Labor InductionBALINCT04035382
BMI-Associated Labor Induction: A Prospective Trial
A study testing Labor induction in people with Labor Induction, run by Baystate Medical Center at 2 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Induction
- What is being tested?
- Labor induction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Pregnant, singleton gestation, vertex presentation
- Nulliparous (no prior pregnancy delivered past 20 weeks)
- 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
- 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
Who cannot join
- Plan for induction of labor prior to 41 weeks 0 days for medical indication prior to study consideration
- Plan for cesarean delivery or contraindication to labor
- 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)
- Multiple gestation
- Non-vertex presentation
- Fetal death
Show all 20Show fewer
- 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)
- 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
- Fetal growth restriction (EFW <10th percentile or AC <10th percentile)
- Preeclampsia or gestational hypertension
- Known oligohydramnios or polyhydramnios
- Prior delivery after 20 weeks
- Placenta/vasa previa
- Placental abruption (known or suspected) or unexplained vaginal bleeding
- Previous cesarean section, myomectomy, or classical cesarean
- Spontaneous labor or suspicion of labor with regular contractions and cervical change, rupture membranes
- Active genital herpes or HIV positive
- Inability to consent
- Any contraindication to a vaginal delivery
- Delivery anticipated outside of Baystate Medical Center
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Sidney Kimmel Medical College, Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Rupsa Boelig, MD, 215-995-9196, rupsa.boelig@jefferson.edu
Rupsa Boelig, MD
- Recruiting
Baystate Medical Center
Springfield, Massachusetts, 01199
Corina Schoen, MD, 413-794-2470, Corina.SchoenMD@baystatehealth.org
Laura Gebhardt, BA, CCRP, 413-794-2706, laura.gebhardt@baystatehealth.org
About this study
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
Read the 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).
- Conditions
- Labor Induction
- Being tested
- Labor induction
- Keywords
- BMI, Obesity, Labor induction, Cesarean section
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor inductionProcedure or surgery
Also called Foley catheter, Misoprostol, Oxytocin, Amniotomy
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.
| Study group | Role | What they receive |
|---|---|---|
| Labor Induction | Experimental | 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. Receives: Procedure: Labor induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Admission for induction to discharge from delivery admission, up to 3 weeks after enrollment.
Secondary outcomes (43)
Incisional extensions at cesarean section
J or T shape incisions or cervical trauma
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Operative vaginal delivery and indication
Vacuum or forceps
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
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
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
3rd or 4th degree perineal laceration
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Maternal death
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Antepartum, intrapartum, or neonatal death
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Admission to the intensive care unit (ICU)
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
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
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Gestational hypertension
Gestational hypertension: blood pressure elevation ≥140/90 on two occasions after 20 weeks in absence of proteinuria or systemic findings defined above
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Postpartum hemorrhage
Visual estimated blood loss >1000 mL or need for two or more uterotonics
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Postpartum endometritis
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
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
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Maternal venous thromboembolism
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
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
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Duration and presence (up to 72 hours) of respiratory support
Including ventilator, CPAP, high-flow nasal cannula (HFNC)
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
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
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Cephalohematoma
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Shoulder dystocia
Need for additional maneuvers to accomplish delivery
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Transfusion of blood products
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Breastfeeding intention and initiation in the hospital
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Breastfeeding at 6 weeks (exclusive and any breastfeeding)
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Hyperbilirubinemia requiring phototherapy or exchange transfusion
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Apgar ≤ 7 at 5 minutes
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Neonatal seizures
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
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.
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Neonatal encephalopathy
As defined by Shankaran et al.
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Meconium aspiration syndrome
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Birth trauma
Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage facial nerve injury
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Intracranial hemorrhage or subgaleal hemorrhage
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Neonatal hypotension requiring pressor support
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
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
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Hypoglycemia
glucose < 35 mg/dL requiring IV therapy
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Admission to the neonatal intensive care unit (NICU)
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Number of clinic visits post enrollment to admission for delivery
Measured: 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
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Intrauterine pressure catheter (IUPC) or fetal scalp electrode placement
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Epidural use
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Use of induction and ripening agents, maximum dose of oxytocin
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Number of hours on labor and delivery unit
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Maternal postpartum length of hospital stay
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Neonatal length of hospital stay
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Length of NICU or intermediate care stay
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Post discharge resource utilization
Inpatient and outpatient visits for mother and baby from discharge to 6 weeks
Measured: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start31 Oct 2019
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Simon two-stage
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corina Schoen, MD, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035382
- Sponsor's protocol ID
- BH-19-000
- Acronym
- BALI
- Status last verified
- Apr 2022
- First submitted
- 16 Jul 2019
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BMI-Associated Labor Induction: A Prospective Trial
- ClinicalTrials.gov ID
- NCT04035382
- Acronym / sponsor ID
- BALI / BH-19-000
- Conditions
- Labor Induction
- Keywords
- BMI, Obesity, Labor induction, Cesarean section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Simon two-stage
| Arm | Type | Receives |
|---|---|---|
| Labor Induction | Experimental | Procedure: Labor inductionInduction 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years and older
- Pregnant, singleton gestation, vertex presentation
- Nulliparous (no prior pregnancy delivered past 20 weeks)
- 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
- 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
Key exclusion criteria (20 listed)
- Plan for induction of labor prior to 41 weeks 0 days for medical indication prior to study consideration
- Plan for cesarean delivery or contraindication to labor
- 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)
- Multiple gestation
- Non-vertex presentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labor inductionAlso: Foley catheter, Misoprostol, Oxytocin, AmniotomyThe 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. | Procedure or surgery | Labor Induction |
Primary outcome
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.
43 secondary outcomes
Incisional extensions at cesarean section
Time frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Operative vaginal delivery and indication
Time frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Suspected intraamniotic infection
Time frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
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.
Gestational hypertension
Time frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
Postpartum hemorrhage
Time frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
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.
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.
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.
Small for gestational age
Time frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
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.
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.
Neonatal encephalopathy
Time frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
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.
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.
Hypoglycemia
Time frame: From enrollment to 6-8 weeks postpartum, average of 10 weeks after enrollment.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corina Schoen, MD principal investigator
Baystate Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labor induction in people with Labor Induction, run by Baystate Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Corina Schoen, MD (413-794-3470, Corina.SchoenMD@baystatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cesarean section (time frame: Admission for induction to discharge from delivery admission, up to 3 weeks after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.