Labor Induction
Conditions
Keywords
BMI, Obesity, Labor induction, Cesarean section
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).
Interventions
PROCEDURELabor 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.
Sponsors
Baystate Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Simon two-stage
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cesarean section | 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
| Measure | Time frame | Description |
|---|---|---|
| Incisional extensions at cesarean section | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | J or T shape incisions or cervical trauma |
| Sepsis | 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. |
| Operative vaginal delivery and indication | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | Vacuum or forceps |
| Suspected intraamniotic infection | 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 | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Maternal death | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Antepartum, intrapartum, or neonatal death | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Admission to the intensive care unit (ICU) | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Preeclampsia | 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 | 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 | 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 | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Composite maternal infectious outcome | 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 | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Birth weight | 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 | 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 | 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 | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Shoulder dystocia | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | Need for additional maneuvers to accomplish delivery |
| Transfusion of blood products | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Breastfeeding intention and initiation in the hospital | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Breastfeeding at 6 weeks (exclusive and any breastfeeding) | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Hyperbilirubinemia requiring phototherapy or exchange transfusion | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Apgar ≤ 7 at 5 minutes | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Neonatal seizures | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Neonatal encephalopathy | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | As defined by Shankaran et al. |
| Number of hours on labor and delivery unit | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Maternal postpartum length of hospital stay | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Neonatal length of hospital stay | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Length of NICU or intermediate care stay | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Meconium aspiration syndrome | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Birth trauma | 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 | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Neonatal hypotension requiring pressor support | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Neonatal composite outcome | 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 | 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) | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Post discharge resource utilization | 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 |
| Non-stress tests, biophysical profiles (BPP), modified BPPs, ultrasounds done other than BPP, Doppler, contraction stress test | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Intrauterine pressure catheter (IUPC) or fetal scalp electrode placement | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Epidural use | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Use of induction and ripening agents, maximum dose of oxytocin | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
| Number of clinic visits post enrollment to admission for delivery | From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment. | — |
Countries
United States
Contacts
Primary ContactCorina Schoen, MD
Backup ContactLaura Gebhardt, BA, CCRP
Outcome results
None listed