BMI-Associated Labor Induction: A Prospective Trial

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021

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).

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • Operative vaginal delivery and indication
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
    • Vacuum or forceps
  • 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
  • 3rd or 4th degree perineal laceration
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • Maternal death
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • Antepartum, intrapartum, or neonatal death
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • Admission to the intensive care unit (ICU)
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • 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
  • 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
  • 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
  • Postpartum endometritis
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • 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
  • Maternal venous thromboembolism
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • 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
  • 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)
  • 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
  • Cephalohematoma
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • Shoulder dystocia
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
    • Need for additional maneuvers to accomplish delivery
  • Transfusion of blood products
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • Breastfeeding intention and initiation in the hospital
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • Breastfeeding at 6 weeks (exclusive and any breastfeeding)
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • Hyperbilirubinemia requiring phototherapy or exchange transfusion
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • Apgar ≤ 7 at 5 minutes
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • Neonatal seizures
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • 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.
  • Neonatal encephalopathy
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
    • As defined by Shankaran et al.
  • Meconium aspiration syndrome
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • 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
  • Intracranial hemorrhage or subgaleal hemorrhage
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • Neonatal hypotension requiring pressor support
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • 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
  • Hypoglycemia
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
    • glucose < 35 mg/dL requiring IV therapy
  • Admission to the neonatal intensive care unit (NICU)
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • 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.
  • 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.
  • Intrauterine pressure catheter (IUPC) or fetal scalp electrode placement
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • Epidural use
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • 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.
  • Number of hours on labor and delivery unit
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • Maternal postpartum length of hospital stay
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • Neonatal length of hospital stay
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • Length of NICU or intermediate care stay
    • Time Frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Baystate Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Corina Schoen, MD, Principal Investigator, Baystate Medical Center
  • Overall Contact(s)
    • Corina Schoen, MD, 413-794-3470, Corina.SchoenMD@baystatehealth.org

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