Clinical trial NCT04035382: BMI-Associated Labor Induction: A Prospective Trial
Official title: BMI-Associated Labor Induction: A Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Induction
Keywords: BMI
Obesity
Labor induction
Cesarean section
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Simon two-stage
Primary purpose: TREATMENT

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

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).

Eligibility 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

Primary outcomes:
measure: Incidence of cesarean section
timeFrame: Admission for induction to discharge from delivery admission, up to 3 weeks after enrollment.
Secondary outcomes:
measure: Incisional extensions at cesarean section
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Operative vaginal delivery and indication
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Suspected intraamniotic infection
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: 3rd or 4th degree perineal laceration
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Maternal death
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Antepartum, intrapartum, or neonatal death
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Admission to the intensive care unit (ICU)
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Preeclampsia
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Gestational hypertension
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Postpartum hemorrhage
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Postpartum endometritis
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Composite maternal infectious outcome
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Maternal venous thromboembolism
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Birth weight
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Duration and presence (up to 72 hours) of respiratory support
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Small for gestational age
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Cephalohematoma
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Shoulder dystocia
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Transfusion of blood products
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Breastfeeding intention and initiation in the hospital
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Breastfeeding at 6 weeks (exclusive and any breastfeeding)
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Hyperbilirubinemia requiring phototherapy or exchange transfusion
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Apgar ≤ 7 at 5 minutes
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Neonatal seizures
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Sepsis
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Neonatal encephalopathy
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Meconium aspiration syndrome
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Birth trauma
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Intracranial hemorrhage or subgaleal hemorrhage
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Neonatal hypotension requiring pressor support
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Neonatal composite outcome
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Hypoglycemia
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Admission to the neonatal intensive care unit (NICU)
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Number of clinic visits post enrollment to admission for delivery
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Non-stress tests, biophysical profiles (BPP), modified BPPs, ultrasounds done other than BPP, Doppler, contraction stress test
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Intrauterine pressure catheter (IUPC) or fetal scalp electrode placement
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Epidural use
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Use of induction and ripening agents, maximum dose of oxytocin
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Number of hours on labor and delivery unit
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Maternal postpartum length of hospital stay
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Neonatal length of hospital stay
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Length of NICU or intermediate care stay
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
measure: Post discharge resource utilization
timeFrame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Philadelphia
country: United States
facility: Sidney Kimmel Medical College, Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Baystate Medical Center
name: Corina Schoen, MD
role: PRINCIPAL_INVESTIGATOR
References: