BMI-Associated Labor Induction: A Prospective Trial

Labor Induction Clinical Trial

— BALI  

Official title:

BMI-Associated Labor Induction: A Prospective Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04035382
• Other study ID #: BH-19-000
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Baystate Medical Center
• Contact: Corina Schoen, MD
• Phone: 413-794-3470
• Email: Corina.SchoenMD[@]baystatehealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Induction

Intervention

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.

Locations

Country	Name	City	State
United States	Sidney Kimmel Medical College, Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Baystate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cesarean section	The primary outcome is to determine whether planned induction of labor at 39 weeks for obese nulliparous women changes the incidence of cesarean section.	Admission for induction to discharge from delivery admission, up to 3 weeks after enrollment.
Secondary	Incisional extensions at cesarean section	J or T shape incisions or cervical trauma	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Operative vaginal delivery and indication	Vacuum or forceps	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Suspected intraamniotic infection	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	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	3rd or 4th degree perineal laceration		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Maternal death		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Antepartum, intrapartum, or neonatal death		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Admission to the intensive care unit (ICU)		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Preeclampsia	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	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Gestational hypertension	Gestational hypertension: blood pressure elevation =140/90 on two occasions after 20 weeks in absence of proteinuria or systemic findings defined above	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Postpartum hemorrhage	Visual estimated blood loss >1000 mL or need for two or more uterotonics	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Postpartum endometritis		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Composite maternal infectious outcome	Endometritis, wound reopened for hematoma, seroma, infection, or other reasons, cellulitis requiring antibiotics, pneumonia, pyelonephritis, bacteremia of unknown source, septic pelvic thrombosis	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Maternal venous thromboembolism		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Birth weight	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	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Duration and presence (up to 72 hours) of respiratory support	Including ventilator, CPAP, high-flow nasal cannula (HFNC)	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Small for gestational age	<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	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Cephalohematoma		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Shoulder dystocia	Need for additional maneuvers to accomplish delivery	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Transfusion of blood products		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Breastfeeding intention and initiation in the hospital		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Breastfeeding at 6 weeks (exclusive and any breastfeeding)		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Hyperbilirubinemia requiring phototherapy or exchange transfusion		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Apgar = 7 at 5 minutes		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Neonatal seizures		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Sepsis	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.	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Neonatal encephalopathy	As defined by Shankaran et al.	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Meconium aspiration syndrome		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Birth trauma	Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage facial nerve injury	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Intracranial hemorrhage or subgaleal hemorrhage		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Neonatal hypotension requiring pressor support		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Neonatal composite outcome	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	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Hypoglycemia	glucose < 35 mg/dL requiring IV therapy	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Admission to the neonatal intensive care unit (NICU)		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Number of clinic visits post enrollment to admission for delivery		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	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.
Secondary	Intrauterine pressure catheter (IUPC) or fetal scalp electrode placement		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Epidural use		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Use of induction and ripening agents, maximum dose of oxytocin		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Number of hours on labor and delivery unit		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Maternal postpartum length of hospital stay		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Neonatal length of hospital stay		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Length of NICU or intermediate care stay		From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Secondary	Post discharge resource utilization	Inpatient and outpatient visits for mother and baby from discharge to 6 weeks	From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.