5th percentile and <10th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data

  17. Cephalohematoma [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  18. Shoulder dystocia [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    Need for additional maneuvers to accomplish delivery

  19. Transfusion of blood products [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  20. Breastfeeding intention and initiation in the hospital [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  21. Breastfeeding at 6 weeks (exclusive and any breastfeeding) [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  22. Hyperbilirubinemia requiring phototherapy or exchange transfusion [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  23. Apgar ≤ 7 at 5 minutes [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  24. Neonatal seizures [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  25. Sepsis [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    Requires the presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebrospinal fluid (CSF), or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal X-ray confirming infection.

  26. Neonatal encephalopathy [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    As defined by Shankaran et al.

  27. Meconium aspiration syndrome [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  28. Birth trauma [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage facial nerve injury

  29. Intracranial hemorrhage or subgaleal hemorrhage [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  30. Neonatal hypotension requiring pressor support [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  31. Neonatal composite outcome [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    IUFD, neonatal death, intubation or neonatal respiratory support, Apgar score ≤ 7 at 5 minutes, seizures, sepsis as defined above, neonatal encephalopathy, pneumonia, meconium aspiration syndrome, birth trauma, intracranial hemorrhage, or hypotension

  32. Hypoglycemia [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    glucose < 35 mg/dL requiring IV therapy

  33. Admission to the neonatal intensive care unit (NICU) [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  34. Number of clinic visits post enrollment to admission for delivery [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  35. Non-stress tests, biophysical profiles (BPP), modified BPPs, ultrasounds done other than BPP, Doppler, contraction stress test [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  36. Intrauterine pressure catheter (IUPC) or fetal scalp electrode placement [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  37. Epidural use [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  38. Use of induction and ripening agents, maximum dose of oxytocin [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  39. Number of hours on labor and delivery unit [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  40. Maternal postpartum length of hospital stay [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  41. Neonatal length of hospital stay [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  42. Length of NICU or intermediate care stay [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
  43. Post discharge resource utilization [ Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. ]
    Inpatient and outpatient visits for mother and baby from discharge to 6 weeks



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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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 years and older
  2. Pregnant, singleton gestation, vertex presentation
  3. Nulliparous (no prior pregnancy delivered past 20 weeks)
  4. Pre-pregnancy (self-reported in record of in EMR within 3 months of LMP) or 1st trimester (up to and including 14 weeks 0 days) BMI ≥ 35 kg/m2
  5. Gestational age at enrollment 38 weeks 0 days and 38 weeks 6 days with dating confirmed by LMP and ultrasound performed prior to 20 6/7 weeks

Exclusion Criteria:

  1. Plan for induction of labor prior to 41 weeks 0 days for medical indication prior to study consideration
  2. Plan for cesarean delivery or contraindication to labor
  3. Major illness with increased risk of adverse pregnancy outcomes (e.g. pregestational diabetes with or without medication, gestational diabetes on medication, hypertension, cardiac disease, renal insufficiency, autoimmune disorder)
  4. Multiple gestation
  5. Non-vertex presentation
  6. Fetal death
  7. Fetus with major/lethal anomaly or aneuploidy (soft markers of aneuploidy, urinary tract dilation, isolated bowel dilation, mild ventriculomegaly, normal variants of vascular system, and isolated ventricular septal defects will not be excluded)

    a. Soft markers not qualifying as exclusion criteria: echogenic intracardiac focus, choroid plexus cyst, echogenic bowel, increased NT or nuchal fold, isolate short humerus or femur

  8. Fetal growth restriction (EFW <10th percentile or AC <10th percentile)
  9. Preeclampsia or gestational hypertension
  10. Known oligohydramnios or polyhydramnios
  11. Prior delivery after 20 weeks
  12. Placenta/vasa previa
  13. Placental abruption (known or suspected) or unexplained vaginal bleeding
  14. Previous cesarean section, myomectomy, or classical cesarean
  15. Spontaneous labor or suspicion of labor with regular contractions and cervical change, rupture membranes
  16. Active genital herpes or HIV positive
  17. Inability to consent
  18. Any contraindication to a vaginal delivery
  19. Delivery anticipated outside of Baystate Medical Center

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): NCT04035382


Contacts
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Contact: Corina Schoen, MD 413-794-3470 Corina.SchoenMD@baystatehealth.org
Contact: Laura Gebhardt, BA, CCRP 413-794-2706 laura.gebhardt@baystatehealth.org

Locations
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United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Corina Schoen, MD    413-794-2470    Corina.SchoenMD@baystatehealth.org   
Contact: Laura Gebhardt, BA, CCRP    413-794-2706    laura.gebhardt@baystatehealth.org   
Principal Investigator: Corina Schoen, MD         
Sponsors and Collaborators
Baystate Medical Center
Investigators
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Principal Investigator: Corina Schoen, MD Baystate Medical Center

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Responsible Party: Baystate Medical Center
ClinicalTrials.gov Identifier: NCT04035382     History of Changes
Other Study ID Numbers: BH-19-000
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baystate Medical Center:
BMI
Obesity
Labor induction
Cesarean section
Additional relevant MeSH terms:
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Misoprostol
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents